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Patrick Massad
Deputy Commissioner

To view the PAAB
Code of Advertising Acceptance
click here



5 Most Recent Questions and Answers
  1. We have a question related to the placement of formulary messaging on sample boxes. Is it acceptable to place a formulary sticker on a sample box? If so what kind of approvals would be required to permit this action?

    Affixing something onto a product’s outer box is a labelling concern. PAAB does not review and approve labelling. Health Canada regulates labelling. I’d consult the manufacturer’s internal regulatory department for guidance on this matter. The answer would be significantly different if it related to affixing a sticker to a previously PAAB approved sample holder (i.e. an APS). Let me know if this is what you meant.

  2. Hi Patrick. Accreditation for a CHE program has expired and the company wants to turn it into an OLA. The role of the reps is restricted to logistics only and the content is all on label. The program has been developed by HCPs and is presented by trained HCP speakers. Does the OLA content need to be reviewed by PAAB? Thank you.

    Drug advertising directed to HCPs should be submitted for PAAB pre-clearance unless the exemption criteria listed in s6.6 are met. The fact that something is an OLA does not, in and of itself, exempt it from the advertising regulations nor does it render it subject to the advertising regulations. There are many factors to consider (e.g. the content, linkages, and the means/context of dissemination). PAAB has created a decision tree tool to help you work through these factors. The tool is based on the 7 questions in the Health Canada policy document “The Distinction Between Advertising and Other Activities”. The tool can be accessed through the following link: http://www.paab.ca/resources/pdfs/Guidance-on-which-HCP-materials-require-PAAB-review.pdf.

    You may choose to use the PAAB opinion service if you need an independent set of eyes to make this assessment (see the fee schedule on the website).

  3. We have an existing product with a new indication. We would like to announce the 'new' indication like "Now indicated in...". What level of fair balance would be required?

    If that’s the only message conveyed (both explicitly and implicitly), you’d need the indication and the lowest level fair balance.

  4. Where in the code does it stipulate the requirements for communication between Health Care Professional to Health Care Professional?

    The scope of the PAAB code is described in section 1 of the code. Most of the provisions throughout the PAAB code apply to drug advertising which is directed to HCPs. The provisions apply regardless of whether the advertising is distributed directly from the manufacturer to the HCP or through an intermediary. For example, advertising which a manufacturer arranged to have presented by an HCP to other HCPs would not be exempt from PAAB review. Please keep in mind that some healthcare professional codes prohibit “Peer-selling” (though there is no such provision in the PAAB code). Also note that while the scope of the PAAB Code covers messages to HCPs from drug companies, the Food and Drugs Act covers all healthcare product advertising to all audiences.

  5. If the product is in a therapeutic area where we cannot use IMS data because of market definitions, can we use patient chart study or any other form of study to show our performance in the market. Are there specific guidelines on sample or methodology?

    This sounds like a case I have not encountered before. Please call me at the office so we can discuss as I’ll need more background information. Thanks, Patrick.

  6. Are reports published from unaccredited CME events (ie. symposia) subject to PAAB approval?

    Please refer Q&A #350 and #129 for relevant excerpts from the PAAB code and the Health Canada policy document “The Distinction Between Advertising and Other Activities”. Ultimately, the answer to your question is another question. Is the report drug advertising? If so, yes the report is subject to the advertising regulations in the Food and Drugs Act, the Food and Drug Regulations, and the PAAB code. If the report is not advertising, the answer to your question is no.

    For example, the report is likely advertising if the manufacturer exerted any direct or indirect influence over the event or the report’s creation (e.g. selecting author, input on scope, review of content…etc) and the report either emphasises or favours this manufacturer’s products (or the classes in which this manufacturer has a vested interest). Feel free to use our written opinion service for an opinion on your specific report (see the fee schedule on our website).

  7. Hello, Can text from Part III/Consumer Information of a PM be used as a reference within and HCP directed piece? For example, if we were to define patient types that a product is indicated for and use the language defining such patients from Part III, would this be acceptable in HCP directed materials?

    For an HCP targeted piece, disease information defining the patient type(s) in which the product is indicated may not come from part III of the PM. For example, the content in Part III is not intended to inform the prescriber (or other HCP) about the breadth/scope/definition of the indication, related outcomes or subpopulations. This information must come from Part I of the PM (specifically the Indication and Clinical Use section). Canadian consensus guidelines can be used to elaborate on place in therapy within the indication parameters set in part I of the PM.

  8. Can you please remind me of the rules related to printing and distributing your product monograph? I believe you can reprint it exactly as is and to do so would be PAAB exempt. However, if you add a cover with your brand identity, your logo and indication statement(s), yet no claims, is that now classified as a "commercial" PM and thus requires PAAB review? Or is it only if you make a claim on a branded front cover? TIA

    We have a concise but comprehensive external guidance for promotional PMs on our website. It answers your question and also provides a broader reminder. For your convenience, click here: http://www.paab.ca/resources/pdfs/code-revision/Guidance_on_Promotional_Monographs.pdf.

  9. Are poster presentations in medical conferences acceptable as a reference for promotional materials?

    As per PAAB code section 3.1.1 & 3.1.2, the answer is no.

  10. Has there been any code infraction of late that you can share to us? And what does PAAB do about it?

    The stage 2 complaint decisions are published in our quarterly newsletter. Refer to the January 2014 newsletter for a report on the entire year of 2013. The January, April and July newsletters are also available for 2014 statistics.

    All PAAB quarterly newsletters can be accessed here: http://www.paab.ca/newsletters.htm

    Note that we only publish information about stage 2 complaints. Code infractions discovered in Stage 1 complaints, monitoring notices, and the review process are confidential.

  11. A client wishes to produce some material that will be strictly used by their medical team (i.e. MSLs, Med Affairs, Medical Education Specialists). It will contain product efficacy outcomes that will be balanced with safety and AEs, and thus will be strictly used in a non-promotional manner. The piece itself will meet the requirements of Health Canada as NOT being advertising, but they wish to have a PAAB exemption letter.

    QUESTION: Looking at section 6.6(iv) of the code, one of the exemption scenarios involves: Use of drug name only in a context not linked to therapeutic or promotional messages, other than those listed in in any way. Could you clarify what 'therapeutic message' entails? Would efficacy charts be considered a therapeutic message?

    Creating and distributing materials through the medical department does not automatically render those materials exempt from the advertising regulations. Even when the materials are created and distributed solely through the medical department, it is critical to pause and reflect on whether the content is subject to the provisions in the Food and Drugs Act, the Food and Drugs Regulations and the PAAB code. The Health Canada policy document “The Distinction Between Advertising and Other Activities” is a valuable tool in determining whether the materials are subject to the advertising regulations. PAAB code s6.6 speaks to exemptions from PAAB review while PAAB guidance document “Guidance on Which HCP Materials Require PAAB Review” (see: http://www.paab.ca/resources/pdfs/Guidance-on-which-HCP-materials-require-PAAB-review.pdf) provides additional help in distinguishing between what requires PAAB review and what doesn’t.

    From the sounds of it, the piece you are describing would only be exempt if used by the medical team in response to unsolicited requests. From the provided description, the piece would be subject to the advertising regulatory provisions (and preclearance) if used proactively. It sounds as though it is about the benefits and risks of the manufacturer's product. PAAB approved advertising is balanced with respect to risk and benefit also (i.e. this alone does not make it non-advertising). Yes, efficacy charts would be considered clinical messages. Please call if you have any questions.

  12. Referring to PAAB Code 6.5.4 - The sponsor may link to corporate global sites only by linking to the global site home page. The sponsor should not link to the global site product pages or sections.

    Please confirm if we can link to the homepage of our Corporate website for Canada (.ca) or do we have to link to the global site (.com)?

    Lastly, our source for product monographs is our local corporate website. Please confirm that we can link directly to our product monograph from our promotional websites for quality control.

    Yes. HCP gated websites can link back to the corporate website for Canada (.ca). Yes you can link directly to the PM which happens to be housed on the corporate site from product branded HCP pieces in order to satisfy the PAAB code s7.3 requirements.

    Note that, based on direction from Health Canada, the product branded pre-gate portions of prescription drug websites must not contain a hyperlink or URL to a corporate website containing product monographs. This is true even though, when taken separately, the pre-gate section of the branded site (reminder ad) and the corporate Web site (corporate message) are compliant. Health Canada considers the link between the two to exceed the restriction set out in Section C.01.044 of the Food & Drug Regulations.

    Also note that the same principle applies to non-prescription products which are indicated for the treatment of a schedule A disease (per the restrictions set out in Section 3 of the Food and Drugs Act).

  13. Can you please advise what is required to substantiate a market share claim for a prescription product (i.e. will IMS data suffice)? How long must a market leadership position be maintained in order to make such a claim? How long is the claim valid?

    Yes, IMS Brogan data can be considered for Rx product market share claims. Refer to this link for the requirements: http://www.paab.ca/resources/pdfs/supplementary-guideline.pdf

  14. We have a consumer website for our OTC product that is ASC-approved. Can we include the link to our consumer website on a HCP marketing material, which will be submitted to PAAB, if the website itself was not PAAB-reviewed?

    Yes. PAAB reviewed HCP product branded materials for an OTC product can link to a DTC website branded for the same product if both of the following conditions are met:

    1. The OTC website has been approved by a preclearance body whose scope includes OTC DTC per the Health Canada document "Health Canada and Advertising Preclearance Agencies' Roles Related to Health Product Advertising".
    2. The consumer site is identified in the HCP site as a consumer site (i.e. so as to make it clear that this not content that was designed specifically for HCPs)
  15. Could you please clarify the response to Question 232, as it seems to imply that there is no such thing as a true "unbranded" piece. The nature of the Rep-HCP interaction is such that unbranded and branded discussions frequently take place in the same call. It was our understanding that as long as there is a clear transition/distinguishing between unbranded and branded content, that pieces are reviewed separately without assuming linkage.

    Question 232 asked whether product branded and non-product branded editorial materials should be discussed in the same sales call.

    The fact that the regulations for product branded pieces and editorials are very different lies at the core of the answer to question 232. All content in a branded piece is reviewed to ensure it is within the limitations of that specific product's TMA (per PAAB code 3.1), while an editorial is reviewed under the provisions in PAAB code section 7.5. It is possible that disease or product class statements in an editorial exceed the limitations of the sponsor product's TMA. As such, a link between that product and the editorial content might contravene section 3.1 of the PAAB code and section 9.1 of the Food and Drugs Act. Code section 6.5.4 of the PAAB code identifies the most common linkage factors: proximity, appearance, sequence, and context. Detailing editorial content which was not reviewed to ensure consistency specifically with drug X's TMA in the context of a sales call in which the rep details about drug X is not that different from placing the editorial content (containing off-label info) in a different section of the product's branded piece. You've created a link whether you have a clear transition or not.

    There is indeed such a thing thing as a true unbranded piece, provided we consider the linkage principles and ensure that we don't link branded and non - branded content.

  16. How does one guage whether a disease APS has no link to healthcare advertising? (re 6.6vii)

    Code section 6.5.4 of the PAAB code identifies the most common linkage factors: proximity, appearance, sequence, and context. Materials don't necessarily need to be provided together in order to be linked.

    If you are unsure, you can always consider submitting a PAAB opinion outlining the specifics about the intended campaign materials and activities for an advisory opinion. See the fee schedule on our website for additional information.

  17. What is the process to follow if I disagree with a reviewer's ruling and want to challenge it further?

    The "Submission guidance document" on the PAAB website outlines the escalation process. For your convenience, I have pasted the relevant segment below. The policy is intended to ensure that the reviewer has had a fair chance to resolve the matter and consult internally if necessary. Here is the excerpt:

    Escalation requests will be accepted only after having discussed a written review comment with the PAAB Reviewer, responding in writing and receiving a subsequent PAAB letter about the same issue. If you wish to escalate an issue regarding and eFile, please contact PAAB administrators with a detailed reason for the request, the eFile # and points to be discusses, and the requestors contact information. The administrator will forward the request to the Reviewer of Record and the Chief Review Officer to return the call.

  18. Is the use of social media to discuss patient experience / present factual research / raise awareness of a particular medical condition allowed - without mention of the actual treatment, but with the name of a company mentioned?

    It's hard to say that you can or can't use social media to do something. I'd begin by setting aside the fact that it's social media for now. The first question to ask is whether the content/activity is drug advertising. For the purposes of the Act, advertising is defined as including "any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device". You can also refer to the Health Canada policy document "The Distinction Between Advertising and Other Activities". You need to consider all aspects of the content/activity, its creation, and it's audience. If the content/activity falls within the realm of advertising, then it is subject to the provisions of advertising. One potential consideration that jumps out is whether this content is a Help-seeking announcement (in which case the company logo is not permitted as per the aforementioned Health Canada document).

    Possibility A: It is not advertising. In this case, your next question relates to social media. Do I have the resources necessary to monitor and intervene as necessary to make sure this stays outside of the realm of drug advertising?

    Possibility B: It is indeed drug advertising. In this case, your next question becomes whether the content/activity adheres the regulations which apply for this audience. If the answer is yes (again after consideration of all factors) your next question is whether you have the resources to monitor and intervene as necessary to ensure it stays compliant with the applicable regulations.

    There are many considerations depending on the specifics of what you are doing. We'd be happy to help you through the regulatory aspects of these questions. Feel free to contact our admin team to discuss how to submit a written opinion. Also refer to the fee schedule on our website.

  19. Can you please explain the rationale behind not being "promotional" in branded patient-directed material? Product claims would seem to promote adherence, and therefore be beneficial to the patient.

    The PAAB code section you are alluding to is s6.4.3. This provision is intended to align with the federal advertising regulations for prescription products which only enable prescription drug advertising directed to HCPs and restricted consumer advertising (the latter being limited to name, price, and quantity). There are no enabling provisions for promotion to patients. Patient information must be consistent with part III of the product monograph (and this "information" is non-promotional). This information can support adherence by educating patients about how to use the product appropriately.

  20. Hi PAAB, could you please advise what is required in terms of balancing copy for NHP products?

    NHPs can satisfy the code fair balance requirements by either of the following
    (i.e. you can choose between 'a' and 'b'):

    a) including the indication AND the weblink destination to the product license within the body of the advertisement as described in PAAB code s2.4.3.

    b) including all relevant text from the TMA within the body of the advertisement (in which case a link to the TMA is not required). Per PAAB code s7.2.1, "all relevant text" means the medicinal ingredients, the recommended use, all cautions & warnings, all contraindications, all interactions, all known adverse reactions and the dosing information relating to the uses promoted in the APS. This approach also applies to homeopathic products and OTC products. The approach does not apply to any other category of healthcare product.

  21. Is sponsorship of an accredited CME event considered marketing on the part of a pharmaceutical company?

    Can the CME provider include therapeutics that are not (as yet?) approved for use in Canada for a specific indication? The product has been approved in Europe and the USA for that same indication. There is no off-label issue.
    Only the scientific evidence will be presented concerning the drug.

    Although many would say sponsored CME is a "Marketing " activity, you should be more concerned about whether or not the activity is covered under the regulations as "advertising". The reason this latter distinction is more important is that advertising is subject to the advertising provisions (and content relating to unapproved products would contravene those regulations).
    Importantly, sponsorship alone does not render content subject to the advertising regulations. The Health Canada policy document 'The Distinction Between Advertising and Other Activities' says the following:
    CME events and scientific symposia related to drugs are sometimes sponsored by pharmaceutical manufacturers. Such activities may not be advertising when they provide a forum for exchange of information on related clinical and scientific issues. The key factor in determining the status of such an activity is the degree to which the programme is independent of the drug manufacturer.
    The information may be nonpromotional in the following circumstances:

    • sponsorship by a drug manufacturer is not targeted to specific aspects of the agenda,
    • the sponsor's role is adequately disclosed,
    • the programme is directed to scientists and/or health professionals,
    • the programme allows for exchange of information/debate,
    • the content of the agenda is not influenced by the sponsor,
    • the content of an individual presentation is not influenced by the sponsor where it concerns a drug manufactured by that sponsor,
    • there is no inducement provided to participants,
    • there are no ancillary commercial or promotional activities relating to drug products,
    • the limitations of the data and of the drug are adequately discussed,
    • discussion of an unauthorized drug or indication for use includes a statement indicating that the drug/indication has not been authorized for marketing in Canada, and
    • no reference is made to the availability of unauthorized drugs through the Special Access Programme.

    Such an activity may be advertising where any of the aforementioned conditions are not met or where other factors indicate that the primary purpose of the activity is to promote the sale of a specific drug.
    Moreover, reports, edited scripts or recorded videos of the proceedings, in whole or in part, that concern a specific drug may be advertising if they are disseminated by the sponsor, or the sponsor's agent, to a wider audience after the meeting.

  22. My question is partially related to response to Q#163.

    Medical Education Programs delivered to HCPs, as per the Rx&D Guidelines (Section 9) falls into two categories: 1. CHE (accredited programs Sec 9.3) 2. OLA (Unaccredited HCP facilitated programs, Sec 9.4). Clear guidelines are provided for the role of the member employees other than CHE professionals and it estates that they may be involved in program logistics such as, but not limited to distribution of invitations and materials (9.3.2.3 and 9.4.2.4). It is also the expectation that such activities aspire to high ethical standards and are balanced.

    Taking the above in consideration, can you please clarify statement re to Accredited Program A#163 and also provide comment on same related to OLAs?

    Q&A 163 refers explicitly to programs having received accreditation.
    However, the answer would also hold for those OLA which are NOT subject to the advertising regulations. It is possible for an HCP targeted OLA to be subject to the advertising regulations (in which case, PAAB review is required). If the content is approved by PAAB, answer 163 is no longer applicable. This is because content which fits within the advertising regulations can obviously be used in promotional contexts.
    Use the 7 questions in the Health Canada policy document "The Distinction Between Advertising and Other Activities" to differentiate between items & activities which are subject to advertising regulations and those which are not. The PAAB offers an opinion service if you need help. See the fee schedule on our website.

  23. We have an app that has already received PAAB approval last year. The client will receive NOC early July for a new indication and the app will have to be updated to include this new data. How much in advance can we submit the document pre the NOC for the new indication and what documents would we be required to submit ie annotated product monograph.

    When the Product Monograph update is at Final Draft stage as confirmed by a letter from the manufacturer's regulatory department, the PAAB will accommodate up to two pre-NOC submissions incorporating content relating to the new indication. These submissions will not be subject to the standard turnaround time. As with all submissions for review, these APS require approval by the advertiser's medical/regulatory staff prior to PAAB review.

    While waiting for the final approval of the Product Monograph, the company should apply PAAB revision requests to all the items that form the launch campaign.

    Once the update to the product monograph is approved (and the pharmaceutical company receives its NOC letter with an updated control number), additional launch APS may be submitted for PAAB review. Please read the guidance document "Guidance on Submission Process" on the PAAB website for more information.

  24. Is the message "Now Approved" acceptable in APS? It seemed that at one time, this was discouraged due to the perception of Health Canada endorsement

    You are correct. It is generally not accepted as it suggests Health Canada endorsement. This is an application of section C.01.007 of the Food and Drug Regulations which was requested by Health Canada. I said "generally" because there are two exceptions which readily come to mind. On occasion, the wording "approved" appears within a product's Terms of Market Authorization (TMA). In those instances, we accept the message with the same context & emphasis as the TMA. "Approved" / "Approval" can also be considered when its context is limited to formulary coverage.

  25. Hello. Could you please clarify if the indication statement is considered a claim?

    An indication statement is a claim. BUT it does not (in and of itself) impact whether the highest, middle, or lowest level of fair balance is required. A piece with only the indication statement, would qualify for the lowest level fair balance. Please see the guidance document "Guidance on Generating the Three Base Fair Balance Levels" and "Guidance on Base Fair Balance Level Selection and Placement".

  26. In light of the new Fair Balance requirements (high level), are we required to include all the laboratory monitoring as part of the warnings and precautions section? It seems like a lot of info given that they are monitoring guidance but not warnings per se (e.g. monitor leucocytes very 4 weeks ...). Please advise.

    The short answer is "Yes". But I think the following details will help you manage the amount of information. Only content referring to monitoring instructions which do not refer specifically to a risk already stated elsewhere in the fair balance need be included. For example, if there is already a bullet referring to risk of reduction of white blood cells, there is no need to also include an instruction to monitor white blood cells. Also note that when it comes to 'Other Relevant Warnings and Precautions' (which is the heading under which this type of info would typically need to be presented if not emphasized in the TMA), you are only required to identify the issue (in this case, the need to monitor X, Y, and Z). There is no need to describe the frequency of monitoring, the thresholds that should trigger further actions...etc.

  27. Hi Patrick,

    Lately PAAB has been requesting that the indication for a product be placed on the front page of every piece. If we are not making any clinical claims on a front page of a piece, why can we not include the indication on the second page of a piece? Your PAAB code clearly says:

    2.10.2 - PAAB code, The TMA content, "Drug X is indicated for" (or equivalent) must be presented verbatim at least once within the advertising message of the APS.

    Nowhere does it say it has to be on the front page.....thanks!

    Section 2.10.1 states that this information "must be presented prominently among or prior to the first set of marketing benefit claims". Per the definition section of the PAAB code (section 11) such claim can be therapeutic or non therapeutic. The front page often (although not always) contains a claim of marketing benefit. The underlying principle is that the segment of patients for whom the product is authorized should set the context for the corresponding benefits. Also refer to the guidance document "Guidance on Indication Placement in Advertising" on the PAAB website.

  28. We are planning market research with healthcare professionals to identify new marketing insights and opportunities. The research will be in the form of informal interviews/discussions with HCPs. Does the PAAB need to be involved with the research planning? This would be organized and conducted by an agency and the sponsoring client would only receive anonymous insights and findings.

    Does the answer depend on any of the following?

    1. If interview questions are provided to the HCP in advance vs. an impromptu discussion?

    2. If the interview/discussion covers specific products vs. only diseases.

    PAAB review of market research activities is not required. The activity itself should not be geared toward promotion of a product. Make sure you are following the Rx&D code with respect to the research activity. You mentioned that your aim is to use the findings simply to help guide future strategic marketing decisions (i.e. internal uses). PAAB comes into the picture if you decide to use the findings as support for messages in drug advertising. In those cases, manufacturers/agencies sometimes submit a written opinion request (see PAAB website for fee schedule) to gain insight into whether the planned research type/method would be appropriate for the intended future advertising objectives. Also note that PAAB review is required if you intend to feed the results back to the participants.

  29. In the development of booth promotional materials intended to reprise indications, contraindications, warning and precautions which are part of the Product Monograph, are there any restrictions on how these sections can be excerpted. Is is permissible to exclude text from the indications section, for example?

    The indication statement must be presented verbatim once in the APS per section 2.10 of the PAAB code. The other segments mentioned in your question need not be verbatim but they must reflect the essence of the product monograph. Please refer to the guidance documents on the PAAB website for requirements relating to fair balance format in drug advertising.

  30. If 2 Files are received that have conflicting Reviewer comments (one favourable, one unfavourable), what is the recommended process for progressing both Files in terms of consistency Should we progress the favourable review, then cite that approval for the unfavourable review?

    Bringing the inconsistency to the attention of the Reviewers tends to lean towards a conservative outcome from the PAAB.

    If the scenario outlined in your question occurs, the first course of action is to discuss the issue with the reviewer of record. After that discussion, you have an option to contact my Deputy Commissioner Patrick Massad to discuss whether the perceived inconsistency is an actual inconsistency and how to move forward. This allows you to get to a resolution more quickly, and it helps PAAB to address consistency issues. The PAAB reviewers write around 20,000 letters per year and historically real inconsistencies are few. The PAAB struck an industry member committee to investigate consistency during the review process and found that the PAAB has a systematic process to address inconsistency. The board will decide if an audit recommendation will be approved. Thanks, Ray.

  31. Can a fractional advertising insert (on light cardboard stock) be
    - inserted
    - loose with a medical journal that is polybagged
    - or glued on the f.p.
    size : 2 1/2"x 10" or 4" x 10"
    printed on both sides
    insert to be glued on the f.p.

    In principal, these executions are possible. But keep in mind that each piece would be reviewed as a separate ad unit which is required to meet the fair balance requirements. Plan the piece with those fair balance requirements in mind. I invite you to refer to the guidance documents on the PAAB website to determine which level of fair a balance needs to appear with your intended claims and ensure that you design the piece such that it accommodates prominent presentation of this content within the main advertising message.

  32. If we believe content is PAAB exempt, due to new guidelines, do you need to review the content and how it will be used to determine PAAB exemption and then send us a letter stating exemption or not?

    There is no requirement to submit pieces which fall within the realm of exempt advertising per PAAB code section 6.6 or non-advertising per the Health Canada policy document "The Distinction Between Advertising and Other Activities". If you are uncertain about whether the piece requires review, feel free to use our written opinion service. See the fee schedule on our website

  33. Can you advise if published, qualitative studies are acceptable for patient preference claims under the new Code?

    I presume you are asking whether it is acceptable to use a survey to assess patient preferences. If I am far off of your intended meaning give me a call.

    The code change had no impact on this topic. As per before the code change, we can consider this type of presentstion when the survey was conducted by a third party receiving unrestricted funding from the sponsor (e.g. sponsor had no influence on the design, the selection of participants, creation of the survey instrument, implementation of the survey, and the analysis of the results). Preference claims must be based on statistically significant results and limited to non-therapeutic aspects of treatment (e.g. "preferred the taste of... " or "preffered the nozzle length of..."). Open claims of "preferred drug X" (i.e. without explicit limitation to non-therapeutic aspects) are not accepted from surveys. Claims of "preferred the efficacy [or safety] of..." are also not accepted based on surveys. Again, call me of this is not what you were looking for.

  34. When we have an update on our product monograph, do we need to revise the piece related to the product and resubmit to PAAB right away or we can wait for the PAAB renewal date?

    Advertising is required to be consistent with the Terms of Market Authorization (TMA) per Food and Drugs Act section 9.1 and PAAB code section 3.1. If the TMA changes such that the advertisment is no longer consistent with it, then the manufacturer must update the advertisment promptly. It is possible for the provided preclearance period to be rendered invalid by factors including TMA updates and market place changes. Please call the PAAB office if you want to discuss your specific situation.

  35. The data appearing in a product monograph is based on a pivotal trial. The same study also discusses 'off-label' endpoints. Can reps distribute the reprint of the study to support data that is in the PM?

    Before reading this answer, please read Q&A numbers 175 and 45 as they provide important background reference to the Health Canada policy document “The Distinction Between Advertising and Other Activities” and the PAAB code. Distribution of materials through a sales representative is likely to be (or eventually become) a promotional activity. Off-label promotion would contravene section 9.1 of the Food and Drugs Act.

    The scenario in the current question differs slightly from that identified in question 45; however, in that the study is a pivotal trial which presumably has data presented in the clinical trial section of the product monograph. Given this nuance, it is PAAB's interpretation that it is possible to distribute this reference through the sales rep. BUT, you’d want to ensure that the reps are trained not to discuss any off-label (i.e. non-PM) content. You also want to ensure that the reprint is the complete and unedited published and peer-reviewed pivotal trial. Also consult the Rx&D code.

  36. I'm creating a document for a drug that pharmacists will hand to the patient along with their filled prescription for this drug at the drug store. This document will include, "what you should know about the drug", "different medical conditions the drug treats" as well as "how the drug works." Will I need to add "Important Safety Information" to this document and if so what aspects will I need to include in this?

    For all sections you've listed, the content must emanate from part III of the product monograph. Where there are multiple distinct part III sections (e.g. for different conditions or formats) an entirely different document for distribution must be created. The tonality in the document must be non-promotional. Make sure you read PAAB code section 6.4.3 at the onset of your project.

    Yes, if you discuss the proposed content from part III of the PM, you should also provide safety information. This safety information should be derived from part III of the PM, not be the healthcare professional advertising safety information. As the product has already been selected, you can focus on boxed & bolded content from part III of the PM in addition to content describing what can go wrong on the medication and what to do about it (e.g. when it is sufficient to set-up a doctor's appointment versus when you need to go to the ER etc.)

  37. A product is not yet approved in Canada but approved in the US and Europe. In an international conference held in Canada, can we invite Canadian healthcare professionals to attend an company-sponsored talk within the conference auspices...and the presentation includes the unapproved product?

    No. Targeting Canadian HCPs and inviting them specifically to this segment of the event appears to render the segment subject to Canadian advertising regulations. Advertising activities targeted to Canadian healthcare professionals (HCPs) are required to be consistent with the Health Canada approved Terms of Market Authorization per PAAB code s3.1. The proposed activity would appear to contravene section 9.1 of the Food and Drugs Act and section C.08.002 of the Food and Drug Regulations. Our position is also based on the Health Canada policy document "The Distinction Between Advertising and Other Activities" which provides a list of 7 questions which help differentiate between promotional and non - promotional activities and 4 additional provisions relating specifically to international conferences.

    In addition to considering the aforementioned codes, regulations, and policies, its generally a good idea to reflect on the optics of potential marketing activities. Although it may not actually be your intent, it may appear that your intent is to promote to Canadian HCPs drugs and uses which are not approved in Canada (i.e. off-label).

    A consideration may be for the Global headquarters (not the Canadian subsidiary) to promote the international conference itself (rather than this specific segment) to HCPs from multiple areas across the globe where this is permitted (i.e. including Canadian HCPs but not targeting them specifically). Make sure you refer to the relevant provisions in the Rx&D code and follow the advice of your legal department.

  38. I was wondering where I could find information on pharma companies referring a patient to a specialist on their website or a third party website.

    I assume (perhaps incorrectly) that you are referring help seeking announcements. I.e. A piece asking consumers who have a particular medical disorder to consult a physician for discussion of treatment, or call a 1-800 number or visit a website. If so, I direct you to the following link.

    http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/actv_promo_vs_info-eng.php

    Such piece should not identify specific drugs. The drug manufacturer may not be identified either. Visit the link for the rest of the requirements relating to this sort of piece.

  39. Would the discussion of the bioequivalence of a particular product be considered to be a non-pharmacologic claim? If the piece included bioequivalence data (and no other claims) would the lowest level of fair balance suffice?

    Claims of bioequivalence are pharmacokinetic in nature. A piece containing only such claims (with the indication) would require middle level fair balance.

  40. What are the rules/regulations of non-pharmacological aspects on branded pieces. For example are questions about symptoms acceptable?

    I am unsure whether the question refers to HCP branded content or patient branded content. I am also unclear what type of symptom data is presented and in which context. For example, are we talking about which symptoms are addressed through certain non-pharm tips, are we talking about differential diagnosis, or are we talking about symptoms of the condition in general?
    I'll therefore respond in broad terms highlighting what, in my experience, clients tend to be most surprised about when dealing with disease information. This is not meant to be a comprehensive list of all potential pitfalls. The provisions discussed relate to PAAB code s3.1.

    All information in a branded APS is required to fall within the limitations of the TMA. Clients are sometimes surprised to learn that disease content is restricted by the featured product's authorized indication. Also, note that specific symptoms which are called out in APS should generally be identified in the TMA. For HCP adverting, clients are sometimes surprised to learn that some disease information presentations trigger the need for quantification of the drug's effect on the highlighted disease issue. For example, the message "72% of patients with allergic rhinitis say that their symptoms are affecting their quality of life" would require inclusion of clinical trial data (meeting all relevant PAAB code requirements) which communicates the extent to which the promoted brand improves QOL vs the active or inactive comparator.

  41. Does "coming soon" on an approved product require PAAB approval?

    Section 6.6 of the PAAB code conveys that a product branded APS is exempt only if it does not contain (and is not linked to) therapeutic or promotional messages other than those listed in explanatory note 6.6(iv)a.

    "Coming soon" is not one of those messages. The claim "Now available" is included in explanatory note 6.6(iv)a to empower manufacturers to promote the product's availability as soon as the product is approved. The claim "coming soon" is not the same message. PAAB ensures that the manufacturer is aware that the APS can only be employed once the product is approved and that the APS contains lowest level fair balance (i.e. indication and linkage statement to the TMA).

  42. Once a patient website for a medication is PAAB approved, do the footnotes and references need to appear in the copy of the live site?

    Let us know at the initial submission stage whether the reference list will appear within the patient information piece. Although the PAAB code does not require a reference list to be included in patient information, we do review the list per s4.4.4 when the manufacturer intends to include the list in the piece. Either way, note that we require the reference list (and annotated references) for our review of the APS content. Footnotes which are approved as part of the copydeck must appear in the piece. In fact, all APS content must always appear exactly as approved.

  43. Our client would like to have a website about the features of its medical device (a self-injection device). The website would not mention the name of the drug that goes in the device but it would mention the therapeutic area. The intended audience is patients who would be directed to the website by their HCPs. Am I correct that this website requires PAAB pre-clearance?

    What if the website had content only about the features of the medical device and did not mention the drug product in any way and did not mention the therapeutic area, would it then be exempt from review since the PAAB doesn't review medical devices? Or would it require pre-clearance because it is sponsored content that patients are being directed to? Thanks in advance for your response.

    Federal law requires you to promote the approved name of the product within the federal category in which it was approved. If it is approved as a drug then it requires PAAB approval. If it is a medical device (i.e. a category I, II, III, or IV medical device) no approval is required.

  44. Hi There,
    Our client has just received NOC to a new product. They do not have a large Sales Force and therefore is not looking to develop comprehensive materials. They would like to take their approved Product Monograph and highlight key messages within it - not changing any copy/content - but just simple draw attention to specific sections, such as patient groups, efficacy and adverse events. We would submit the highlighted PM through PAAB for approval - but before we go into development I just wanted to confirm this would be something PAAB would allow.

    Please refer to the Guidance document about promotional monographs on our website:
    http://www.paab.ca/resources/pdfs/code-revision/Guidance_on_Promotional_Monographs.pdf
    PAAB would not accept placing highlighting over some sections of the monograph content. Modifications should be presented in such a way as to be clearly distinguished from the PM itself. Per the aforementioned document, you could employ callouts in the margin of the document to meet your desired objective.

  45. Can we create a comparative timeline of 2 products (1 ours and 1 a competitor) from the same therapeutic category and who have some of the same indications?
    The timelines would only show indications, which ones each product has and when they were received.
    Thank you.

    Comparisons of product properties are permissible as per Code section 5.10.2iii. The comparison should be complete, with no information relevant to the comparison omitted (e.g. the indications must each be complete). The comparison must not appear in the context of messaging implying clinical significance. A disclaimer is required as outlined in the above noted Code section. With regards to the dates, keep in mind that there should be no direct or indirect reference to the approval process ad per c.01.007 of the Food and Drugs regulations.

  46. Good morning, regarding a patient care program related to a specific drug that pharmacists can participate in to support their patients, does a document communicating:

    • what the program is about, including that it's for patients diagnosed with illness A and prescribed Drug A (no claims or any other info about the drug)
    • how the program benefits the patient
    • how to enroll

    Does qualify as a document requiring PAAB approval?
    Thank you very much in advance.

    Yes.

  47. Dear PAAB, what difference does it make when we combine data from duifferent sections of the TMA (PM). i.e can we put data from the clinical trial section and the adverse event section together since the adverse events are from the clinical trials?

    In general, clinical trial data and its related adverse events from the same trial may be presented together when taken from the TMA. However, adverse events that are from combined clinical trials may not be presented such that it appears to come from the single source. It should be clearly labeled and appear distinct from the single clinical trial data.

  48. Would categorizing a video as "Unlisted" within YouTube be adequate access control for HCP branded or unbranded content provided the link to the video were only given to people who were known to possess proper credentials?

    When a link is distributed in a controlled manner limited to HCPs and it is the only way to access the file, then file access control is adequate by definition. I am assuming the link would not be simple for a consumer to guess.

  49. Dear PAAB, If data or statements exist in the product monograph but has no statistics associated with it, is it approvable?

    Content in the PM is approvable provided context and emphasis is similar to the PM. In your example, be careful not to add meaning which is not conveyed in the PM.

  50. A patient information brochure will NOT mention the product but will bear the name of the manufacturer. It will be distributed by the rep to the requesting health care professionals. Will this still need PAAB review?

    A patient piece generated by the manufacturer or its agent requires PAAB review unless both of the following conditions are met:

    • there is no discussion of drug therapy (by product, class, or category)
    • there is no discussion of drug issues (e.g. adherence to medication, potential implications of product ingredients…etc )

  51. If the printed PI pages are directly adjacent (or directly after) to the 4C display page, is it necessary to have the "I" icon box on the creative page? Can the "I" icon box be completely removed?

    I'll presume you are referring to journal ads which have been reviewed under the old code (as the question would be moot in the context of a piece reviewed under the new code). With that said, the answer to your question is "no". You can visit www.paab.ca for the revised PAAB code and corresponding guidance documents.

  52. I am confused on how Section 6.6vii is different from Consumer Brochures in "The distinction between advertising and other activities". The only differences I can think of is audience (patient vs. consumer), branding (branded vs. unbranded) and treatment discussion (no mention of treatment vs. objective discussion of all available treatments). Am I on the right track? Thanks!

    There are very different regulatory implications to meeting the provisions of any type of non-advertising from the cited Health Canada document versus meeting the provisions of any of the subsection of PAAB code 6.6. The former means the piece is exempt for the advertising regulations in the Food and Drugs Act and the Food and Drug Regulations while the latter simply means that PAAB pre-clearance is not required. You provided some examples of how the requirements differ functionally. The complete Distinction document can be found at:
    http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/actv_promo_vs_info-eng.php
    Given the differences, it is essential to generate the piece with the desired endpoint in mind.

  53. HI, will the new market created by HC under the MMPR require the Licensed Producers to work with the PAAB?

    The Healthy Environments and Consumer Safety Branch (HECSB) of Health Canada is responsible for the regulations and associated medicinal marihuana activities. All requests for clarification and complaints surrounding the advertising of medicinal marijuana should be directed to this Branch. As you may know, the primary basis of PAAB review is the Terms of Market Authorization (TMA). We’ve been informed that as medicinal marihuana is not an authorized health product and there will be no associated health claims, a TMA will not be issued. The PAAB will therefore not be reviewing advertising for medical marijuana. Note that advertisements for medical marijuana will be required to adhere to certain provisions of the Narcotic Control Regulations (NCR) and the Food and Drugs Act (FDA), regardless of the new Marihuana for Medical Purposes Regulations (MMPR).

  54. There seem to be some inconsistencies within the answers provided in this forum. In Question 313, PAAB replied that the indication does not constitute a 'claim' while in Question 303, PAAB stated that the indication is indeed a 'claim'. Could you please clarify your position. I'd argue that the indication is a claim as it refers to a therapeutic/ clinical effect.

    An indication statement is a claim. BUT it does not (in and of itself) impact whether the highest, middle, or lowest level of fair balance is required. A piece with only the indication statement, would qualify for the lowest level fair balance. Please see the guidance document "Guidance on Generating the Three Base Fair Balance Levels" and "Guidance on Base Fair Balance Level Selection and Placement".

  55. What are the limitations in terms of advertising for OTC pharmaceutical brands with a DIN?

    I'll assume the question relates to HCP advertising. For any healthcare product (as defined in section 11 of the PAAB code), regardless of its federal schedule, advertising must be contistent with the Terms of Marketing Authorization (TMA). Where the reference for a particular claim is something other than the TMA, the reference must meet all rigors required in the PAAB code (which from an evidentiary perspective are identical for Rx products versus non Rx products). For fair balance requirements relating to OTC products, refer to PAAB code section 2.4.3.

  56. hello, in today's world, many interactions between industry and HCP'S are electronic. Often, a client will ask a questions via email to their representative. Any specific regulations about representative having "email conversations" with their clients?

    As per section 6.6(ii) of the PAAB code, personal correspondences are exempt from PAAB preclesrance. See Q&A # 308 for more info and some caveats.

  57. Hi Patrick. I would like to know if you would consider this tag line "Because every day is special" a claim that would require to be supported by data (our medication increases overall survival). Thanks alot for your answer :)

    This is a forum for Q&A on the general meaning and application of the PAAB Code of Advertising Acceptance and not for reviews. You may submit an opinion request for assessment on whether there is a way to revise the claim so as to render it consistent with the product's Terms of Market Authorization and data. See the fee schedule on the PAAB website and call our admin team if you have any questions.

  58. Does an indication statement constitute a therapeutic benefit/claim or efficacy statement in and of itself? If so, can you confirm that any APS with the indication statement on it would require highest level fair balance?

    A piece with only the indication statement, would qualify for the lowest level fair balance. Please see the guidance document "Guidance on Generating the Three Base Fair Balance Levels" and "Guidance on Base Fair Balance Level Selection and Placement".

  59. What are the steps to review and approved a website? Does the content of the site may be revised first as independent, indicating the titles subtitles, main menu, submenu, boutons, etc..? And then once approved texts, we submit the entire site with images of each page and approuved content .

    Or should we submit from the first revision the entire website as one ASP needed to be revised with images of the design which will present content that not approuved?

    The PAAB cannot review off a live site. Therefore, the submission must clearly/fully describe all electronic functionalities. Generally speaking, if both languages are to be produced, we will review the English copy and layout and then ask for French translation.

    The initial submission should include:

    • a site map and wireframe
    • a layout (if a layout cannot be provided at initial submission, a detailed wireframe must be provided).
    • description of gating mechanism where relevant
    • identification of all intra-site links and company/agent generated external links that direct to and away from the website (e.g. search engine marketing, banner ads, other websites, etc.);
    • the site rules and monitoring/moderating policy (if the website offers user generated content functionality)
    • keyword metatags and metadescriptors for search engine optimization (if the client is setting these).

    If the website is large, split the site into modules (within the same eFile) which fit the system maximum document size of 20 MB. The file name for each module should correspond to the same numbering scheme used in the provided site map.

    The layout requirement can generally be addressed by screen shots once the piece is near copy approval.

    The following parts of a website are required to be separated into different eFiles:

    • Segments of a website which are targeted for different regulatory audiences (i.e. HCP vs patient vs consumer)
      Exception: The landing page on an HCP/patient website is accessible to the general public, but it may be submitted in the same eFile as the HCP/patient website
    • Sections of a website pertaining to different products e.g. in a gated portion of company X’s corporate site, there is a section for drug ABC advertising, a section for drug DEF advertising, and a section for drug GHI advertising. The section for ABC, DEF, and GHI should be submitted separately
    • Standardized correspondences generated through participation in activities through the site (e.g. email/text messages)
    • Documents available for download which are created by (or influenced by) the manufacturer/agent e.g. dose cards, product brochures, newsletters
  60. If a disease state can cause mortality, but products in that class are not indicated to improve survival/ reduce mortality (they are indicated to treat the disease), can mortality be discussed in a disease context if the same piece also discusses therapy options (editorial piece), or in the case of a branded piece a specific product? Would their be a need to completely separate the discussion of mortality in a disease-only piece that would have to be discussed in a separate call from any branded messing or discussion of therapy?

    Disease info exceeding the indication may not appear in a product branded piece (even disease content is restricted by the authorized indication). In an unbranded piece, disease content in the context of discussion of product class/category should be within the TMA of at least one of the products within that particular class/category. Such outcomes must be discussed in a manner which is separate & distinct form drug therapy.

  61. Can a third-party disease awareness pamphlet (e.g. sun safety, skin cancer awareness) be displayed at a product booth that also has branded product material attended by a sales representative?

    The key issue to consider here is whether the linkage between the product materials and the disease materials is appropriate. Your answer is "yes, provided the independently generated disease materials are not modified in any way and they are not overtly off-label

  62. Is the definition of "TMA" equivalent to or broader than the Product monograph? Are in-vitro studies on the MOA of a drug or drug components submitted to and reviewed by Health Canada as part of the NDS acceptable for use as supporting reference to non-clinical claims in promotion materials (as data on file) even if the published reference is not in the actual bibliography of references in the PM?

    A product monograph (PM) is only one example of a terms of market authorization (TMA). For example, the Product License is another form of TMA used for natural health products and homeopathy products. Data on file (DOF) is generally not an acceptable reference to support claims in HCP advertising. In order for PAAB to approve DOF, there must be clear proof of acceptance of the DOF by Health Canada (e.g. inclusion in the PM). We do not presume that all content within the reference in question are approved by Health Canada merely by virtue of being submitted as part of the NDS. For products having a product monograph, the MOA in advertising should be within the limitations of content presented in the product monograph.

  63. HI there, Could you please elaborate on the exempt nature of personal correspondence (i.e. email between HCP and rep)? Under what conditions does that correspondence require PAAB review?

    Advertising to HCPs other than that covered in section 6.6 of the PAAB code requires PAAB approval. The PAAB code section 6.6 defines "personal correspondence as" single letters carrying a personal response or message. BUT it goes on to explain that this exemption does not apply to multiple personal letters initiated by the company. It is important to note that this code section only exempts a piece from the process of preclearance. Note that this section of the PAAB code only exempts a piece from PAAB preclearance, it does not necessarily exempt it from the advertising provisions in the Food and Drugs Act. For example, a drug rep sending an email to an HCP about off-label use of his/her product may be found to have contravened the Food and Drugs Act (even though it was only sent to a single person). Use the Health Canada policy document "The Distinction Between Advertising and Other Activities" to determine whether it falls under the advertising provisions. The section on "Unsolicited requests for information" will probably be particularly relevant to your question. Please do not hesitate to submit a written opinion to the PAAB if you'd like our thoughts on the specific activity you have in mind. Please refer to the fee schedule on our website wwww.paab.ca

  64. With more 'digital detailing' from reps to physicians using iPads and tablets, many software platforms offer the ability to re-order slides in a presentation. As PAAB approves these materials do they approve them in the order reviewed only, or as individual slides / videos etc that can be re-ordered by a drug company without further approval?

    The slides are approved only in the order in which they have been reviewed. Preclearance is most effective as a regulatory mechanism when promotional tools are used in the precise way in which they were reviewed. Please refer to Q&A # 198 for a solution on how to leverage some of the functionality you are describing.

  65. Are we able to re-purpose the content for one previously-approved medium (i.e. a poster) into a completely different medium (i.e. a magazine ad) without having the re-submit? Some items might be re-arranged to fit the new sizing.

    Content of a previously approved piece may only be re-purposed into a different medium so long as no copy, layout, flow, visual, or functionality changes are made as a result of the re-purposing. Therefore, in response to your specific question, any rearranging of content as a result of resizing will require further review (i.e. the new medium should be submitted in the form of a new eFile). Furthermore, all PAAB code requirements must be maintained in the new medium. For example, if the approved APS was employing middle fair balance on the surface of the journal ad to direct to highest fair balance elsewhere in the publication, simply digitizing the journal ad would not meet the fair balance disclosure requirements. The new medium ad will require either a change in copy (e.g. use of the highest fair balance on the surface of the new medium ad) or a change in functionality (e.g. addition of an electronic link to the highest level FB). Either of these changes would trigger the need for PAAB review.

  66. For search engine marketing, our researcher has indicated the French speaking and English speaking Canada use different vocabulary when searching for our therapeutic disease sites or product web sites. We have traditionally had our PAAB approved Search Ads and keywords directly translated from English into French and then submitted the French for Approval.

    It is reasonable to provide latitude for slight deviation between English and French keywords (i.e. the English and French keywords don't have to match 100%) provided that the overall theme is the same. However, if the gap between English and French is so wide as to essentially represent two different reviews, our admin team will simply instruct you to separate the two languages into to submissions (i.e. two $390 base fees rather than one $450 base fee). Note that although the rationale you provided could be argued to apply to many other types of APS, this latitude would not apply more broadly. The nature of the keywords assessment simply lends itself quite well to this flexibility. Note that the generated description should be a direct translation.

  67. If a PAAB opinion is requested for a specific, does a positive or negative opinion affect the outcome of a subsequent clearance review?

    You'll see that there is an association between opinions and latter submissions of same/similar content. This is best described as a correlation (which is indicative of consistency) rather than a causative relationship. For example, if XYZ is not acceptable, it will be questioned whether it is submitted as an opinion or a full submission. However, the fact that something was questioned earlier does not in and of itself render it unacceptable (what renders it unacceptable is likely whatever triggered the comment in the first place). Note that this correlation is not absolute. On occasion, something is questioned in an opinion submission, but is accepted in the following complete submission because the client addressed the concerns (e.g. by providing acceptable evidence to support the claims and/or by adjusting the context). Submitting an opinion does not impact the PAAB timelines associated with the eventual complete submission. However, the line by line review during the complete submission process may run smoother if PAAB feedback from the opinion is incorporated onto that complete submission.

  68. According to the PAAB Guidance on Base Fair Balance Level Selection and Placement, the indication statement is not a 'claim' that requires fair balance. Therefore if an APS contained only the Drug name (including active ingredient and dosage form) and the indication statment, and no other explicit or implicit claims, would this APS require any fair balance? Would it be exempt from preclearance?

    The indication is indeed a claim. But it is sufficiently "balanced" with lowest level fair balance general statement (i.e. complete indication with the statement to consult the PM for contraindications, warnings...). The piece you've described is not exempt. Per the document cited in your question, product advertising is only exempt there are absolutely no messages other than drug name +/- claims explicitly listed in the PAAB code s6.6.

  69. If the audience is not hc professionals and not consumers- somewhere in the middle (private drug plan managers)- how should this audience be treated?

    Pieces targeted to HCPs and groups which may be comprised of HCPs in addition to other specialized individuals responsible for making decisions about drug therapy which effect affect Canadians (e.g. Private drug plan managers) would fall within the scope of the PAAB code. Content factors will therefore be pivotal in determining whether the content should be submitted for PAAB review. Here are some key considerations:

    • Materials provided “reactively” upon specific request are exempt from PAAB review.
    • Formulary kits prepared for review by formulary committees are exempt from PAAB pre-clearance provided the content contained therein follows that committee’s submission policy. Where such policy does not exist, the piece would still be exempt if the manufacturer ensures that the provided information is limited to that which would normally be required to support an application. Where this information package is disseminated, in whole or part, to a wider audience simultaneously, or at a later date, it may be advertising to promote the sale of the drug concerned (in which case it should be submitted for PAAB review).

  70. Does clinical trial advertising material need to be precleared? If so, by who?

    Messages/announcements aligned with the "Clinical Trial Recruitment" section of the Health Canada policy document "The Distinction Between Advertising and Other Activities" are not subject to the advertising provisions in the PAAB code. Having said that, PAAB offers an advisory opinion based on the aforementioned Health Canada document. This opinion provides the assurance of an objective external review that the message/announcement is indeed aligned with that Health Canada document. Note that, in some cases, a Telecaster number may be required for broadcasting media (e.g. television and/or radio) and receipt of that number may be contingent on demonstration of a "no further comments" letter from PAAB or ASC. Note that HCP advertisements require PAAB review whether they contain Clinical Trial Recruitments or not. Please refer to the Rx&D Code of Ethical Practices for guidance on activities related to retaining the services of a stakeholder and communication with stakeholders involved in post registration clinical studies.

  71. We are considering eMail marketing targeting our physicians in our campaign plans. We have several products in one therapeutic class. We would like to limit the number of emails sent to HCPs in order to be respectful of their time. Is it possible to send a single email with more than one brand in the email?

    Yes, it is acceptable to co-promote products in one APS. Content will be reviewed in the context of all the promoted products. Attachments, if any, should be submitted as separate APSs but please advise that they are associated with the email. They will be reviewed in the context of the email.

  72. We have videos that demonstrate how to use our product. The video is branded but does not extend beyond name, price, quanity. Is it acceptable to not gate this piece of information? If yes, are there any concerns with posting this on YouTube as a credible source on how to use our product?

    "How to use the product" can mean a couple of different things. Nonetheless, if the video is about the sponsor's product, the advertising provisions would appear to apply (in which case, in the non-gated context you've described, the video would be subject to section C.01.044 for the Food and Drug Regulations if it relates to an Rx product). Discussion of the how/who/when/where/why relating to administration/use of the product would appear to be in excess of the name, price, and quantity restriction. Note that this is not a PAAB code issue. It is an opinion based on PAAB's interpretation of the Food and Drug Regulations.

  73. We have a DTC/I campaign moving forward (disease awareness, unbranded). In the treatment section, there will be an outline the different medication options indicated for treatment of this disease. A listing of the benefits and risks associated with medication will also be listed.

    Because this is a DTC/I content and it contains a listing of ALL indicated products with no links to branded sites, we believe this to be PAAB exempt. What is your recommendation?

    The concept of "Exemptions" does not apply to DTC as PAAB provides advisory opinions for DTCA/I (i.e. manufacturers have the option to seek a DTC opinion or not). PAAB should review the content if it is created for use by HCPs or patients. Note that PAAB's advisory opinions are assessments as to whether materials, based on Health Canada's policy The Distinction between Advertising and Other Activities, are promotional, in which case they must be in accordance with the F&DAandRegulations, CDSA, and associated policy and guidance documents. PAAB provides advisory opinions on messages directed to consumers for prescription drugs (e.g., reminder ads), material discussing a medical condition or disease (e.g., help seeking messages, consumer brochures), Schedule D drug (biologics, including vaccines) advertisements, and other messages or materials (e.g., clinical trial recruitment announcements, press releases, institutional messages, etc.). PAAB has been providing objective review of DTC since the 1990. I refer you to the following link which outlines the roles of pre-clearance agencies and Health Canada: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/role_apa-pca-eng.php

  74. Hi Patrick. Can you direct me to the section of the PAAB Code that outlines the potential for use of marketing research data / findings in an APS?

    PAAB code 4.2.2 states: "The advertiser must honor market research company agreements and must submit a release of market share claims from the source of the data. Data should be the most current available, at least within the past six months". But all other provisions of the code applies. Please don't hesitate to call us if you have more specific follow-up questions.

  75. We understand how gating works for things like banner ads on sites where medical registration is required to log in. On sites where any user can purchase access (medical journals, for instance), or where large institutions like universities often have blanket access, is a post-login screen still considered "post-gate" for advertising purposes?

    If an advertisement exceeding the restrictions set out in Section C.01.044 of the Food and Drug Regulations is displayed on a Web site, and is accessible to individuals who are not healthcare professionals (HCPs), it would likely be considered in contravention of this regulatory provision. The type of login (e.g. through an institution's IP) would not be meaningful if it is allowing access to this material by non-HCPs. The key factor would be who may access or be exposed to the ad. It is therefore important for the market authorization holder to ensure that an adequate mechanism is in place to limit exposure to HCPs.

  76. Hi there, I was wondering if your review procedure for DTCA and DTCI advisory opinions occurs in accordance with chapter 8 and s 9.8 of the PAAB Code. More specifically, do you have the same rights to clarification by telephone or correspondence, meeting, escalation to the Chief Review Officer, and appeal? Thanks in advance for your answer.

    Although the PAAB code is not the basis of review for DTC (i.e. the review is based on Health Canada guidance documents), section 8 of the PAAB code relates to the administrative aspects of PAAB review and much of these are consistent between DTC and other submission types. The key exception relates to turnaround time. Our mandate is to provide a first response for DTC submissions within 4 business days (as opposed to 10 business days for HCP advertising & patient information). As with any PAAB submission, if you disagree with a PAAB correspondence received after having discussed that particular issue with the reviewer and responding to PAAB in writing with your position, you may set up a call involving the CRO, the reviewer, the manufacturer, and the communication agency. However, with regards to appeal to a panel as described in section 9.8, things are very different in the DTC realm. The nuance here is the difference between a PAAB ruling based on the PAAB code (i.e. HCP advertising and patient information) and a PAAB advisory opinion on DTC messages. The DTC advisory opinions are assessments as to whether materials, based on Health Canada's policy The Distinction between Advertising and Other Activities, are promotional, in which case they must be in accordance with the F&DAandRegulations, CDSA, and associated policy and guidance documents. PAAB will therefore consult directly with Heath Canada when there is disagreement on how to interpret these documents. For clarity and completeness, I should point out that PAAB provides advisory opinions on messages directed to consumers for prescription drugs (e.g., reminder ads), material discussing a medical condition or disease (e.g., help seeking messages, consumer brochures), Schedule D drug (biologics, including vaccines) advertisements, and other messages or materials (e.g., clinical trial recruitment announcements, press releases, institutional messages, etc.). PAAB has been providing objective review of DTC since the 1990. I refer you to the following link which outlines the roles of pre-clearance agencies and Health Canada: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/role_apa-pca-eng.php

  77. Hello, I have a piece that is being reviewed and will likely be available before my required date of 1st use. Is it possible to align the PAAB expiry with the timing of use of my piece.

    Yes, if your piece is approved prior to your 'intended date of use', we can forward the start date of the acceptance period by a maximum of 3 months from the date of approval. Please advise PAAB of your intended date of use as part of your eFile submission or notify us during the active review process that this date has changed. Please find the link to our Submissions Guidance document and refer to the bottom of page 1 for additional information. http://www.paab.ca/resources/pdfs/code-revision/Guidance_on_Submission_Process.pdf

  78. A pharmaceutical company has provided an unrestricted educational grant for the development of a disease-focused patient website. Can sales reps distribute postcards promoting the website (site name, disease focus, URL)?

    From your question, it would appear that the piece is intended to be non-promotional. Assuming this to be the case, it is important to consider that distribution factors can render non-promotional content to be subject to the advertising regulations. As a general rule of thumb, if you want something to stay non-promotional, don`t add promotional elements (e.g. promotional cards, drug reps...etc). Having said this, drug reps may distribute a postcard promoting this type of website to HCPs, but this would render the website subject to PAAB review (i.e. we`d review the card and the website). Note that the card should be non-branded if the site is non-branded. Also note that drug reps should not distribute content directly to patients.

  79. Hi, I'm sending this request for clarification on the new PAAB code: section 3.1.6 of the new code states: 3.1.6 Footnotes in close proximity may be used to augment information presented in the body copy. Information that is important for a clear and accurate understanding of a product claim must not be relegated to a footnote. Example - an indication or dosage that is limited or that is restricted to a specific group of patients. compared to the previous code which states: 3.1.6 Footnotes in close proximity may be used to augment information presented in the body copy. Information that is important for a clear and accurate understanding of the indications or dosage of a product must not be relegated to a footnote. Example - an indication or dosage that is limited or that is restricted to a specific group of patients. can you please clarifiy the implications or give examples on how the new point 3.1.6 differs from the old one? thank You!

    The core principle is that a claim should not rely on mice-type to save it from being misleading. The issue is potentially broader than the indication or dosage (hence the broadening in the new code). For example, just yesterday I saw the claim "Now covered as a general benefit" in an APS intended to be used across Canada. Nothing out of the ordinary here right? Well, the claim was cross-referenced to "Covered as a general benefit in Province X, covered with special authorization in Provinces A, B,C, and D". This has nothing to do with indication and dosing, but the principle in s3.1.6 should still apply.

  80. My understanding is that advertising of medical devices such as injectors are not governed by PAAB. However, if a auto-injector can only be used with a specific medication, and one advertises the injector to consumers, is there not a direct association of device & drug? In other words, if the device is so closely connected to the drug, should it not also be subject to PAAB advertising rules, despite the fact that technically, it is a device, not a drug?

    Claims related to Class I, II, III, and IV medical devices as defined in the Medical Device Regulations (MDR) do not fall under the current scope of the PAAB. However, messages relating to drugs fall under the scope. The answer to your question therefore depends on whether the APS messaging relates to an entity which is classified as a drug or as a medical device. I note that your question relates specifically to DTC. Contrary to your question, PAAB assessments for consumer materials are based on the Health Canada guidance documents (not the PAAB code as suggested by "PAAB advertising rules").

  81. We are placing promotional branded banner ads (no claims) in third party HCP gated websites that will drive traffic to our own gated HCP specific website. The third party site is intended for HCP's only. a) As the third party site audience is validated to be HCPs only, is this sufficient to enable bypassing our gating mechanism and bringing the HCP directly into our site? b) We are intending to bring the HCP to our top level product overview page. For future use, are there any issues with deep linking the physician into other areas of the website? (ex: Dosing, patient support, safety)

    I presume from your question that both your banner and your website are product branded. I also presume that the banners have run of site in the third party website (optimally with exception rules as described in Q&A 283). With this understanding, here are the answers to your two questions:

    A) yes (provided the manufacturer has ensured that there is an appropriate mechanism which validates HCP status on the front end).

    B) There is no outright prohibition against linking such banner to pages other than the homepage. But as some specific linkages may not be appropriate, we should be informed of where the banner links to during the review for our initial assessment of the APS. We should also be informed if the content on that link destination page changes in time. For banner ads containing claims, please refer to the guidance documents on our website for web destination requirements relating to prescribing information and fair balance.

  82. For a branded patient education brochures focused on disease/symptom management with only general (drug class-based, non-promotional) mentions of treatment, would disease-related information sourced from a national non-profit patient association be acceptable?

    I suspect there is a typo in your question. A branded patient piece may not discuss the broader product class or other product classes/therapies. Branded patient information is supposed to educated simply about the prescribed product and the medical condition. With that said, in either a proper branded or unbranded patient piece, a standard setting organization (e.g. the source described in your question) could be considered provided the content complies with the other code sections (e.g. s3.1).

  83. If we are to conduct comparative analysis (our product vs. marketed products from the same category) to support a claim to be presented to HCP, what are the standards that the study and resutls should meet for PAAB to consider it acceptable?

    I need a bit more info to provide an answer. Please clarify the following two parameters:

    • the nature of the comparison
      i.e. therapeutic comparison relating to efficacy/safety, pharmacoeconomic comparison, retention, format availability, other non-clinical features (e.g. receptor affinity/potency, MOA, preference, cosmetic/sensory attributes), etc…
    • the nature of the source
      i.e. a survey, a published clinical trial, product monographs, third party data, etc…
  84. PI, when required or when necessary, must form an integral part of the advertising message, which may be accomplished via a reference to a website link in a printed piece or by a direct electronic link to a website. If I am reading this correctly, as long it is placed on the ad page where they can find full prescribing information, I do not have to include prescribing information with my publication. Thank you

    As of July 1 2013, Provided the fair balance is formatted per the guidance on the PAAB website (which includes a URL to the complete product monograph) the publication is not required to contain the PAAB format prescribing information.

  85. After putting the NOC/c boxed statement on the front cover, can additional related statements go on the inside of the APS - or does it all have to appear on the front cover?

    I think you are referring to the base fair balance (correct me if I am mistaken). The base fair balance may appear inside of the booklet. Of course, there are times when a specific claim on the cover triggers the need for a particular element of the fair balance to be presented on the cover (i.e. copy-specific balance).

    As of July 2013, the PAAB code will require content setting the boundaries of patient selection from the Indication and Clinical Use section of the product monograph to be presented on the first surface containing drug claims. This requirement is already in place for new products, but it will apply to all healthcare product advertising reviewed by PAAB as of July 1st 2013. If this information is already conveyed in the NOC/c box, there is no need to repeat it.

  86. Hi, I have a study (contained in the PM) in which only 2 versions of the same drug are being compared. The PM contains baseline and last visit levels of an endpoint marker for both drugs. In a branded detail aid, am I allowed to show a graph (baseline vs. last visit) for just one of the drugs? Or do I have to show the same type of baseline vs. last visit graph for both drugs? Thanks!

    This type of question is best answered during the review or prior to it in the context of an opinion submission. In general, the efficacy results of a controlled trial are only interpretable in the context of both the treatment arm and the control arm (along with the corresponding statistical significance). Based on the limited info I have about your scenario, I'd have to advise reflect the PM (i.e. show both versions with the corresponding stats).

  87. Hi Patrick! We're looking to collect data from a patient survey related to dosage and administration. Ultimately, we would like to disseminate this information to HCPs so they are more aware of their patient behaviour and preferences in relation to their treatment. Could you suggest a way we would be able to do this? Thanks

    I'd like to provide a useful response. But doing so would require me to get more information. Please call me at 905-509-2275 to discuss.

  88. We are considering a partnership that will allow us to place unbranded, disease awareness information into a variety of large public health portals. The portals contain disease awareness information but also have separate areas that disseminate drug specific information. (We are not providing any drug specific information.) As part of this partnership, we are being offered the ability to have banner ads run throughout the site. The ads are not just for our unbranded content. There is the potential for us to have branded ads that point to our gated product-specific website. The banner ads are "run of site" and there is no influence on where they appear within the portal. There are two possible situations that we are concerned about.
    1. Our branded ad appears on a page where our unbranded disease information resides through random placement.
    2. Our unbranded disease awareness ad lands on a page which contains related drug information through random placement.

    These situations are out of control but may occur. Does this make us out of compliance with the spirit of the DTC advertising code?

    Generally, in a run of site context, those linkages should occur very rarely in a large/diverse portal (or sets of portals). The same random incidents occasionally occur in print publications. The core principle is that the manufacturer (or its agent) should not take steps to influence the ad environment in such a way that promotes the general public's ability to associate the product with its therapeutic use. Unlikely random incidents which are not under the manufacturer's or agent's control are unlikely to cause the manufacturer to be non-compliant with the consumer advertising regulations. For example, from a statistical perspective, the Arbace ad will appear much more frequently with unrelated condition content (e.g. mood disorders, erectile dysfunction, menopause, pain...etc.) than with disease content relating to its indication (i.e. hypertension).

    Having said this, these electronic portals provide the opportunity to set exceptions to the run of site command. For example, in my Arbace example, it is simple to allow for run of site except for pages containing the keyword hypertension. Many clients are doing this as a best-practice to make sure their advertising does not contravene (or appear to contravene) the regulations.

  89. In the new PAAB code, it says: "The PAAB can allow the use of observational studies when specific acceptance criteria are met." What are the specific acceptance criteria? Also, does a natural history study fall under an 'observational study' or 'meta-analysis'? Thanks

    A natural history study is a type of observational study which simply follows a group of people (e.g. on a drug or having a condition) over time. They tend not to have a control group and thus would not be considered as evidentiary support for claims in drug advertising.

    A high quality controlled cohort study or case-control study can be considered as evidence for adherence claims. These two groups of non-experimental trials can also be considered corroborating evidence for therapeutic claims of efficacy and safety. The guidance document on our website provides more information on observational studies.

    For any analysis (including observational studies and meta-analyses) "high quality" means that adequate steps were taken to ensure that the observations are not due to random luck or systematic bias (whether methodological or confounding). This can only be assessed if the study report is comprehensive. For observational studies we look to the STROBE checklist, for meta-analysis we look to the PRISMA checklist. These checklists do not tell you whether a study is high-quality, but they do tell you what parameters one needs to know in order to make that assessment.

  90. Please confirm the approval process for French websites. We submit the English copydecks and layouts for approvals. Once approved, we then submit the French copydecks for approval. Does the French copydeck require French layouts or can we submit the French copydeck with the English layout?

    It is sufficient to submit the French copydeck with the English layout.

  91. Is including the names of Rx products on sales rep business cards and email signatures allowed ? Or are these considered APS or potentially DTC advertising . Thank you

    It appears that there is a chance that these cards will fall into the hands of consumers. We must therefore consider consumer regulations. The name of the drug alone would not exceed consumer regulations (provided the drug is not a narcotic or a controlled drug as consumer promotion of such products is completely prohibited). However, inclusion of anything which would allude to the therapeutic use of the listed drug (e.g. a drug rep title such as "Neuroscience Specialty Mood Representative") would exceed consumer restrictions for prescription products and for products used for the treatment of a schedule A disease. It is advisable to limit distribution to HCPs if including anything beyond the company name/address, the drug rep name & contact info, and a generic title such as "Product Representative". Should distribution be limited to HCPs as they contained specific drug rep types, PAAB would review these as corporate pieces with product mention. All cards across the company's product offerings may be submitted as a single piece. For each product we'd ensure the implied therapeutic classification is accurate and on-label. Note that inclusion of product claims would require fair balance.

  92. Dear Concern, What are the time lines and submission procedures in canada. what are the guidelines for OTS products in health canada (submission only)

    The following response was drafted by our file coordinators. Please contact Laurie or Sabrina at the PAAB office if you have any questions. Submissions which require full review will receive a first response within 10 business days. Direct to Consumer pieces and Opinion requests receive a first response within 4 business days. Subsequent responses will be received in 3 business days.

    You may submit to PAAB for review, finalized copydeck or layout for the initial review, copydeck to be followed by a final layout prior to approval of an advertising piece. Please include the most recent product monograph and the Health Canada approved letter which supports this monograph. All references should be uploaded to the electronic submission and cross referenced on the copydeck or layout in a manner directing us precisely to the support for each claim. Responses will be emailed to the current email address that we have for your personal registration within the efile system. The final approval letter will contain your PAAB acceptance ID # for future reference. An invoice initiated at the time that the first response has been sent to you. For a more detailed explanation of the submission procedures, please refer to the Submissions Guidance Document on our website.

  93. In an APS for a prescription product, if you want to present side-by-side comparisons of non-therapeutic information from Product Monographs (e.g., product properties, use limitations) as per section 5.10.2, do you need to include all of the approved products in that indication or is it acceptable to show only selected products (e.g., two out of five available agents)? If all products must be mentioned, does that also include generics or only branded products? Thanks!

    In side-by-side comparisons of non-therapeutic information from Product Monographs, it is not necessary to include all comparators with the same indication. The comparison should be representative of the section of the Product Monograph that it is based on and should not be selective as to which attributes are included.

  94. Assuming you can ensure that your web platform is only being accessed by Canadian physicians, what are the rules about the content that is on the website? Does the fact that the physician agrees to be "subscribe" open a channel to the information being PAAB exempt on the premise that the physician "Requested" this information? We are thinking of CME materials, disease-relation information (with and without drug mentions), videos of speaker conferences, etc.) We are also thinking of information about the sponsor's ongoing clinical trials.

    I am not sure I fully understand the question. Please call me if I am off topic. Information provided to an individual in response to a request for information that has not been solicited in any way is not considered to be advertising for the sale of a drug and is therefore exempt from PAAB review. This specific exemption applies only when the information provided is limited specifically to that content which was requested by the HCP. Note that the mechanism for requesting this content and the mechanism for receiving it must be kept completely separate from drug advertising. For any information other than that which was explicitly requested, one must assess whether the drug advertising regulations apply by using the Health Canada policy document “The Distinction Between Advertising and Other Activities”. If the advertising regulations apply, the content should be submitted for PAAB review. Also see PAAB code section 6.6.

  95. If you recorded a speaker event (sponsored dinner conference) and want to post it on a website, can you? What rules is the content subject to and what is acceptable in terms of efforts or means by which you would make HCPs aware of the availability of this recorded presentation?

    If the content is advertising once posted on the website, it requires PAAB review. Please refer to the Health Canada guidance document "The Distinction Between Advertising and Other Activities" to determine whether it is advertising. Note that we'd require a copydeck for a formal review to approval. If you are uncertain whether it falls in the advertising realm, feel free to ask us by using our written opinion service (i.e. provide the content and clarify the context in which it will be posted). Refer to the fee schedule on PAAB website.

    Here are some examples:

    • If either the website or the recorded event emphasizes or favours the sponsor's product, the recording will be reviewed as a product branded APS (e.g. disease information posted on a product website is reviewed in the context of the brand).
    • If neither the website nor the recorded event emphasize/favour the sponsor's but they discuss issues relating to drug therapy, the recording will be reviewed as an editorial APS.
    • Disease information with no mention of drug therapy or even issues relating to drug therapy placed on a corporate website in a manner which does not link to a product in any way would be exempt from PAAB review.
  96. We have prepared a Patient Tear Off Sheet for Product X which provides information on the indication, dosing/administration, side effects, talk to your doctor immediately if you have x,y and z and interactions with drugs. My question is with respect to "Product X may interact with drugs to treat: Chest pain, angina (e.g. amyl nitrate "poppers") HIV infections (e.g. indinavir or itraconazole) Fungal infections (e.g. ketoconazole or itraconazole) Infections (e.g. gatifloxacin) Irregular heartbeat (e.g. amiodarone, sotalol, quinidine, procainamide) Prostate problems or high blood pressue (e.g. alpha-blockers). I would like to propose a change to Infections (in the list above) to replace "e.g. gatifloxacin" with "e.g. erythromycin and chlarithromycin" because these latter 2 drugs are contraindicated with use with product X (and are missing from the list)...and because gatifloxacin 400 mg is no longer available in Canada. There is a 0.3% gatifloxicin eye-drop solution available in Canada but it has no clinical bearing on the drug-drug interactions that were investigated with Product X. Note that the 0.3% gatifloxacin eye drop solution is not mentioned in the current approved Label for Product X. Only the 400 mg gatifloxacin is mentioned in Part 1/2 of the Product Monograph under Warnings/Precations, Drug-Interactions and Detailed Pharmacology. Health Canada did not inform us of the removal of 400 mg gatifloxacin product...and we have only just stumbled upon gatifloxacin in Section 3 of the PM (which states: Drugs that may interact with Product X include - gatifloxacin (used to treat infections). We propose to revise this statement in the product label with Health Canada. If this tear off sheet is intended to provide relevant patient information, would it be OK to replace "gatifloxacin" with "erythromycin and chlarithromycin". Or does "gatifloxacin" need to remain in this list...and "erythromycin and clarithromycin" be added too. Looking forward to your response. Thank you.

    There is generally no need to disclose risks relating to concomitant use with particular products which have been completely withdrawn from the Canadian market. BUT the fact that the specific agent, gatifloxacin, is presented as an example denotes that the risk extends to other drugs used to treat infections. It is therefore clear that the risk relating to concomitant use with drugs used to treat infections must still be conveyed in some manner (albeit not necessarily by including “gatifloxacin” as the example). Assessment of the complete monograph typically reveals signals indicating which agents could be used as examples in place of the withdrawn product. It is possible that your proposed plan is workable, but this could only be confirmed after assessment of the complete product monograph in the context of the therapeutic area (and the corresponding current medical practice).

  97. I run a medical information line for patients and Healthcare providers for a pharma company. Do I need to either read or have on the front end recording the safety statement from the PI prior to speaking with the customer?

    Medical information lines for which individuals call to ask unsolicited questions do not fall under the scope of the PAAB.

  98. Hi, I will be following PAAB regulations to ensure that an unbranded disease information piece qualifies as being 'PAAB exempt'. I will also be submitting it to PAAB (simply to get a letter saying that it is PAAB exempt). Is it necessary that the review papers we are referencing DO NOT make mention of treatement options anywhere as well (even though our APS will not make mention of treatment options/categories)? Or is it ok if the review paper discusses treatments so long as we dont make mention of them in the APS?

    The primary purpose of the review paper should not be to discuss treatment options. If it is then the APS you create could be deemed "editorial" in nature and subject to PAAB review. What is your intent? You should try to find a reference that discusses the disease only, not focussed on treatments. It may be exempt if all the treatments are balanced, see the Health Canada document The DIstinction Between Advertising and Other Activities 'Consumer Brochure'.

  99. We are developing a patient-directed instructional guide on how to use an injectable medication. The format is a flip chart, with visual instructions on one side (for the patient), and more detailed instructions on the reverse side (for the nurse's eyes only). Given the new PAAB code, and the fact that this is a HCP-delivered patient APS based on Section III of the product monograph, would the lowest level of fair balance suffice?

    In this case, probably no. The HCP portion of the flip chart would be reviewed as an HCP piece, and therefore it would be required to meet the guidelines and restrictions for HCP material. The level of fair balance would be based on the content that is presented within the HCP portion of the piece. The PAAB guidance document "Guidance on base fair balance level selection and placement" provides a list of considerations when determining the appropriate level of fair balance. This document outlines the types of messages that are associated with each of the levels of fair balance. The HCP presentation (and weblink) should not be visible to the patient.

  100. With the PAAB Approval comes an expiry date....is it a requirement to have this expiry date printed on the final promotional piece along with the PAAB logo? Or is it optional?

    This is not a requirement.

  101. In the US, promotional materials may use the term "new" for a period of six months from the first date of marketing by the company. Does the PAAB code or guidances have a similar requirement? (been searching but not finding).

    Yes. PAAB code section 11 of the PAAB code states: Use of the word 'new' or statements implying "new" in advertising should be restricted to 1 year after initial marketing.

  102. If our company has materials we plan to have in market for June 2013, can we use the new format fair/balance or must we continue to use the current format until July 2013?

    The new fair balance format can be used. However, print materials may not replace the PAAB format PI with a URL to the product monograph until July 1st.

  103. Dear PAAB, We are developing a gated HCP website that requires the HCP to enter his/her license number to gain access to the site. Who provides the database of physician license numbers which our site will "ping" (cross-check against)? If it is an outside source/organization, is there any fee for this?
    With thanks.

    The key is to validate that these are indeed HCPs. This may be done by an outside organization (in which case there may be a fee associated with this) or the validation could be done within your organization if you can maintain a current database of physicians.

  104. Can you create a url for your brand, that will be a password protected site, with the brand name and indication statement in it. e.g., maxaltmigraine.ca. The homepage for the site will be available to the public.

    For a prescription product, the linkage of the therapeutic use in the URL and the brand on the landing page would exceed the consumer advertising restriction of name/price/quantity in the Food and Drug Regulations Section C. 01.044. This linkage would also not be appropriate for a non-prescription product indicated for the treatment of a schedule A disease as per section 3 of the Food and Drugs Act. For a product branded landing page, a simple solution is to use the URL www.productname.ca

  105. If a journal ad highlighting a product portfolio (and therefore, includes product logos)were to make the following statement, would it be considered a claim of merit, if non-specific to any one drug: "[Company] committed to gastrointestinal care for over 80 years." If so, would the lowest level of fair balance suffice, according to the new PAAB Code?

    Under the July 2013 PAAB code:
    A piece containing only product logos (without taglines or other explicit/implicit product messages) + the corporate message "[Company] committed to gastrointestinal care for over 80 years" would not require fair balance. The piece would be reviewed under section 7.4. A piece containing only a product claim of "10 years of experience" would require the lowest level fair balance.

  106. Please explain "Claims relating to PRO endpoints must appear clearly within the context of the Health Canada approved indication." Does this mean that data from PROs must be in the PM, or just that the PM must address the outcome being assessed (e.g. "Drug X treats condition Y, and the pain from condition Y", for the PRO of pain reduction).

    That specific provision is simply meant to convey the following: The relevant indicated use must either appear in the PRO claim or in the context leading into it. The overall message should convey that the PRO outcome is secondary to management of the indicated use (rather than a separate product use). For example, the journal ad headline "Product X demonstrated improved QOL versus placebo" should actually read "In the management of MDD, product X demonstrated improved QOL versus placebo". That provision should be interpreted in the context of all other relevant provisions. As an aside, note that acronyms should be defined.

  107. Funtions of paab.

    The PAAB's primary role is to ensure that healthcare product communication for prescription, non-prescription, biological, homeopathic and natural health products is accurate, balanced and evidence-based, and reflects current and best practice. The PAAB also monitors trends in health product advertising and promotion and adjusts its code and practices as required to fulfill its mandate. PAAB monitors healthcare product advertising directed to health care professionals as per PAAB code section 10. PAAB also adjudicates stage II complaints on healthcare product advertising directed to health care professionals as per PAAB code section 9.

    The scope of the PAAB includes promotional healthcare product communication for prescription, non-prescription, biological, homeopathic and natural health products to health care professionals in all media. PAAB also provides advisory comments on direct-to-consumer materials for prescription drugs. PAAB's Scope evolves with the regulatory framework.

    Please visit our website at www.paab.ca for more information and don't hesitate to call us at (905) 509-2275 if you have any questions. Also find us on LinkedIn, join the PAAB group and participate in the discussion!

  108. Has the PAAB ever considered a "priority review" stream, whereby Clients could receive a shorter initial review (3-5 days vs 10) for a higher fee ($1000, $2000, etc)? There are occasions where guaranteed expedited timing is vital, and this option would serve the industry while generating additional revenue for the PAAB. To restrict use, Submission Coordinators could limit Files to those of formulary/safety content, or those of shorter length.

    Yes. PAAB has considered this. You'll note that complexity of HCP advertising review is at the core of most concerns. But I'd like to raise an ethical concern first. Specifically, creation of two separate fee streams may accentuate imbalances in the market place (e.g. smaller manufacturers & agencies may find it harder to access the priority stream due to budgetary reasons). Fairness is an important ingredient for a healthy preclearance system.

    I am uncertain what benefit the proposed system would have above and beyond the existing system if access to the priority stream was limited to APS which are simple and short. PAAB already does what it can to expedite such files when client expressed needs intersect with PAAB capacity to help. Under the proposed system, I suppose we'd need to ignore all requests for rushes in the regular stream as accommodating such requests would be unfair to those who paid extra for that privilege. This also leads to other interesting questions like "What happens when the regular fee stream is below day 10?"

    For example, I suspect it would appear unfair for your competitor to have received a day 6 response on the regular stream ($450) if you've paid $2000 to receive your response on day 5. It would be hard for clients to assess the cost-benefit of paying extra unless the size of the "benefit" was static/fixed. Would this mean that, when the priority fee was not paid, the PAAB could not respond until day 10 (even if the review was completed long before day 10)? Say the turnaround times were not static/fixed, wouldn't stakeholders come to suspect that reviews for the regular stream are intentionally slow so as to induce clients to pay the higher rate for the priority stream?

    In my experience, most projects are "priorities" by the time they are submitted for PAAB pre-clearance. The complexity of HCP advertising review would make it difficult to deliver on the priority commitment. This means that additional staff would be required (which further adds to complexity as the specific number of staff required would be difficult to forecast and the training period is such that it takes at least 6 months before new staff contribute in a meaningful way). If most projects go into the priority stream, the proposed structure essentially acts as a sizable fee hike. Note that a shortened first response time does not necessarily equate to a fast approval. Other key factors include how long revisions stay on the agency/manufacturer end before getting sent back to PAAB and how many rounds of revisions are required. Client efficiency is a key determinant of how long the file stays on the client end, while response quality is a key determinant of how many rounds of revisions are required to get to approval. Ultimately, it may be worthwhile for our clients to consider whether their interests are best served by investing in their own internal processes rather than the proposed system which essentially adds up to buying a few days on the PAAB end.

  109. Is PAAB planning to have another general meeting in Montreal on e-filing procedure? I was not able to attend the Feb course. Please advise asap. Thank you.

    Unless we have at least 30 attendees it is not cost effective to conduct an open course outside the PAAB office. We are going to develop a webinar in the near future. Stay tuned.

  110. A company is considering a patient support program. Before proceeding, they wish to conduct a pilot program that has been designed by an expert steering committee of specialists in the therapeutic area. Informed consent would be required from patients and the treating physician would give the information to the patient. During the course of treatment, the patient consent would include an agreement to be contacted by a PIPEDA-compliant CRO to collect information regarding the relative utility of the patient materials. The data would then be used to create the final program. The question is do the materials provided during the pilot stage need to be cleared by PAAB? It is understood that the final materials would be submitted to PAAB. Thank you for the opportunity to present this via the site. Excellent feature.

    I'll assume that the a pilot is intended simply to evaluate the program's impact, benefits and weaknesses before implementation. I'll also assume that good market research practices will be followed.

    A pilot should not be intended to promote the sale or disposal of medication. In that vein, it must have a small controlled scale (e.g. short term & low number of test cases). Provided the size and duration are the minimum required to contemplate the program, the pilot does not require review. Long duration or large scale may render the pilot promotional (thus disqualifying it from preclearance exemption).

    Note that the program will require review if the decision is made to implement it. Even when the pilot does not require review, it is advisable to submit it for pre-clearance if you are concerned about consistency of message between the pilot and implemented program. The pilot may have little value in predicting impact/benefits/weaknesses if it is significantly different from the eventual approved/implemented program.

  111. I understand there is a PAAB webinar about recent changes on Thursday, 21 Feb 2013 at 10:00 AM. How can I participate?

    The link to the registration page is at the extreme bottom of the following webpage: http://www.paab.ca/events/#newpaab

  112. Are there any guidelines (outside of color preference) for placement of the PAAB logo on an approved piece? Is there a size limitation of the logo or a desired location (front vs. back side) we should consider? The website is not loading the PAAB logosheet PDF unfortunately?

    Currently, the PAAB logo must appear in both the display and PI sections of the advertisements as per PAAB code section 8.5(b). After the PAAB code change, the logo need only appear on the display section of the advertisement. The code is not prescriptive with respect to placement and size. The manufacturer should ensure that the logo is easily identifiable.

    The logo is available at the following web-link: http://www.paab.ca/paab-icons.htm

    I was able to open the logo/icon documents. The problem may have been temporary. Please call the PAAB office if you have any difficulty opening these documents.

  113. I am seeking clarification on the recent PAAB advisory Jan 10 2013. If the "Now on Formulary" has codes which we include in the announcement is this still exempt? Secondly if we include codes and incluson criteria is this exempt. Thirdly if not exempt, do we then have to have full PI accompany the Ad. The latter adds significant cost to a relatively simple message. Finally is the inclusion of details on the special authorization or codes mandatory? It would appear from your memo it is at the discretion of the company? Thank you.

    PAAB Code section 2.1 states that advertising material must be accurate, complete and clear and designed to promote credibility and trust. We've been informed by provincial bodies that a formulary message containing coverage codes without also stating the covered use is incomplete and therefore violates the spirit of PAAB code section 2.1.

    Promotion of coverage codes must be accompanied with complete presentation of the corresponding coverage criteria. This means that when the coverage has limitations/exceptions, the manufacturer has the discretion to choose one of the following alternatives:

    • Simply state "Now on formulary (special authorization)" without mention of the formulary code(s). Presentation of this statement alone, in a manner which is not linked to a therapeutic message in any way, would be exempt from preclearance as per PAAB code section 6.6.
    • A message that includes the formulary code(s) such as "Now on formulary (special authorization Code 123)" requires inclusion of the corresponding coverage criteria, fair balance and PI. It therefore also requires PAAB review. Note that the coverage criteria may appear in a footnote on the same page as the coverage codes.

    Note: ALL post-approval changes involving the addition or modification of ANY formulary statements must be submitted for review as new files complete with the formulary references. Such post-approval changes are not accepted as FYI's.

  114. Would a natural OTC Supplement (no DIN number) require PAAB approval for promotional materials targeted to HCPs? Would consumer advertising require PAAB and/or ASC?

    Per PAAB code section 11.3(a), APS promoting supplements purely for the maintenance of normal health do not require PAAB review. Note that APS directed to healthcare professionals (or patients through healthcare professionals) relating to DIN, NPN, and DIN-HM products for more specific uses require PAAB review. For example, APS which promote the use of a Vitamin supplement for maintenance of strong bones would require PAAB review.

  115. Is there a ratio needed between the graphic display (image) and the monograph font size?

    Please see answer #92.

  116. Can a representative hand out a reprint in its entirety to an MD. The reprint is not marked up or highlighted and is within indication?

    The answer is yes when the study is consistent with the terms of market authorization and adequately designed (e.g. head-to-head randomised and controlled trial for active comparators). The key role of drug representatives is to promote the sale of the healthcare product. They should not be given off-label reprints or comparative studies that are poorly designed even if the documents are unchanged. For your convenience, the relevant section of the Health Canada policy document “The Distinction Between Advertising and Other Activities” follows:

    • Dissemination of full, unedited reference texts (textbooks, chapters of textbooks), government publications or reprints of published, peer-reviewed articles from medical or scientific journals, that are identified as being provided courtesy of a pharmaceutical manufacturer, may be a nonpromotional activity provided that:

      • no link between the text and promotion of a drug is established by the manufacturer.

      Such material may be considered to be advertising where the aforementioned condition is not met or where other factors indicate that the primary purpose is to promote the sale of a drug, for example:

      • the material is accompanied by any form of additional information (e.g., printed, word of mouth) designed by or on behalf of the manufacturer for the purpose of promoting a drug (e.g., detail aid),
      • the material was written or edited by an employee or agent of the pharmaceutical manufacturer,
      • a summary or interpretation of the text prepared by the pharmaceutical manufacturer or his agent accompanies the material,
      • reference is made to the availability of an unauthorized drug through the Special Access Programme.
  117. I'm curious as to why the STI Innovicares program is allowed to advertise specific brand name drugs on a website without PAAB review; especially given two main pharmaceutical companies are behind a large promotion of their brands (AZ/Sanofi)? Isn't this considered DTC advertising linked to brand name drugs? The website is at www.innovicares.ca and also has DTC ads and posters in addition to the website.

    I have not reviewed the site as this is a forum for Q&A on the general meaning and application of the PAAB Code of Advertising Acceptance and not for advertising monitoring, reviews, or complaints. You may call me if you have questions about whether specific content on publicly accessible portions of the site exceed this restriction. As a general point, promotion of Rx drugs to consumers is permitted, but it is restricted to name, price, and quantity. You may call me if you have questions about whether specific content on publicly accessible portions of the site exceed this restriction. Note that Health Canada adjudicates complaints about DTC advertising of healthcare products.

  118. Are there restrictions on the use of the Australian flag in advertising?

    Assuming you are referring to Canadian drug advertising directed to HCPs, as in many situations, context would be important in determining the acceptability of the proposed image. Feel free to call the PAAB office to discuss your scenario. We are here to help.

  119. Do they have a PAAB expiration of 1 year (i..e, do we need to renew annually)?

    Yes. Here is an excerpt from the October 2010 PAAB Newsletter (at that time called the "PAAB Review"): "We encourage you to show the PAAB logo on all material reviewed to acceptance (HP) or to no objection (DTC). The new DTC codes are CA for advertising and CI for information. The clearance period is for 12 months and please submit a renewal request if you wish to use the advertising for longer than 2 months. Two month extensions for exceptional circumstances can be granted by the commissioner".

  120. The Code (in part) states:
    1. that patient information is exempt from PAAB review if the information is direct from and consistent with the product monograph.
    2. patient materials must be non-promotional.

    The questions,

    • if by PAAB's interpretation, would the content of PART III of a product monograph be exempt if produced in a multipage brochure layout, accompanied by product branding elements (colors, graphic design, brand logo, etc).
    • if a brochure layout is acceptable, then may the formatting be comparable, or are there restrictions or requirements related to formatting treatments for section titles, italics, bolded fonts, underlined text, etc.

    Distribution of part III of the PM would not require PAAB preclearance.

    Modification (e.g. removal of content, insertion of text/visuals) made to the document for distribution to patients through HCPs would require PAAB even if the resulting document meets the PAAB code 6.4.3 requirements for consistency with part III & non-promotional content/tone. Indeed, PAAB pre-clearance is intended to ensure that these requirements are met. Call me at the PAAB office if you'd like to discuss your specific case.

  121. In addition to the automatic renewal email I just submitted, it would be AMAZING if the final PAAB approval letter (or final communication letter -- for both languages if applicable) was included in the eFile library along with the historical files. There is so much turnover in agencies, it would be incredibly helpful to have a complete document history in one location to help alleviate anything slipping through the cracks.

    I've forwarded your suggestion to Glenn Golaz. Thanks.

  122. This isn't really a question, but it would be great if PAAB were able to send an automatic email out 2 months before expiry on electronic media/websites. I am sure this is an easy thing to tag to the submission database and would be of great value to agencies and clients. Perhaps it is something that users can opt in to if there are any concerns. I hope you will consider this.

    Thanks for the suggestion. We did once consider this, but there are currently companies which provide this service. As an aside, we will soon be embarking on the process of revamping our electronic filing system.

    Suggestions are always welcome, but now they'd also be particularly timely. Don't hesitate to send your eFile system suggestions to Glenn Golaz at glenng@paab.ca.

  123. Is it acceptable to have a multiple choice practitioner-poll if the statements are not in any way therapeutic claims? The data collected is presented but will not be utilized in claims.

    Your non-therapeutic polling questions can be considered provided they are non-comparative. The polling questions would obviously need to be reviewed against all provisions of the PAAB code (e.g. consistency with TMA, validity of evidence, etc.).

  124. Could we use global data to support a worldwide market share claim which would include Canada? or is this something that can be confirmed by the sponsor's Med/Reg Department e.g. Drug X: Over 1.5 million patients worldwide.

    Non-comparative experience claims relating to # of patients (or patient years) can be supported by either by providing worldwide/Canadian data or by providing a letter from the sponsor's med/reg department confirming the claim. However, market share claims (such as #1 dispensed...) require independent data (e.g. from IMS/Brogan) which meet the market share guidelines which can be found on the PAAB website.

  125. Are unbranded printed materials focussing on disease area with no mention of drug treatments and that are presented to Health Care Professionals by Sales Representatives exempt from PAAB review?

    It is exempt if ALL of the following are true:

    • there is no mention of healthcare products (by name, class, or category)
    • no drug issues are discussed (e.g. adherence, side effects...)
    • no linkage of any kind to drug therapy

    It is not exempt from PAAB review if one of these is not true.

  126. It seems to be standard industry practice to post the Product Monographs for pharmaceutical drug products on the corporate websites. There are no ancillary messages provided with these, just the links to the full texts of the product monographs. In addition, these PMs are available through Health Canada's Drug Product Database to anyone who searches, and these are unrestricted. However, I understand that PAAB reviews company prepared websites specific to products, even if they only contain information straight from the PM without any editing. If it is okay to post the PMs on the corporate websites and other publically available portals, why do the designated product websites that only contain the PM information require PAAB review? Thanks!

    The unchanged product monograph on a corporate website is not considered advertising (provided of course there is no link to product promotion/advertising). In my experience, there would be little reason to create a stand-alone website for an unchanged monograph. In the context of a stand-alone product site, we are inherently promoting a product (would require gating). The landing is inherently promotional (within name, price and quantity of course). Besides, why create a website for something that is already on your corporate website. Something does not add up here. Call me if I've misunderstood your question.

    1. Is there a preference as to which comes first after a claim: the symbol (e.g. *) or the footnote number (e.g. 1)? "My product was tested and found to work."*1 or "My product was tested and found to work.1*
    2. Should these be superscripted or just keyed in in a regular font (e.g. *)
    3. Is there a separation required between footnote numbers and symbols? "My product was tested and found to work."1,*

    In AMA (American Medical Association) format the reference number would come first, separated by a comma, then the footnote symbol. The referencing would be superscripted. "My product was tested and found to work." 1,*

    For the PAAB submissions requirement for referencing advertising claim in an Advertising/Promotion System (APS), each claim or presentation would need to be accompanied by clear identification of the reference source as well as the relevant section and page number within the reference source where the claim is located. Additionally, the referencing copy should appear in a different colour from the advertising copy, and the corresponding section of the reference source highlighted and labeled. As an example: "My product was tested and found to work." 1,* [Ref 1A, p.50].

    In this example Ref 1 - refers to the reference number, A – refers to the section of the reference where the claim is located, and p.50 refers to the page number of the reference source where the claim is located. The choice to include the AMA format in addition to the PAAB APS submissions requirement format is optional.

  127. If a product has multiple indications, but we are developing a promotional piece for just one of those indications, does the fair balance copy still have to contain all indications and balance copy for ALL the indications? Thank you.

    No. The piece need only contain the indications relating to the promoted uses. Note that some claims promote all indications (thus requiring presentation of all indications). An example that comes to mind is "Product X has 3 indications" (i.e. the 3 indication would appear in proximity to the claim). If the claims truly relate only to the one indication per your question, that is the only indication which is required to be presented.

  128. If we were to develop an unbranded DTC help-seeking ad (in which the pharmaceutical sponsor WOULD NOT be disclosed) - can the ad link to a DTC, disease-state website, in which the pharmaceutical sponsor IS disclosed? The disease-state website has been previously approved by PAAB.

    A tool meeting all the requirements of a Help-seeking announcement from the Health Canada policy document "The Distinction Between Advertising and Other Activities" (e.g. no mention of the company name or product) may direct patients to a web consumer brochure meeting all the requirements of that same Health Canada document. A consumer brochure may mention the company name.

  129. When PAAB approves a submitted piece, it provides an approval identification number. Can you advise me as to the configuration of that number? How many characters is it? Is it an alpha-numeric configuration? We are formatting a cloud-based internal review system and would like to capture our PAAB approvals accordingly. Thank you.

    Currently, our PAAB Approval Acceptance number consists of a maximum of 33 characters, not including the ID# preface, and is alpha-numeric in configuration with symbols.

    Please see the example below for the configuration and explanation of each part making up the Acceptance number.

    ID# PAAB/12345/D/E&F/11-2012-10-2013


    ID# is the preface for the actual Acceptance number and is not included in the character count of 33.

    PAAB is static within the acceptance number

    12345 signifies the corresponding eFile number for the submission. The character # in this field will increase over time as the number of submissions to PAAB increases.

    D signifies the Prescribing Information status for the submission.

      D is for Disclosure (Branded pieces and Prescribing Information)
      R is for Reminder (Reminder advertising pieces)
      E is for Editorial (Editorial advertising pieces)
      I is for Institutional ( Institutional advertising pieces)
      CI is for Consumer Information (DTC information pieces)
      CA is for Consumer Advertising (DTC advertising pieces)

    E&F signifies the language in which the advertising piece has been approved. This character field may vary as some advertising pieces are approved in English or French [] therefore, this field will simply list the corresponding language letter equivalent E or F.

    11-2012-10-2013 signifies the PAAB Acceptance Period. The # of characters in this field remains static as single digit months in the calendar are identified with a ‘0’ in front of the numerical value for that month. Eg. 01-2012-12-2012. The first month and year listed in this field indicates the start date of the Acceptance period and the second month and year listed indicates the expiry of the Acceptance period. In this example, the Acceptance period starts on the first day of November 2012 and it expires on the last day of October 2013.

    I hope that I have answered all of your questions. Please feel free to contact me if you have further questions.

  130. Hi, I was told that an unbranded piece that would be in a waiting room would be direct to consumer, and those which would be in the doctors office are direct to patient. Is this correct?? IF SO, then what are the differences in terms of regulations? For example, what can be said in an unbranded piece in a waiting room that cannot be said in a piece designed for the doctor's office?

    In short, PAAB code section 6.4 applies to all materials destined for clinics that will be used by (or go through) health professionals. PAAB will layer the Health Canada policy document "The Distinction Between Advertising and Other Activities" onto the review for items which will be openly visible (whether in the waiting room or the examination room).

    Let's now dive into the specifics relating to the "why" and the "how". The HCP is involved in the decision to place these materials in the examination room and they use these items in patient counselling. These materials are therefore regarded as having, in addition to the primary audiences of the HCP and the patient, a secondary audience - the healthcare consumer. Consequently, these APS are subject to the applicable sections of the Food and Drugs Act and Regulations, policy and guidance documents pertaining to advertising, and the PAAB Code.

    Please keep the following in mind for materials openly visible to healthcare consumers within HCP-patient interaction areas (the first 2 bullets relate to your question):

    • Help-seeking announcements must follow the guidance within the Health Canada policy document "The Distinction Between Advertising and Other activities" (e.g. may not disclose the product name or manufacturer's name).
    • Non-product branded examination room posters describing the disease area and therapeutic landscape must follow the guidance for consumer brochures within the policy document "The Distinction Between Advertising and Other activities".
    • Product-branded APS for a prescription drug (Schedule F) must be limited to name, price and quantity as per Section C.01.044 of the Regulations. This limitation does not apply to nonprescription drugs and natural health products (NHPs); however, the schedule A prohibitions discussed below must be considered.
    • Product-branded APS for a prescription or nonprescription product may not discuss the treatment or cure of any Schedule A disease (Section 3 of the Act). Note that section A.01.067 added to the regulations on June 1, 2008 permits nonprescription products and NHPs indicated for the prevention of diseases listed on schedule A to make preventative claims.

    In addition to considering PAAB code section 6.4 for all these tools, it is also important to consider PAAB code section 2.5. For example, the CMA has requested that PAAB ensures that images portrayed in APS reflect lifestyle best practices (e.g. helmets on bicyclists, life preservers on people in a small boat/raft).

    The regulations are similar for the tools displayed in the waiting room. Keep in mind that tools intended for the waiting room sometimes migrate into the examination room (and vice versa).

  131. Hi, Could you please tell me if you can just have fair balance on a branded reprint carrier or do you need the prescribing summary? Is it necessary not have anything if you are not leaving it behind. Thank you!

    The prescribing summary is needed if the tool is left behind with the HCP.
    In these cases, it is sufficient for the prescribing summary to be included as one of the inserts in the carrier.
    If the carrier will not be left behind, the prescribing summary is not required. In these cases, it is sufficient for the drug rep to have the product monograph on hand in case the HCP asks to refer to it during the visit.

  132. Hi PAAB: Educational material on disease state is being put together in an APS for doctors to distribute to appropriate patients, after the doctor has educated the patient on the disease state. The doctor will provide the handouts to the patients at his/her discretion. Is inclusion of a branded section on how to use the product allowable for this APS?

    If the intent is for product branded content to be distributed with the disease state piece, then the PAAB should be asked to review the disease state piece in a product branded context. The answer is yes only when this is done. The principle outlined in Q&A 232 applies to patient information as well.

  133. Hi! Do PI updates need to be submitted to PAAB or is it ok if they are just sent as an FYI to a previously approved PI update. Please advise. Thanks.

    The PAAB only reviews the PI format. As such only changes in format require resubmission. Content updates should be provided as FYIs.

  134. I am working on an unbranded piece speaking to medication adherence in general. Can I put product logos (without indication or claims) on it if the content does not cover indications or treatment in any way?

    No. Such linkage would suggest that the drug somehow addresses the issue of adherence. Linking product X to disease information about adherence would therefore require insertion of Product X adherence data. This would also require insertion of the product indication and fair balance.

  135. Dear PAAB: We have both unbranded and branded APS approved by PAAB. What are suggested and appropriate mechanisms for unbranded (HCP:patient teaching tools) and branded APS to be distributed by sales representatives, so as to not create linkage between the pieces? Are separate calls (branded and unbranded) appropriate? Is distribution of the unbranded APS (i.e. by request form, business reply card etc.) with follow-up by the sales representative specifically to discuss the unbranded APS, an acceptable way to separate the pieces?

    Yes and yes respectively. For more information see Q&A # 232.

  136. Can a company display disease state educational materials at a booth at a conference in which the company does not have any marketed compounds (i.e. a disease awareness booth)?

    Yes. BUT it is critical to restrict the content to disease information in a manner which neither refers to nor alludes to the unapproved product. Even indirect promotion of an unapproved product could contravene section C.08 002 of the Food and Drug Regulations.

  137. Cosmetics are not in the scope of the PAAB code unless they are medicated or hypoallergenic. I assume that any medicated have a DIN or NPN.

    Is this also true of products with a hypoallergenic claim? We have a Cosmetic (no DIN, no NPN)in our portfolio that the company wants to detail to HCP. As such, HCP specifc promotional material is being created. Despite the fact that cosmetics without a DIN or NHP are outside the scope of PAAB, does the fact that the promotional material is directed to HCP mean it should be reviewed by PAAB or would this still fall under ASC? Thank you for your assistance.

    For the purpose of the PAAB Code, cosmetics (as defined in the Food and Drugs Act and Regulations) are excluded from the definition of "Healthcare Product" and therefore do not fall within the scope of PAAB preclearance.

    See PAAB code section 11.3(a). Therapeutic claims cannot be made for such cosmetics AND all cosmetic claims should be aligned with the Health Canada guidance document " Guidelines for Cosmetic Advertising and Labelling Claims".

    Note that therapeutic cosmetics, e.g. medicated and hypoallergenic preparations, are classed as pharmaceutical products. Advertising/Promotion Systems (APS) for such products must be submitted for PAAB review and clearance.

  138. Are sales representatives are allowed to detail on unbranded disease messages, and product-specific messages for this disease in the same sales call, even if the messages are presented in separate APS? I'm concerned about the concept of linking unbranded messages to branded claims.

    I can see why you'd be concerned. This activity would inherently brand the non-branded piece through linkage. If the non-branded piece contains content which would not be accepted in a branded context, this activity would contravene the regs.

    Whenever linking separate materials/activities, always pause to examine whether the linkage would change the regulatory status of those materials.

  139. Is it permissible to advertise for sale NHP's or OTC's to the general public via such media as The Home Shopping Network? Are there any restriction that a distributor should be aware of?

    Advertising to the general public for NHP's and OTC's must meet the requirements outlined in the Health Canada policy document "Consumer Advertising Guidelines for Marketed Health Products (for Nonprescription Drugs including Natural Health Products)". Here is a link for your convenience: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/guide-ldir_consom_consum-eng.php

  140. Hello, I am developing a free iPad application that provides healthcare education presentations for HCPs only. This app will be available for download from Apple's app store. What kind of user gating am I required to have for this app? Is a disclaimer + check box certification of the HCP status enough? Furthermore, I have heard about new sections being implemented in the PAAB code that are related to this - possibly referred to as "access control". Do you have any information concerning these guidelines? Thank you!

    No, a disclaimer and a checkbox are not sufficient. Assuming that the content on the app exceeds that which is permissible within the consumer advertising regulations, you'll need a well-controlled entry system (i.e. some sort of gate which poses an effective barrier of entry for non-HCPs) .

    For apps, this is often done through a password entry mechanism which is encountered once the user tries to open the app (after having downloaded it on his/her device). In such cases, it is critical to ensure that the combined content prior to successful password entry (e.g. app name, keywords that generate the app name as a search result, content on app store description, user generated comments...) do not exceed the consumer regulations. Another option is to place the app download in a gated part of the pharma manufacturer's website (such that consumer regulations do not need to be considered in creating any post-gate app descriptions). In this scenario, we've seen and approved barriers requiring some sort of hardware (such as USB sticks) distributed in a controlled manner by the manufacturer, a password distributed in a controlled manner by the manufacturer, the HCP's license number, or a URL sent to the HCP through a targeted email.

  141. Our agency has always laid out Prescribing Information pages closely following the two-column format set out by PAAB a few years ago. I notice that some prescribing information pages now are in three columns (and otherwise seem to follow the font-size and headings guidelines set out).

    Shifting to a three-column format could save considerable space (especially in adverse events tables) and might reduce by one page our clients' number of Prescribing Info pages required. So if we submit a three-column version for review, and follow all the other rules, we will be likely get it accepted?

    The answer is "yes" as per the PI style on the PAAB website. It can be found at the following URL: http://www.paab.ca/resources/pdfs/Prescribing%20Information%20Style%20Guide.pdf.

  142. In reference to PAAB code section 6.3 Detail Aids (2nd paragraph):

    "Prescribing information should form an integral part of the presentation or be attached to it when the item is left with the health professional".

    Is it acceptable, for a sales representative to offer the HCP with an electronic copy of the Product Monograph (PM) rather than the hard copy? The PM (pdf copy) would be sent as an attachment by email to the HCP within the same visit the material is left behind. If an electronic copy is acceptable, could we also refer the HCP to a link (usually the website of the company) where to obtain the Product Monograph?

    Currently, the answers are "No" and "No" respectively. The PI must be accessible while the APS claims are being accessed. This is ensured by delivering the PI over the same type of media as the APS.

    Requirements relating to the PI are in the process of changing. Stay tuned...

  143. Just saw a tv ad on CANADIAN tv (Sportsnet) for zostavax, referring viewers to zostavax.ca and it very obviously promotes it for prevention of shingles. How is this not a violation of DTCA regs?

    This forum is intended for discussion relating to general application of the code and regulations. It is not intended for performing reviews of existing pieces. I have not seen the particular ad referred to in your question.

    Nonetheless, readers should note that it is permissible to discuss the therapeutic use of Schedule D products (such as vaccines) in DTC advertising IF fair balance is provided. You can refer to the Health Canada Interim Guidance "Fair Balance in Direct-to-Consumer Advertising of Vaccines".

  144. I have been contracted by CTC Communications to aid in developing an application program on a product for a chronic arthritic condition with a high indication of depression/anxiety in patients. Like most chronic illnesses, the incidence of a mood disorder is high - this has nothing to do with the drugs treating the arthritic condition (i.e. the drugs are not causing or treating the mood disorder). In this program, no claims are made regarding the product (i.e. no claims are made that the drug helps depression/anxiety), it simply offers education and rating scales on depression/anxiety. Does this program need to be PAAB approved? Furthermore, what elements of the program need to be passed through PAAB?

    The elements include:

    • Content in the application
    • Information handout on the application that the representative may leave with the physician
    • Paper or e-detail on the application that the representative may use to detail the physician on the application

    Thank you for your feedback in advance.

    This appears to be the same question as 224. Please see answer 224.

  145. Hello, I work for a medical communications agency. We were given a restricted educational grant to develop a program which falls under the category (as per Rx&D) 'Other Learning Program'. It follows the CME guidelines but is not accredited. The program sponsor did not have any involvement with the development of the program content. It was developed by the steering committee of specialists. The program is unbiased in nature.

    Treatment options for the condition in question are mentioned but not the drugs themselves. The distribution of the program will be via a direct mailer to the target audience that drives the audience to a web site where the program is housed - sales representatives are not involved in the distribution. Please confirm if this requires review/approval from PAAB.

    Based on the limited information you provided and the fact that we could not see the actual program, we provide the following guidance.

    Health Canada, the ultimate federal authority on advertising regulations, employs the Health Canada policy document "The Distinction Between Advertising and Other Activities" to distinguish between advertising and non-advertising. This policy document contains 7 factors which, when assessed objectively, help us determine whether the advertising regulations (including the PAAB code) apply to the materials in question. These factors relate to content, extent of influence, the audience, who delivers the message, whether it is sponsored, the message context, and frequency of distribution.

    This program appears to fall in the realm of HCP advertising (and thus requires PAAB review) as it exists due to pharma funding, it relates to drug therapy, it is disseminated to HCPs through a push system, AND the manufacturer appears to have had influence over the content or the creation process (as it was created through a restricted grant). Potential examples of influence include selection of the precise topic, scope of research, the committee members, writers and/or having review privileges. This document would be reviewed as an editorial under PAAB code section 7.6.

  146. I have been contracted by an agency to help develop a program for doctors on a product for an arthritic condition with a high indication of depression and anxiety in patients. No claims are made in the program regarding the drug. The program simply offers education and tools on depression and anxiety in these patients with this arthritic condition. What are the PAAB guidelines that must be adhered to in this program? Thanks!

    This sounds as though it is a product branded app. All PAAB code provisions would apply. For example, all content offered through the app (whether treatment or disease related) would need to be on-label for that product.

    It's hard to provide more specific information without seeing the specific APP. If you'd like to receive guidance before getting too far into the project, I suggest submitting what you are envisioning for a written PAAB opinion. This is a great way to learn about key red flags while you are still early in the process. The fee schedule for an opinion is on our website. Call the PAAB office and ask to speak with one of our file coordinators if you'd like information on how to submit a request for an opinion.

  147. Hi, In the past we produced a branded APS presenting ongoing off-label trials. This piece was reviewed and approved by PAAB. Recently, we looked at the PAAB code and found that mentions of ongoing trials were acceptable in a non-promotional context. We have 2 questions:
    1. Did the code change regarding the mention of ongoing trials?
    2. Can you describe or give an example of a non-promotional context (unbranded material?)?

    Thank you

    PAAB section 3.2.3 has not changed. It reads:

    "Reference to research or ongoing studies may be made in a nonpromotional context with no prominence on information that has not been authorized by Health Canada. A study involving off-label use, that has been completed or has been presented at a medical meeting, and includes information that is not included in the Health Canada Terms of Market Authorization, should not be mentioned in advertising".

    Ongoing trials may be discussed in branded APS in a context clearly conveying that the trials are “ongoing” (and clearly separated from completed studies so as not to confuse the reader). Mention of off-label endpoints should be disclaimed (e.g. “Arbace is not indicated to…”). The PAAB defines ongoing studies as studies which are still within the data gathering stage. It is important to note that once data gathering is complete, or an interim analysis is conducted, we no longer consider the study to be “ongoing” even if data has not been published or made public. The manufacturer must cease distribution of the piece once any of the included studies no longer meet these criteria (irrespective of the pre-clearance period within the PAAB approval number).

    The segment “in a non-promotional context” is meant to convey that the tone relating to ongoing study content within the APS must be non-promotional. For example, promotional elements should not be associated with the off-label ongoing studies (e.g. study taglines, or promotional buttons/visuals). Additionally, promotional adjectives such as “large scale”, “rigorous”, “landmark”, “pivotal” must not be used when describing such trials. The presentation should simply convey that the manufacturer is involved in research (+/- a description of that research).

    The anticipated completion date of the study may not be provided (as this alerts readers as to when to start looking for the study results). Additionally, an entire campaign based on off-label ongoing studies could be considered to be a violation as such activity could be construed as promotion off-label uses. We therefore advise our clients to exercise caution when considering the frequency of messaging and breadth of formats/media used to discuss ongoing studies.

  148. What are the restrictions regarding reporting on efficacy in a clinical trial in our news releases? We will be issuing a news release when we receive NOC. We want to say what improvement in patient health was observed in the trial. The trial compared our drug to placebo. How can we explain what happened?

    The Health Canada policy document "The Distinction Between Advertising and Other Activities" outlines the requirements for press releases not to fall in the realm of advertising regulations. I'd like to emphasize four provisions which appear to be particularly relevant to your question.

    The first three provisions centre on the principle of sticking to reporting the facts which are indeed "news":

    • There should be no statement made regarding the expected degree of safety or efficacy. In other words, limit the discussion to the fact that the study is now complete and the results which were demonstrated versus placebo in that particular study.
    • Aside from reporting the study results, the announcement should be limited to the name of the drug and its authorized/proposed therapeutic use. In other words there should be no speculation of what the drug's approval or the study's results could mean (e.g. this is a game changer), and no elaboration about previous studies on the sponsor's or competitor's drugs.
    • Nothing should imply that the product is a breakthrough.

    Additionally, note that a press release should contain no comparisons against other treatments (this should not be an issue in your case as you've noted that this is a placebo controlled study).

    Refer to the aforementioned policy for additional requirements relating to the intended audience, appropriate disclosure when the release relates to an unapproved product or unapproved indication, extent of influence on pick-up/visibility, and considerations for products on the Special Access Programme.

    Why is it so important that press releases be constructed so as NOT to fall in the realm of advertising regulations? For starters, they can be accessed by members of the general public while the content exceeds that which is permissible in the consumer advertising realm. Additionally, they tend to relate to unapproved products/uses (advertising of which contravenes section 9.1 of the Food and Drugs Act). Finally, as they focus on what is "new", they're unlikely to meet advertising requirements for disclosure of risk information.

  149. Reading Q&A section, I understand that advertising to HCPs, although voluntary, falls under PAAB. Where would we go to clear advertising to the consumer? I usually work with food, so it is new for me to work with NHPs and I would like to do this correctly. Thank you.

    Pre-clearance for healthcare professional (HCP) advertising of healthcare products is voluntary. However, some trade organizations require their members to participate in PAAB preclearance mechanism as a condition of membership. Also note that PAAB monitors the market place and intervenes in response to HCP advertising which does not meet the PAAB code requirements.

    In the interest of preserving self-regulation, we'll notify Health Canada when we encounter willful non-adherence to PAAB code provisions which relate to the Food and Drugs Act. The PAAB pre-clearance mechanism is the most effective way to ensure that advertising is consistent with the PAAB code.

    In response to your question, the PAAB code applies to healthcare professional advertising and patient information for all healthcare products (whether it be a natural health product, a homeopathic product, a biological, or a prescription product). Both the PAAB and ASC provide advisory opinions for direct to consumer advertising of prescription and biologic products. ASC and MIJO provide preclearance for consumer non-prescription and natural health product advertising.

  150. A couple colleagues have recently indicated that Annotated Product Monographs are beginning to be subjected to more stringent restrictions by the PAAB. Both indicated that the reason was that by calling out certain elements of the product monograph that it was creating "undue emphasis" on product attributes. This raises two questions:
    1. How does this differ from a typical sales aid whereby charts and compelling data points are given emphasis and fairly balanced with appropriate safety information, etc. AND
    2. Doesn't the fact that an annotated Product Monograph contains all pertinent balancing information in one easily accessible tool not by default ensure that appropriate caution was exercised in highlighting data?

    Furthermore, is this a recent development? I can recall within the last 2 years working on several of these tools with no such objections from the PAAB. Thanks in advance for your reply!

    PAAB has created a guideline document for annotated product monographs. It summarizes how PAAB has already been reviewing annotated product monographs. Rx&D is currently helping PAAB review the document. We have not added "increasingly stringent restrictions". You can still use callouts in the margins of the document (I assume this is what you are referring to ). Call me and we can talk about it.

  151. Hi Patrick. We're looking to place a card within packs of our prescription product, directing patients to our website. The card will contain no promotional claims. Only content would include: product and company name. Please go to www.xxxxxxxxxx.com Since the piece will essentially be part of the product packaging, I wanted to ask if this would fall under review of PAAB or HC? Also, as there are no product claims, would this be exempt from review? Thanks!

    Content placed in the product package should be sent to Health Canada for review. No PAAB preclearance is required for such content.

  152. Dear PAAB, We are interested in building a small electronic questionanire that reps will use to ask the doctors some questions about how they feel certain things are a problem in their practice when managing their XXX[disease state] patients? The questionnaire would be unbranded, make no mention of any treatments. Would this be considered PAAB exempt?

    Disease information materials which make no mention of treatment by name, class, or category AND are not linked to healthcare product advertising in any way are exempt from PAAB preclearance. If this accurately describes your questionnaire, it would be exempt from PAAB preclearance.
    Note that "disease information" would not include content alluding to drug treatment even if no product/class/category is mentioned. For example, a questionnaire containing questions like "Have you noticed that your patients have adherence issues with medications that are dosed more than once per day?" would not be exempt from PAAB preclearance.
    Although not directly related to your question, it should also be noted that market research materials meeting all provisions outlined in chapter 17 of the 2012 Rx&D code do not require PAAB review.

  153. We are holding a patient conference where there will be sponsoring companies exhibiting. Some are companies that have Rx products and some are companies with OTC products. What are the guidelines for the exhibitors in both cases? What are the limitations, in particular, for the Rx product companies with respect to promoting their therapeutic products? The audience is a mix of patients who have several different diseases, as well as the general public.

    The consumer advertising rules apply. With regards to promoting Rx products, the advertising is restricted to name, price, and quantity. Alternatively, the manufacturer can create information pieces which don't fall into the advertising realm (e.g. Consumer Brochures or Help Seeking Messages). Refer to the Health Canada policy document "The Distinction Between Advertising and Other Activities".
    When promoting OTC products to consumers, the product's therapeutic use can be promoted (provided the promoted indication does not relate to treatment of a schedule A disease). Please refer to the Health Canada policy document "Consumer Advertising Guidelines for Marketed Health Products (for Nonprescription Drugs including Natural Health Products)".

  154. Would a RX script pad require PAAB approval? The pad will contain taglines from a PAAB-approved ad. Thank you.

    PAAB pre-clearance requirements apply irrespective of the format/media. If it is drug advertising and it is directed to HCPs, it is PAABable. In your case, we would review the tagline in its current context. Note that fair balance requirements would apply. We'd also urge the manufacturer to ensure that distribution of this "Rx script pad" does not contravene the Rx&D code.
    PAAB does not adjudicate the Rx&D code but we are aware of prior rulings relating to Rx pads.

  155. Dear PAAB Can a sales rep distribute a patient booklet that has been independently created by patient group? Can they distribute the booklet if their company sponsored the creation of the booklet? Many thanks.

    I presume the booklet is distributed by reps to HCPs (and the HCPs then distribute to the patient). Reps should not be distributing content to patients. With this understanding, the answer is yes. BUT, please note that the piece requires PAAB review if the manufacturer had any influence over content creation. Examples of "influence" include (but are not limited to): detailed direction on content or scope of research, review privileges, selection of writer...

  156. Do the same rules apply to unbranded materials as branded? For example, Can I use review papers to discuss disease category education? What materials are acceptable to use as reference? Thank you!

    Editorials are reviewed under section 7.6 of the PAAB code. The PAAB code does not differentiate between branded and non-branded APS with regards to standards of evidence. The main difference between a branded and non-branded APS is that all content is inherently linked to the sponsor's product in a branded piece (this means that even non-drug content must fall within the limitations of the sponsor's product monograph). Review papers are not accepted to support drug claims. Review papers are only considered for disease information. The reference requirements depend on the claim type. This is not a "one or two paragrapher". We'll be discussing evidence standards in our October workshops. In the meanwhile, feel free to scan the Q&A category "Claims & support/references for claims" then either call the PAAB office to pose a quick general question or submit a request for a written opinion on your specific scenario (see PAAB website for fee schedule) if your question remains unanswered.

  157. Dear PAAB, I am curious about creating unbranded educational material around Subsequent Entry Biologics. We know that there are potentially alot of issues that SEBs can have considering the nature of the manufacturing process. Is it acceptable to educate physicians on the challenges, risks, and non-identical nature of SEBs vs. orignial product, using review and 'expert opinion' articles in an unbranded piece? Alternatively, if we had a study that was done that showed these issues would we be able to use that? Or is it, if Health Canada has approved it then we can't say anything to infer challenges and risks? Many thanks.

    The piece you have described would be reviewed as an editorial (i.e. "unbranded" piece) under PAAB code s7.6. As a general principle, advertising should promote the sponsor's product by its own merits rather than by calling attention to the limitations of competitors (whether perceived or factual). The hypothetical piece you are describing risks being disparaging. Clients are sometimes surprised to learn that "Factual" and "misleading" are not necessarily mutually exclusive.
    Also note that class/category claims are generally not accepted. Given the variability within any given product classes and categories, it is misleading to make sweeping class/category statements.
    Finally, drug claims should not be based on review papers or expert opinion. The opinions of an individual are not necessarily consistent with broader current medical opinion. Comparative efficacy and safety claims require double blinded head-to-head RCTs.

  158. Am I correct in reading that:
    • a reminder ad cannot be used for 2 years following introduction to Canadian market? (and then, only if no new serious events that warranted a warning letter from HC)
    • reminder ad is exempt from PAAB but must be submitted to HC as labeling?
    • ad must include where monograph/full PI may be obtained in Canada, the full name & address of manufacturer and any special restriction in use or distribution

    Healthcare professional targeted reminder ads:
    A and C are correct for healthcare professional reminder ads only. The complete list of requirements for HCP reminder ads can be found in the PAAB code section 7.4.
    B is incorrect. Healthcare professional reminder ads are not exempt from PAAB preclearance as they are required to meet the provisions in PAAB code section 7.4.

    Reminder ads open to the general public:
    For consumer reminder ads, the PAAB provides an advisory service. As per Food and Drug Regulation C.01.044, reminder ads that are open to the general public must not exceed name, price, and quantity and therefore should not be linked in anyway to messaging about the products therapeutic area (e.g. the ad is prohibited from including the monograph or PI). Unlike for HCP reminder ads, there is no restriction relating to how long the product has been available on the Canadian market or how recently a serious event warranted a letter from Health Canada.

  159. Since Jan 2009 Q&A, is there update further to question #84 on distribution of reprints and Health Canada/PAAB postiion?

    The answer to question #84 has not changed. Health Canada is ever vigilant of off-label promotion and unsolicited distribution of reprints by pharma reps is a tactic that can do that. Therefore, the PAAB advises companies to train their reps well and restrict the materials they hand out, to those that meet the requirements of the federal law and the PAAB Code of Advertising Acceptance.

  160. Would PAAB approval be required for cards containing the Ontario Drug Benefit (ODB) Reimbursement Codes for a drug class?
    • content is copied verbatim from the ODB website
    • OBD website/URL is referenced
    • no mention of drug name or drug logo
    • no mention of pharmaceutical company
    • to be distributed by drug rep

    Caution should be used when editing official government documents, which you are basically doing here. Context is important. You may want to seek permission from ODB to edit the information in the manner you are stating. The PAAB has received complaints from provinces about some marketing activities that included editing information or forms. If no drugs are mentioned, and the province has no objection, the item would not require PAAB review. It is better to hand out the entire published document, unedited.

  161. I work for a drug company and want to sponsor a grant for the Patient groups to reach out to patients to videotape their journey through their disease and experience with a new treatment they are on (our drug). We will be hands off for details and production of this video and it will be put on their site to share with other patients -- do we need to tell them to PAAB the video and are their any other requirements we need to follow? Can we also post a link to their site with the video? Thank you very much!

    Yes, the video should be reviewed by PAAB as it exists due to the sponsor's funding (i.e. not independent created) and it will focus on the sponsor's product. See PAAB code s6.6 (a). Assuming that this is a prescription product, note that the content on the website should be gated (i.e. the general public should not have access to the content as it will invariably exceed the name, price, and quantity restriction). The PAAB will review the patient content under PAAB section code 6.4.3. PAAB will also be reviewing the contexts in which you are linking to the video in other APS.

  162. Hi there I was wondering if we would need to PAAB-approval formulary announcements to physicians if conditions for benefit on the formulary in their province are to be listed in the announcement. Example for coverage on provincial plan:
    • Patients are over 4 years old
    • Cared by a physician experienced in managing seizures associated with LGS
    • Already on two or more antiepileptic drugs in whom topirimate, lamotrigine and other expensive drugs are ineffective or inappropriate.

    Thank you

    Yes. APS comprised of a formulary announcement which includes a conditions for benefit requires PAAB review. See question & answer 201.

  163. If only US data is available for a particular disease, is that acceptable by PAAB?

    In the absence of Canadian data for disease prevalence, PAAB will consider U.S. data providing it is a reasonable representation of the Canadian environment. An example where geography may differ significantly is microbial prevalence and susceptibility. PAAB will base its review of the data on the specific disease state. When deemed appropriate, the data should be based on recent authoritative consensus guidelines, recognized medical texts or primary epidemiology studies. The presentation of the data should clearly indicate the geographic location and date the data was obtained.

  164. Under what circumstances would it be acceptable to claim that two arms of a clinical trial have similar side effect profiles? Does it only relate to the type of most commonly reported adverse drug reactions in each arm or must the incidence also be comparable?

    Broad comparative claims relating to side effect profile are only considered when they appear explicitly in the Product Monograph. When based on a study, a safety comparison would be subject to all PAAB code requirements (including limitation to specific adverse events defined a priori with corresponding statistical analysis).

  165. The same pharma ad runs in the medical journal and the abstact meeting supplement, which are polybagged together. Can the PI run in just one or does the PI have to run in both the journal and the supplement? Or can there be only one PI -to be an outsert in the polybag?

    As they are polybagged, it is sufficient for the PI to appear in the regular publication provided the attached ads refer the reader to it for the PI. This meets the PAAB code section 6.1.2 requirement that the PI be an integral part of the journal advertisement.

  166. Bonjour, Article 3.5.1 du Code indique Le corps du texte doit faire référence aux résultats négatifs d'une façon nettement visible. Qu'entend-on par résultats négatifs? Comment interpréter ou comprendre cela alors que pour notre catégorie de médicament, aucun effet négatif n'apparait à la licence de mise en marché (DIN-HM). Je vous remercie par avance pour votre réponse?

    Vous ne pouvez pas choisir de faire paraître dans vos annonces publicitaires uniquement les meilleurs résultats que vous avez obtenus à vos études cliniques. De plus, le CCPP vérifie dans la licence, l'étiquette ou la monographie du produit s'il y a des problèmes d'innocuité ou des restrictions quant aux indications ou à la posologie. Le cas échéant, ceux-ci doivent apparaître dans l'annonce publicitaire au titre d'énoncé de juste équilibre. Par exemple, « ne pas administrer à des enfants de moins de 12 ans », ou « diminuer la dose chez les personnes âgées ». Vous avez de la chance si vous n'avez pas beaucoup d'énoncés négatifs sur votre produit.

  167. Hello, i am looking fro an official definition of on-label as it relates to conversations that a pharma rep can have with a HCP. Although all material need to be PAAB-approved, verbal exchange in the office can touch on latest data publicly available, such as posters, conference reports, etc. If referring to approved dosage, patient population and condition, can the reps discuss this with physicians in an effort to have robust clinical and scientific discussions... best regards

    "On-label" is equivalent to "consistent with the Terms of Marketing Authorization (label, product monograph, product license) that has been approved by Health Canada." See PAAB Code s3.1. Verbal discussions by sales reps are covered by the Food & Drugs Act and Regulations. Therefore, a representative can talk about new studies that are not part of the product monograph if the content is consistent with the indications, dosing, and degree of efficacy and safety stated in the Product Monograph. Rule of thumb - if the PAAB would not approve the information in a print piece, the rep should not be promoting that information verbally. Also see Rx&D Code of Ethical Practices s5.1.1.5.

  168. We would like to reference other clinical studies from independent researchers relating to our product. Purpose is to highlight other research results & findings on different groups of patients. Research has been submitted with the PLA to support other claims used on the packaging but this research claims additional benefits. Am I able to use this research to state the results from these studies without it being in conflict of the claims made on the packaging/PLA? Please advise.

    PAAB Code Section 3.2 allows for use of published, peer-reviewed Randomized Controlled Trials, that are not in the Product Monograph, to support claims in advertising if the claims are consistent with those in the Product Monograph or labeling.

  169. Does a letter announcing provincial listing for a drug need to be PAAB'd? The letter will be a direct mailing from the pharmaceutical company to HCPs in the province announcing the listing, reimbursement criteria and indication of the product.

    A letter announcing provincial listing for a drug is required to undergo preclearance if includes reimbursement criteria/indication. Note that the preclearance exemption under PAAB code section 6.6(d).ii. only applies to a formulary listing announcement which is not linked to a therapeutic claim in any way (e.g. an ad containing only the product name and "Now on formulary").

  170. I am a Strategic Account Manager for a Pharma Company in Toronto. My clients are Director Level and higher in Hospitals and we would like to produce a slide kit for meetings with Hospital Executives which provides information on our company (history, mission statement, values), examples of unrestricted educational grants that have been requested by organizations, information on our supply chain process and stability, PAAB approved educational & safety booklets for HCP and patients and a list of our hospital products which are approved for sale in Canada. The presentation will not include an product claims or promotional statements. Based on the PAAB Code, please confirm if this presentation is exempted from PAAB Review as it does not contain any communications in which claims, quotations and references are made for healthcare products.

    This piece is not exempt. Institutional messages which include product mention should be reviewed under PAAB code section 7.4. Institutional messages which do not include product messages are exempt from preclearance as per PAAB code section 6.6.

  171. How do you review electronic detail aids created for tablets/iPads? Which technical features can be included in electronic details that would allow for easier detailing over a tablet/iPad? - Search keywords - highlighting sections - animations - organizing content into tabs (dosing, safety etc)

    A copydeck can be submitted for review of copy. Layout requirements can be met with screenshots (can be submitted when copy is in order). See below for requirements relating to animations.

    Tips for animations/video/interactive games
    Storyboards may be submitted for initial layout reviews (i.e. to describe animation of figures/images). However, a video will be required for review prior to acceptance.
    PAAB should be informed of all animation attributes/functionality. For example:

    • Will the animation play automatically when the page is open or is user interaction required to initiate it?
    • Can the user play/pause/restart the animation? If so, how? For iPads, a finger swipe left to right is sometimes used to move the animation forward while a swipe from right to left is often used to rewind it.

    Tips for roll-overs (aka mouse-overs) and pop-ups in e-tools

    • In representative directed tools: Study parameters may be presented as pop-ups which appear once the drug representative clicks on the claim or performs a mouse-over.
    • In self-directed tools: For self-directed electronic tools, the piece should somehow instruct the user how to obtain the study parameters (e.g. instructions at the beginning of the piece).

    Disclaimers or balance copy should not be relegated to pop-ups or roll-overs unless use of the corresponding claims is limited to the same roll-over or pop-ups. Also, Claims and supporting data should appear together (not one without the other).

    Zoom-in and Scroll
    Although users can zoom-in and scroll, the default fair balance emphasis is still required to be similar to the claim copy. For example, fair balance prominence is not acceptable when users need to zoom-in to read the fair balance if most of the claim copy is legible without the need to zoom.

    Links
    Electronic media simplify the creation of links. Links can be created within the piece. Links can also be created to other pieces/tools/documents (e.g. full study reprints). PAAB should be made aware of all links during initial review.

    Tabs
    When tabs are used, it should be clear what information they contain and how the tabs (and the contents within them) are organized.

    Scanning a PAAB approved APS
    We are frequently asked whether scanning a print APS onto an electronic platform requires resubmission to the PAAB. Resubmission is not required provided the same content/layout/flow is maintained as the approved print APS (i.e. the piece on the electronic platform is comprised simply of all scanned pages in same order as the print APS). Note that the originally submitted piece is required to be renewed on a yearly basis for the duration of its use (whether the use relates to the print or electronic format, or both). Content on the pages may not be repositioned (e.g. to optimize for landscape mode) without resubmission for review. Also, no new functionality can be added without PAAB review (other than zoom-in and scroll).

  172. Dear PAAB, We have been asked to prepare a slide presentation for our sales reps to use for group presentations to customers. These events vary in length from 20 to 60 minutes. It is not possible to create a separate slide presentation for each event. We propose a 'core' deck with the essential safety and efficacy information, and an 'enhanced' or 'expanded' deck with additional published data. Both would be PAAB-approved. In cases where there was insufficient time to present the larger presentation, the core slides would be presented and would be supplemented with a number of slides from the PAAB-approved 'expanded' presentation. Is it possible to use 2 approved slide decks in this manner? If so, how should they be submitted to PAAB for approval. Thanks for your interest.

    Preclearance is most effective as a regulatory mechanism when promotional tools are used in the precise way in which they were reviewed. In your provided example, the expanded presentation could indeed be reviewed as a potential add-on to the core presentation. However, the review (and approval) would presume that the complete expanded deck would be presented.

    Additionally, the slides in the expanded deck should be presented in the same order that they were reviewed. If further personalization is required to account for variability in time constraints, you may wish to separate the expanded slide set into several smaller packs of slides. Each pack would be reviewed as separate submission files but with the understanding that they will always be presented after the core slide set (such that standard fair balance elements need not be duplicated in each slide set). Because each expanded pack will be reviewed as distinct files, PAAB can ensure that any element used in the expanded segments will be accompanied by the required copy-specific balance, quantification and/or qualification. Note that any presented expansion pack must be presented from beginning to end with all slides used in the same order in which they were approved. The client will be free to include as many or as few of the expansion packs as time permits. Each expansion pack should be separate and distinct sections of the presented slide set. For example, this could be attained by employing a cover slide identifying the key topic(s) for each expansion slide (e.g. "Dosing").

  173. When submitting a file for review by the provincial governments for the purposes of securing or improving reimbursement status, do any of the materials need to be submitted to PAAB? Thank you for your help.

    The Health Canada Policy document "The Distinction Between Advertising and Other Activities" has a section on formulary kits. The kits are materials prepared for review by pharmaceutics and therapeutics formulary committees, on which a decision to include a drug product in a formulary may be based. Such information may not be advertising provided the information is limited to that which would normally be required to support such an application. If this is the case, there is no need for PAAB review. Where such an information package is disseminated, in whole or part, to a wider audience simultaneously, or at a later date, it may be advertising to promote the sale of the drug concerned. In these cases, the material should be submitted for PAAB review. Note that the PAAB has received complaints from provinces about unrequested promotion that should have been PAABed.

  174. I understand a branded paid search ad cannot use keywords that go beyond name-price-quantity. However, if a person searches for the brand name keyword in conjunction with the disease-state keyword, does this not identify them as a patient or someone who is already knowledgeable about the product? Could a branded ad be presented if the searcher has already made the brand-disease connection themselves?

    No. There are only 3 audiences from a drug advertising regulatory perspective. Consumers, patients, and HCPs. Conducting an internet search containing the drug and the corresponding disease does not make you a patient or an HCP. The composite of the purchased keywords, the metadescriptor, the landing page and its URL must not exceed name, price, and quantity for a prescription product. These elements may not create a link between name and therapeutic use for a product indicated for the treatment of a schedule A disease. On a separate note, keep in mind that product ads cannot be directed to patients anyways (i.e. for Rx products, patient information must be non-promotional).

  175. If a company wants to make physicians aware of an optional training program by sending a letter, will the letter be reviewed by PAAB or it is content-dependamt? Any guidance on the training materials provided to physicians at the training?

    Can PAAB review it? Yes. Does the code require that the content be reviewed? The answer is partially dependent on content (both the content on the invite and the content in the "training program"). BUT, a more comprehensive way to approach this is to ask yourself "is this advertising?" I refer you to the Health Canada policy document "The Distinction Between Advertising and Other Activities". It Invites us to determine whether the advertising regulations apply by assessing the answers to the following 7 questions:

    • What is the context in which the message is disseminated?
    • Who are the primary and secondary audiences?
    • Who delivers the message (the provider)?
    • Who sponsors the message and how?
    • What influence does a drug manufacturer have on the message content?
    • What is the content of the message?
    • With what frequency is the message delivered?

    Content is only one of the 7 factors. No one factor in itself will determine whether or not a particular message is advertising. If it is advertising and it does not meet the exemption criteria in PAAB code section 6.6, the letter should be reviewed by the PAAB. We can help you determine whether it is advertising if you submit an opinion through the eFile system (i.e. we'd need the answers to the above 7 questions).

  176. If a DIN-gated patient website has been approved, can Sales Representatives showcase the website to physicians?

    A sales representative can showcase the website to physicians. The activity should be tailored to informing the physician that the site exists (such that he/she knows to direct patients who've been prescribed that particular medication to the site). The sales representative should not be detailing off of the patient site under the pretense that this is HCP targeted content.

  177. Hi, If a company has a DIN for a human pharmaceutical, but does not have a vet DIN, are they allowed to advertise it, provided they are transparent that it is not vet DIN approved? Thanks!

    Veterinary advertising does not fall under the scope of PAAB.

  178. Is it necessary, whenever a letter pertaining to your product is sent to a government official (either elected or part of the public service, at all levels of government) to include a copy of the Product Monograph if you refer in passing to an issue you may be having as it relates to your drug. For example, if we were bringing to the attention of Minister XYZ about Product A not being approved fast enough by internal bodies to meet the demands of physicians/patients, would we then have to include the PM simply because we mentioned the name of the product? Also, is it necessary, in private correspondence to government officials that is exempt from PAAB pre-clearance and non-promotional, to include both the generic name of said product, the dosing information, etc?

    The advertising regulations apply to advertising. A letter sent to a government official is a one-on-one correspondance (i.e. the advertising regulations would not apply). The letter should be non-promotional. It is therefore advisable that this activity not to be overseen by the marketing department. Although the activity we've described is likely not subject to the provisions of advertising, it would appear to be a good idea to include the PM or PI as a comprehensive resource for product information.

  179. I understand that a Canadian consensus guideline is an acceptable, authoritative source. Correct? If the consensus is published in a peer-reviewed journal, but it is not explicitly called a "guideline" in the title, is this acceptable? (E.g., "Canadian consensus on..." or "Canadian clinical guidance...")

    Whether the title contains the word "guideline" is typically not in and of itself a pivotal factor in PAAB approval. It is more important that the source be reliable and authoritative. Statements taken from Canadian authoritative guidelines (e.g. place in therapy) can be considered in drug advertising provided they are consistent with the Terms of Market Authorization (s3.1) and based on good evidence. While some guidelines are published, they may not be endorsed or recognized by an authoritative medical body and therefore may not be reflective of current medical practice (s3.2). Note that a nationally recognized consensus would be preferred over a regional consensus.

    Note that content from Canadian authoritative guidelines is not automatically accepted in APS. All PAAB codes must be considered.

  180. Hi there, If a company wants to write a private letter to MPs, Senators, government officials (elected or appointed) with regards to their product, issues a company is facing with regards to approvals/existing regulations/legislation etc, does that letter require PAAB approval? To what extent are pharmaceutical companies required to submit letters to government officials to PAAB for review/approval?

    A letter to an MP, Senator, or government official would be exempt from PAAB preclearance. The letter should be issue oritented and not promotion oriented. We've been made aware of complaints relating to formulary bodies receiving drug advertising.

  181. Dear PAAB: We have a HCP-directed APS for a congress announcing "Company A name" and "Product B name" are "now here" in Canada. An offer to "visit at Conference Booth XXXX" is included. There are no further product / therapeutic claims.
    1. Is this exempt from PAAB preclearance review, as per the "now available" exemption in S6.6?; and
    2. If so, may we include product branding elements / visuals and maintain exemption?

    Thanks!

    The specific examples listed in PAAB code section s6.6 would be considered exempt. When using alternate copy and/or adding visuals, I suggest submitting a written opinion request for exemption (i.e. we'd need to view the specific piece for assessment).

  182. Are printed PI pages still required for journal print ads, or can a web site be given within the ad directing the reader to the PI? Assume that claims are being made within the ad. Thanks

    Printed PI pages are still required. Please refer to PAAB code sections 6.1, 7.1, and 7.3. The current PAAB code can be accessed at the following URL:
    http://www.paab.ca/local/files/PAAB%20Code%20Eng%20April%2017%202009.pdf

    Stakeholder consultation regarding draft PI requirements proposed by an expert committee is currently ongoing. Health Canada will be providing input. See the following URL for more information:
    http://www.paab.ca/en/paab_code/paab_code_review/

    A PAAB code change would require at least two-thirds of the PAAB Board of Directors to vote in favour of the change. Please call Patrick Massad at the PAAB if you have any questions.

  183. What type of guidance is there regarding the inclusion of product pipelines in Canadian corporate websites?

    Promotion of a drug prior to market authorization would contravene Section C.08.002 of the Food and Drugs Regulations). Note that one also needs to consider the consumer regulations as corporate sites are open to the general public. Given these two considerations, it is critical to ensure that the activity is not promotional. Please refer to the Health Canada document "The Distinction Between Advertising and Other Activities".

    The following guidance is particularly relevant to this specific question:

    • the content should be directed to shareholders or potential shareholders. On a website, this could be achieved by including the content in the "Investor Information/Relations" tab.
    • the content should be limited to the name of the drug and its proposed therapeutic use (e.g. chemical x for condition Y is in phase II studies).
    • no statement can be made regarding the degree of safety or efficacy expected and no comparisons should be drawn with other treatments.
    • the document should not be emphasized and it should be devoid of promotional statements
    • the content should include a prominent disclaimer that the products have not been approved.
  184. Dear PAAB, I'm reviewing a Dear healthcare professional letter to anounce a new packaging of a product. the letter is one page but our standard balancing information in arial 10 font is one page and a half, which is longer than the actual anouncement. I was wondering if it is acceptable to keep the indications contraindications and serious warning and precautions only du to the size of the anoucement. thank you very much for your assistance!

    The overall presentation of information in any ad must not convey a deceptive impression of the risk or benefits of a drug. The cumulative balancing content required in an ad to avoid such deceptive impression is determined by the interplay between multiple distinct variables. Specifically:

    • product-related variables: such as the product's Federal schedule and the risk profile conveyed in the Terms of Market Authorization, AND
    • variables related to the ad’s marketing claims of benefit: such as their general type, and the number/comprehensiveness of claims requiring specific balance that would otherwise not be required in the ad

    Given these variables, we would need to assess the ad and the product’s Terms of Marketing Authorization in order to answer your question. Please call me at 905-509-2275.

  185. Can a cover tip ad cover the complete front cover of a medical journal? If not, what is the max. percentage?

    The PAAB does not rule on the maximum size of cover tip ads. Contact the publications as they may impose such restrictions.

  186. Do different guidelines exist for promotion of OTC brands to health care professionals with respect to the following:
    1. comparison of different products based on the approved labelling for parameters such as indications, and the non-clinical claims such as taste,color, odor, dissolution. Section 5.10.2. of the code does not distinguish between Rx and OTC brands.
    2. use of ASC approved consumer taglines for the brand in APS that will be used with healthcare professionals.

    No. Audience is an important determinant of advertising regulations. All elements of an ad directed to healthcare professionals are reviewed by PAAB within the provisions of the PAAB Code of Advertising Acceptance (e.g. taglines, non-clinical comparisons, and so on). OTC advertising directed to the general public is reviewed either by ASC or MIJO within the provisions of the Health Canada guidance document "Consumer Advertising Guidelines For Marketed Health Products".

  187. Why is it that medical devices do not undergo the same scrutiny (PAAB approval) as prescription medications with regards to promotional tools?

    The scope of the PAAB code currently excludes healthcare products approved by Health Canada as medical devices. The MEDEC Code of Conduct applies to such advertising. You can send complaints on medical device advertising to Health Canada. Use the following contact information:

      Drug Compliance Verification and Investigation Unit
      Tel: (613) 952-9906
      Fax: (613) 954-0941
      E-Mail: DCVIU_UVCEM@hc-sc.gc.ca
  188. I am hoping that you can help provide us some guidance with respect to the use of "Now on Formulary" stickers. It is our understanding that such stickers are exempt from PAAB review as long as they are not linked to a therapeutic message in any way as per Section 6.6 d(ii) of the PAAB code. In the past when we have submitted such stickers to the PAAB, we have been asked to provide examples of where a sticker will be placed on previously approved APS. This occasionally becomes a problem when trying to assess viable placement options. For us, the guiding principles have been the following:

    1. Based on proximity, the sticker cannot be placed so as to be linked to a message(s) on the APS.
    2. The sticker cannot obstruct a message / copy or a visual in any way.

    Can you provide us with any additional criteria that provides us with further guidance on:

    1. where a sticker can be placed and/or
    2. where a sticker cannot be placed to help us in discussions with our clients?

    Thanks for your help.

    PAAB should be made aware of all post-approval changes. Please note that by adding stickers to already approved pieces, you are changing the piece and we should be kept informed of such changes (not just examples of those changes).

    With respect to your specific scenario, addition of the banner “now on province x formulary” to an existing piece may be considered an “FYI” post-approval change which would not require PAAB preclearance. The following conditions are required for this type of post-approval change to be considered for assessment as an “FYI”:

    • The APS to which the content is added is still within the one year PAAB pre-clearance period.
    • The content added to this existing piece does not include additional text beyond “now on province x formulary” (or equivalent).
    • The added banner is separate and distinct from the other APS messaging.
    • The added sticker does not obstruct content on the piece in any way.
  189. I know that an on-label reprint distributed in a promotional context (ie by a sales representative) needs to conform with the PAAB Code, but does it need to undergo PAAB review?

    Dissemination of full, unedited articles from medical or scientific journals whose peer-review was steered by the publisher's editorial board are exempt from PAAB preclearance (PAAB code s6.6).

    As you've already identified in your question, the advertising regulations would still apply due to the promotional distribution context (i.e. drug reps). Don't hesitate to request a written opinion from PAAB to obtain an independent assessment of whether distribution of the reprint in this manner is aligned with the advertising regulations. Visit www.paab.ca for the fee schedule.

    Note that materials written or edited by an employee or agent of the pharmaceutical manufacture should be precleared by PAAB.

  190. Could an online-only textbook (such as CCO InPractice) meet the requirements to be used as a reference for the PAAB? It is accredited for education by the AMA and is third-party to the drug company.

    Generally, an independently published, authoritative textbook is an acceptable source for disease information whether it is in print format, electronic format, or both. Authoritative means recognized by a medical academic institution or bona fide medical organization that provides education. For assessment of specific sources, feel free to submit a written opinion.

  191. I have a Patient Instructional Video for an Injectable Therapy. It has video footage that was developed originally in the United States and shows a Sharps Container that is Red in colour. In Canada, sharps containers are yellow. We would prefer to use the same footage for Canada. Is it acceptable to use a disclaimer in the video that states "In Canada, Sharps Containers are Yellow in Colour"?

    Yes. But the disclaimer should be prominent to avoid confusion. Note that the video requires PAAB review under section 6.4 of the PAAB code. Please call the PAAB office if you have any questions.

  192. Does an ad for a medical imaging contrast agent need to be PAAB approved?

    Yes. The Code applies to all healthcare product advertising directed to healthcare professionals. This includes products for in vivo use in the diagnosis of disease/disorder or abnormal physical state. PAAB code section 1 describes the scope, section 11.3 defines healthcare products within the context of that scope. Also see PAAB code section 6.6 for exemptions.

  193. We have a new product under review by Health Canada. A part of the approval is the preparation of the Risk Management Plan, which includes a slide deck for HCPs outlining the safety issues with the medication. Should this slide deck be PAAB approved? if yes, how do we go about this, given that PM is not yet approved?

    If Health Canada has reviewed AND ACCEPTED the slides, there is no need for a PAAB review. Otherwise, the content should be reviewed by PAAB prior to distribution to healthcare professionals. Our pre-NOC submission policy can be found on the PAAB website. Here is a direct link: http://www.paab.ca/en/paab_code/supplementary_paab/prenoc_advertising_submissions/. If you have any questions, please call the PAAB office.

  194. Is there any guidance about websites designed for the provision of medical information to registered heath care profesionals in Canada. These sites are non-promotional and allow HCPs to access information after having completed a specific search on their own. The obvious advantage is to allow 24/7 access to information useful to help in patient care.

    The Food and Drugs Act, the PAAB Code and The Rx&D Code of Ethical Practices have requirements regarding provision of information when it is "advertising". Advertising is regulated, non-advertising information is not regulated. The Health Canada document "The Distinction Between Advertising and Other Activities " states the requirements to make information become non-advertising http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/actv_promo_vs_info-eng.php in any media. The "PAAB Code of Advertising Acceptance" section 6.5 covers internet activities sponsored by pharmaceutical companies.

    See also the Health Canada policy "Health products advertised on physician websites" at http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/web-qa-qr-eng.php Therefore, if the site is truly non-promotional, it is not regulated.

    The following best practices would increase your chances of keeping the site outside of the “advertising” (i.e. regulated) realm:

    • The website shall be set up such that the process for requesting information mirrors the process a healthcare professional would follow if they were to call the Medical Information Department directly.
    • The platform is kept separate and distinct from any advertising.
    • This service will be defined by the following three characteristics: restricted access, specific key-word based searches, and documentation.

    Restricted access: For example, only healthcare professionals can access the website. They do so by entering a user name and password provided after completing registration. Registration includes a mechanism which ensure that the registrant is indeed a healthcare professional.

    Specific key word searches: For example, medical information responses provided in the form of medical information letters (MILs) addressing specific questions. The MILs would be the same as those used to respond to verbal requests. The MIL responses would be accessible by entering specific key words into a search engine. Those key words are exclusive to each letter such that a key word entered could only result in the retrieval of one letter (i.e. it will not be possible to perform general searches based on text words).

    Documentation: For example, the system would be configured such that it is possible to identify users to whom specific MIL responses have been provided. The user, the date, the keyword search and the information provided would be recorded by the system.

  195. Dear PAAB. What jurisdiction does PAAB have over reprints and in particular reprints that may not be acceptable for promotional material but are consistent with and within indication. An example would be a review article?

    Journal reprints per se are not subject to PAAB review. If they are consistent with the Terms of Marketing Authorization they can be distributed complete and unmarked (no emphasis). That can include review articles. Please remember that when journal reprints are distributed in a promotional manner i.e. detailed by reps or are used as references to support advertising claims, they must meet all the requirements of the PAAB code, especially s2,3,4 and 5. They can be distributed by the medical department upon request for specific information and not be considered advertising. See also "The Distinction Between Advertising and Other Activities" and the Rx&D "Code of Ethical Practices" which have requirements specific to journal reprints. The Distinction document says this about textbooks and reprint articles:

    "Dissemination of full, unedited reference texts (textbooks, chapters of textbooks), government publications or reprints of published, peer-reviewed articles from medical or scientific journals, that are identified as being provided courtesy of a pharmaceutical manufacturer, may be a nonpromotional activity provided that: no link between the text and promotion of a drug is established by the manufacturer.
    Such material may be considered to be advertising where the aforementioned condition is not met or where other factors indicate that the primary purpose is to promote the sale of a drug, for example: the material is accompanied by any form of additional information (e.g., printed, word of mouth) designed by or on behalf of the manufacturer for the purpose of promoting a drug (e.g., detail aid), the material was written or edited by an employee or agent of the pharmaceutical manufacturer, a summary or interpretation of the text prepared by the pharmaceutical manufacturer or his agent accompanies the material, reference is made to the availability of an unauthorized drug through the Special Access Programme."

  196. Dear PAAB: Does inclusion of a product Name, and its associated DIN, adhere to name/price/quantity guidelines in c.01.044? Does package size (i.e. weekly, monthly and number of tablets) meet the regulations for quantity? Many thanks.

    Including the DIN in a reminder ad for a prescription drug directed to consumers does not adhere to the letter and spirit of Section C.01.044 of the Food and Drug Regulations. As you may be aware, reminder ads are acceptable provided that there is no allusion or link to the therapeutic indication of the advertised product. However, as it is often the case with reminder ad campaigns, market authorization holders set up a branded prescription drug Web site where patients who have been prescribed the prescription drug can enter the DIN in order to get access to the full product information. This practice has been deemed acceptable by Health Canada as it acts as a mechanism to restrict access to patients, and not the entire general public. Therefore, in such a scenario, providing the DIN in a reminder ad would likely constitute a direct-to-consumer advertising in contravention of Section C.01.044. With respect to your question about package size, we would suggest that you restrict the quantity claim such that it relates to the number of units provided for the price, as this will provide accurate information as to the unit price. If your question is more related to product package representations, we invite you to consult the Health Canada policy entitled "Product Package Representations in Branded Prescription Drug Reminder Ads Directed to Consumers" available at: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/notice-avis_reminder-rappel-eng.php.

  197. Do personal (i.e. one to one, not mass generated) emails to HCPs announcing a product is "now available" need PAAB pre-clearance review? May such emails that mention a product also include brief mention of the general indication, disease state or therapeutic use? Thanks!

    No, PAAB preclearance is not required for any piece containing only the drug name and the claim "now available" s6.6. This is true whether the same piece is sent to one HCP or many HCPs. However, adding anything else (e.g. the indication, disease state or therapeutic use) renders it PAABable.

    Additional related notes:

    • Situations where the piece is provided to an individual in response to a request for information that has not been solicited in any way is exempt from pre-clearance. It appears unlikely that an HCP requests a piece containing the message “Now available” and the product indication. s6.6
    • Note that simply personalizing the greeting line (i.e. Dear Doctor John Doe) does not render the piece exempt for PAAB preclearance when the intent is to send the core message to multiple HCPs.
  198. Can we use a 2D / 3D scan tag, QR Code to carry the prescribing information that may otherwise be physically attached to the collateral?

    No. PAAB code section 7.3 states that Prescribing Information (when required) must be attached to the presentation or be distributed with it. A scan tag or QR code would not meet this requirement. Health Canada confirmed recently that this also remains their current position. An APS which fails to meet the prescribing information requirement may be contravening section 9.1 of the Food and Drugs Act. The PAAB is currently working on proposing alternative PI presentations, and will approach Health Canada with a report/request after appropriate analysis and stakeholder consultation.

  199. If a physician who was not able to attend a congress/confrence(e.g. ASH, ASCO, ADA) requests through medical information slides on company studies presented at the congress are we allowed to provide them?

    The Health Canada policy document "The Distinction Between Advertising and Other Activities" does not consider responses to specific questions from a medical info department to be advertising. The request should be SPECIFIC and DOCUMENTED. Such a response would be exempt from PAAB preclearance review in accordance with Code s6.6(b). We remind you that, while a company may promote the fact that it has a medical information service, it should not promote individual studies that are not consistent with the product's Terms of Market Authorization (TMA). If drugs are mentioned in an institutional message, even within study titles, PAAB preclearance review is required per Code s6.6(e).

  200. When introucing a new drug can we put the Health Canada classification, i.e. Angiotensin II receptor blocker or angiotensin receptor blocker of the drug on the same page as clinical information.

    It is possible for the Health Canada pharmacological classification and claims within the limitations of the Terms of Market Authorization to appear on a single page. However, to avoid according clinical significance to the pharmacological classification, the claims will need to be presented such that they are separate and distinct messages. Call the PAAB office if you have any questions.

  201. Can PAAB provide some guidance on the use of physician quotes in promotional material? Can video clips of physician quotes be used at conferences?

    Physician quotes can be used in advertising. Quotations should be verbatim (and in the same context as the source) with any deletions identified by a series of dots. The sponsor is responsible for securing permission to quote the physician where this is necessary. If it is a fictitious doctor, a disclaimer should clearly disclose this. Aside from that, physician quotes in advertising are held to the same standards as the advertising copy which accompanies them.

    Physician opinions or testimonials are non-evidenced based statements (s3.1.3). Therefore, any statements or claims made in the quotation must be supported by, and referenced to, rigorous evidence. For example, all statements and claims should be within the limitations of the Terms of Market Authorization (PAAB s3.1), statements about place in therapy should also reflect the Canadian consensus guidelines (PAAB s3.2), some statements and claims may require insertion of qualifiers or quantifiers within the APS, and so on.

    Some companies prefer to give the healthcare professional (HCP) a pre-approved script (or at least speaking points) in order to obtain a larger number of usable quotes from him/her. Don't assume that physicians know advertising regulations. Remember too, that PAAB review is a regulatory review, based on the Terms of Market Authorization and the entire PAAB code.

    If your objectives call for more free and open dialogue with the HCP, it is a good idea to submit the questions to PAAB for a written opinion ahead of time. Often, asking the question the right way can improve the odds of getting an answer which can be accepted in advertising. It is also a good idea to inform the HCP about the pertinent advertising regulations. The fact that a doctor said it does not exempt it from the regulations. Ultimately, the sponsor is responsible for all advertising content including HCP quotes.

  202. For our Vaccines web sites which are branded, we would like to include a link to our unbranded Digital Video News Release (DVNR) which will be housed on YouTube. We are also considering storing a PDF version of our unbranded matte stories on the website. Is there any concern with placing unbranded materials on a branded web site? Does it matter if it is a Vaccine or Rx product?

    With respect to your specific questions, the main concern with placing unbranded materials on a branded web site is that you would be linking the unbranded content with the brand (i.e. this could essentially "brand" the "unbranded" content). There are multiple implications to this (and this is where the federal schedule of the product comes into play as per your second question):

    Advertising for all products (whether Rx or vaccine) must be in accordance with the Terms of Marketing Authorization granted by Health Canada . If the disease content on the video extends beyond the indication of the product featured on the site, the sponsor may be violating section 9(1) of the Food and Drugs Act.

    Specifically for websites promoting an Rx product or a product indicated for the treatment of a schedule A disease, there is an additional concern. The consumer accessible portions of such websites should not link the product to its therapeutic use. An unbranded disease video may do this.

    The PAAB can help you get it right through the preclearance review program and/or opinion advisory for DTC advertising. You should familarize yourself with the "Press Releases" section of the Health Canada document "The Distinction Between advertising and Other Activities" because your You Tube DVNR site may not meet all of the requirements of an exemption for advertising.

  203. Can you help me understand the difference between the "requirements of the code" and the "explanatory notes." More specifically if we are not contradicting the requirement of 3.1 and are consistent with the TMA or paraphrasing the TMA how can we then be contradicting an explanatory note?

    The left side of the code lists the principles and standards. The right side gives examples or interpretation as a guidance that does not fit all scenarios. Paraphrasing is subject to interpretation as well. You must meet the requirement in the left side.

  204. If a pharmaceutical company was to sponsor a Canadian Association's medical educational piece, would this require PAAB approval?

    A pharmaceutical company can sponsor a Canadian association's medical educational piece. Determining whether the piece is exempt from PAAB preclearance involves considerations beyond simply the existence of sponsorship. Let’s go over some common scenarios and discuss the answer for each.

    Scenario #1: An existing piece which had already been independently controlled and prepared by the Canadian association with industry involvement limited to purchase and sponsorship of distribution. Exempt from PAAB pre-clearance.

    Note that content which is exempt from PAAB preclearance is not necessarily exempt from the advertising provisions of the Food and Drugs Act/Regulations and the principles of the PAAB code. For example, distribution in a promotional context (e.g. by drug representative) may render the message promotional.

    Scenario #2: A pharmaceutical company has provided an unrestricted grant to a Canadian association for the creation of a medical education piece. Exempt from PAAB pre-clearance.

    In this scenario, influence from the pharmaceutical company is limited to selection of the broad therapeutic area (i.e. broad area of interest rather than specific topic). The pharmaceutical company has no awareness of the content until the piece is complete at which time the company may simply determine whether it will use the piece. Again, note that content which is exempt from PAAB preclearance is not necessarily exempt from the advertising provisions of the Food and Drugs Act/Regulations and the principles of the PAAB code. For example, distribution in a promotional context (e.g. by drug representative) may render the message promotional.

    Scenario #3: A pharmaceutical company exerts influence over the process or content generated by the Canadian association. Not exempt from pre-clearance if it is a healthcare professional directed piece discussing pharmacotherapy.

    The piece would require PAAB pre-clearance if the pharmaceutical company or its agent has influence over the content or process beyond selection of the broad therapeutic area (e.g. providing specific directions regarding area of focus, input on author selection, input on scope of research, or editing privileges). In such cases, the piece would be reviewed as a product branded APS if the content emphasizes or favours the sponsor's brand. If the content does not emphasize or favour the sponsor's brand, it would be reviewed as an editorial APS.

  205. Would a cover/folder carrying the product monograph in its entirety (no edits, verbatim PM) require PAAB review? The cover/folder would have branding colors/ design (no implied claims) and simply state: "Brand X Product Monograph".

    No.

  206. I intend to send out a PAAB-approved promotional piece to physicians in a direct mail campaign for an OTC product. I was also considering including a product coupon. The coupon will display the brand name, package shot and discount amount. There will be no claims. Should the coupon be submitted to PAAB, given that it will be distributed in the same envelope as a promotional piece?

    In this scenario, the coupon piece should be precleared if claims are visible on the package shot visual within the APS. Otherwise it is exempt from preclearance.

    Either way, please inform us of the linkage to the PAAB approved piece. We would need to assess the appropriateness of the linkage. For example, the coupon piece should not accompany an editorial (unbranded APS) as this would inherently brand that piece.

  207. Is there any issue in company representatives handing out invitations to online medical education programs that have received accreditation?

    This activity is not necessarily a PAAB issue. See the Rx&D code section 8 about representatives activities and distribution of materials. CME can contain off-label claims which a company cannot legally promote. So is the rep promoting those claims by directing a viewer to that CME? The PAAB code covers materials, and thus it depends on the content of what is being handed out.

    Two schools of thought prevail here. One is the rep acting as courier. The second is if representatives are paid to sell product, why are they involved in a nonpromotional CME activity? They are creating a selling opportunity through the use of a specific CME event, thereby linking a promotional activity to a nonpromotional activity. Reps could promote the company CME service and not individual programs.

    We believe the more ethical road that stands up to public scrutiny and possibly avoid regulatory jeapardy is the latter.

  208. Please advise as to whether there are any particular requirements related to a US manufacturer providing medical information letters to Canadian physicians' unsolicited requests for information for a drug not authorized for marketing in Canada. The letters would be intended only for medical information, not for advertising purposes.

    The physician should be directed to contact the medical department of the Canadian subsidiary (in cases where one exists). One of the main concerns is potential confusion regarding the status of Health Canada approval for a product or a use. For example, in cases where a product or use is approved in the US, the US manufacturer would send a US Brief Summary for that product in addition to the specific response. This could potentially confuse/mislead a Canadian physician into thinking that a product or use has been approved here in Canada.

    In cases where there is no Canadian subsidiary (i.e. this medical service will need to be provided through the US), ensure that a US Brief Summary is not provided. This may require training of the medical department staff as it is counterintuitive.

    Aside from this nuance, the regulations pertaining to US manufacturers responding to unsolicited requests from Canadian physicians are the same as those pertaining to Canadian manufacturers.

    As per the Health Canada policy document The Distinction Between Advertising and Other Activities: "Information provided to an individual about a drug treatment(s) by a pharmaceutical manufacturer in response to a request for information that has not been solicited in any way (by the manufacturer of the drug) is not considered to be advertising for the sale of a drug".

    The response should be limited to that which is required to answer the specific request. It is advisable for the medical department to document the details regarding the request (e.g. date, name of requester, nature of request, content provided, etc). Please call the PAAB if you have any further questions about this.

  209. My submission now has the status "Response Required". How do I see the details behind this status? When I click on my submission, I only see the original submission and documents and no indication of what revisions or additional documents are required.

    If your file status has been changed to "Revision Required" you should have received an email with the Reviewers comments attached. If you did not receive the email, please check you spam or speak to your IT department to ensure PAAB is on your white list. Please call the PAAB if you require further assistance regarding your electronic submission.

  210. What is PAAB?

    Incorporated in 1976, the Pharmaceutical Advertising Advisory Board (PAAB) is a not-for profit, self-financing organization funded entirely by the fees paid by advertisers for preclearance review (not for the acceptance). The highly trained PAAB staff runs the preclearance program to ensure that proposed advertising meets Code standards for the promotion of pharmaceutical products. The PAAB code can be found at the following URL: http://www.paab.ca/en/paab_code/code/

    The code was created (and is maintained on an ongoing basis) by the PAAB Board of Directors. The following organizations are members of the PAAB and have appointed official representatives to its Board:

    • Association of Faculties of Medicine of Canada
    • Association of Medical Advertising Agencies
    • Best Medicines Coalition
    • BIOTECanada
    • Canada’s Research-Based Pharmaceutical Companies (Rx&D)
    • Canadian Association of Medical Publishers
    • Canadian Generic Pharmaceutical Association
    • Canadian Medical Association
    • Canadian Pharmacists Association
    • Canada’s Association for the Fifty-Plus (CARP)
    • Consumers Council Of Canada
    • Fédération des médecins spécialistes du Québec
    • NDMAC

    The PAAB mission is to provide a preclearance review that fosters trustworthy healthcare communications within the regulatory framework.

    The PAAB’s primary role is to ensure that healthcare product communication for prescription, non-prescription, biological and natural health products is accurate, balanced and evidence-based, and reflects current and best practice. The PAAB also monitors trends in health product advertising and promotion and adjusts its code and practices as required to fulfill its mandate.

    The scope of the PAAB includes promotional healthcare product communication for prescription, non-prescription, biological and natural health products to health care professionals in all media. PAAB also provides advisory comments on direct-to-consumer materials for prescription drugs. PAAB’s Scope evolves with the regulatory framework.

    Please visit our website at www.paab.ca for more information and don’t hesitate to call us at (905) 509-2275 if you have any questions. Also find us on LinkedIn, join the PAAB group and participate in the discussion!

  211. If we were to have a backorder situation for one of our products and we wanted to inform pharmacies of this fact by way of a letter or fax to help prevent a backorder, would this letter/fax need to be PAAB approved?

    I was reviewing section 6.2 for clarification, and believe that it does not need submission to PAAB (I believe it's an institutional message), however I'm not entirely sure?

    Actually, you would want to refer to PAAB code section 6.6.d. The intent of section 6.6(d) is to allow for the expedient communication of non-comparative, commercial messages. These include changes in availability, price and formulary coverage.

    If the only message in the letter/fax is that the product is backordered, than the ad is exempt from PAAB review.

    Clients often elect to also include messaging regarding alternative therapeutic options for consideration during the back order. This would be an example of something which would disqualify the ad from being exempt.

    Please call the PAAB office if you have any questions. Also refer to Q&A # 155.

  212. If the product trademark has changed from T to R, can the Sponsor change a previously PAAB approved material to reflect this trademark change without re-submitting to PAAB?

    Yes. Review of this change would not be required. We ask that the updated APS be sent to review@paab.ca as an FYI. It is important that the PAAB has the current version of the APS on file. Please call Laurie or Sabrina if you have any questions regarding FYIs.

  213. Under what conditions / what is the criteria in which a pharmaceutical company is required to report an adverse event in the social media sphere?

    Please refer to the Health Canada policy document "Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products". The following excerpt applies specifically to events described on internet sites (including social media sites):

      MAHs [Market Authorization Holders] should regularly screen Web sites under their management or responsibility for potential AR [Adverse reaction] case reports. MAHs are not expected to screen external websites for AR information. However, if a MAH becomes aware of an AR on a website that it does not manage, the MAH should review the case and determine whether it should be reported.

      MAHs should consider utilising their websites to facilitate AR data collection, e.g., by providing AR forms for reporting or by providing appropriate contact details for direct communication. Cases from the Internet should be handled as unsolicited reports. For the determination of reportability, the same minimum criteria (i.e., identifiable reporter, identifiable patient, suspect product and AR) should be applied as for cases provided via other ways. If the minimum reporting criteria are met and the report is considered relevant by a qualified health care professional from the MAH, the case is considered "reportable" and must be forwarded to the MHPD in accordance with the Regulations

    The entire document can be found here.

  214. Could a competitor product monograph or clinical study be used by sales reps during a call to answer a request? The info would be 'on label' and it would be for an unsolicited request (used reactively).

    The proposed activity is not advisable. These types of unsolicited requests are best handled through the company's medical information department.

    Although original research articles having undergone publication and peer-review are exempt from PAAB preclearance when they are not modified/annotated in any way, the context in which they are used may still render them to be "advertising" (and thus subject to advertising regulations). For example, drug representative dissemination/presentation of such articles containing content pertaining to pharmacotherapy would create an advertising context. This is true even if the documents are used by the drug representative only upon unsolicited request. As such, the pharmaceutical company should ensure that neither the activity (i.e. discussion) nor the references contravene advertising regulations. For example:

    • Content distributed about the Market Authorization Holder’s product must be on label.
    • Content distributed about the competitor’s products must not be disparaging (e.g. a selective/unfair attack).
    • Content pertaining to comparisons must be based on well-designed head-to-head, adequately blinded, RCTs.

    Market authorization holders are generally not in the business of promoting their competitor’s products. It is therefore likely that the selected competitor literature would discuss the competitor’s safety issues or failed efficacy endpoints. Note that this would be considered an unfair attack (as it is a selective presentation of negative attributes of a competitor outside of the context of an acceptable side-by-side comparison versus sponsor’s product). The content/activity would therefore contravene the advertising regulations. Market authorization holders should promote their products on their own merits rather than by selectively presenting the shortcomings of competitors.

    We do not anticipate issues with simply distributing a competitor’s product monograph in its complete & unedited form through the drug representative (i.e. no highlighting/underlining/summarizing). Ensure that it is the most recent version. But detailing about a competitor’s shortcomings using their product monograph would contravene the advertising principles stated above regarding selective/unfair attacks. This is again true even if it is done in response to an unsolicited request.

    Please call the PAAB office if you have any questions.

  215. In the PAAB code 6.6(d), you note a few examples of what would qualify as PAAB exempt. Working within the parameters of drug name only not linked to therapeutic message, would saying that your brand has "no generic equivalent" be appropriate?

    A section 6.6(d) exemption from pre-clearance review needs to meet BOTH of the following requirements:

    • The ad contains only the drug name
    • The ad is not linked to a therapeutic message in any way (e.g. the ad does not appear in proximity to an article on a disease for which the product is indicated)

    The intent of section 6.6(d) is to allow for the expedient communication of non-comparative, commercial messages. These include changes in availability, price and formulary coverage. Please note that while these items may be exempt from PAAB review, they may still be defined as "advertising" according to the Food & Drugs Act and therefore should adhere to the principles of the PAAB Code.

    With respect to your specific question, the proposed claim, "no generic equivalent", neither meets the first criteria listed above nor does does it match the examples listed in the explanatory notes. In addition, it is inherently comparative in that it refers to competitors (or lack thereof). Therefore, the claim is not exempt from PAAB review. Please call the PAAB office if you have any questions.

  216. Can you confirm if competitor names can be used as keywords for a branded Paid Search campaign?

    This would not go beyond the name/price/quantity restrictions of the branded drug or competitor, and would be no different than placing a branded Ad next to a competitor Ad in a publication, for example.

    Competitor names cannot be used as keywords for a branded Paid Search campaign. Section 6.5.3 of the PAAB code states:

      Sponsors should not provide the text of a meta data descriptor that contains direct or implied product claims to a search engine. Such items should be sent to the PAAB for preclearance review. Keywords and other meta data tags that refer to competitor products are prohibited.

    Please call the PAAB office if you have any questions.

  217. Can a pharma company place a product ad adjacent an editorial article in a healthcare journal if the article relates only to discussions about the condition that said product is labelled (no specific drug treatment mentioned)

    I’ll assume from the question that the editorial piece contains only disease information with no mention of drug therapy (e.g. no product or class/category). I’ll also assume that, in this scenario, the pharmaceutical manufacturer intends for this adjacent positioning to occur. Note that the context would essentially link the disease article to the product promoted within the adjacent ad. With this understanding, the following scenarios come to mind:

    In a healthcare professional publication:
    This adjacent placement may be acceptable. The disease messaging would need to be consistent with the constraints imposed by that product’s Terms of Market Authorization (e.g. product monograph) for that specific disease/condition. For example, if the product is indicated only for mild to moderate hypertension, the ad should not be placed next to a disease article about severe hypertension or the complications associated with hypertension such as heart attacks and strokes. Additionally, the product ad should prominently disclose indication & risk information relevant to use of that product for the adjacent disease/condition. The PAAB would ensure these requirements are met during review of the branded piece (i.e. clients should inform PAAB of the intended context during the review and include the editorial article - or anything known about the article - within the submission).

    In a healthcare consumer publication:

    • If the product appears on schedule F (i.e. a prescription product):
      This adjacent placement is not acceptable. This linkage would contravene section C.01.044 of the Food and Drug Regulations for a prescription drug (as the combined entity would exceed name, price, and quantity). The PAAB offers an advisory pre-clearance service for DTCRx advertising. See the PAAB website for details (www.paab.ca).
    • If the disease article pertains to a schedule A disease AND:
      • the product is indicated for the treatment of that disease:
        This adjacent placement is not acceptable. As per section 3 of the Food and Drug Act, neither a prescription nor a non-prescription product can be promoted for the treatment of a schedule A disease. This linkage would therefore contravene the regulations for consumer advertising.
      • the product is indicated & promoted only for the prevention of that schedule A disease:
        This adjacent placement may be acceptable. As per section A.01.067 of the Food and Drug Regulations, the non-prescription product (e.g. vaccines) linkage may be permissible. Note that the disease article needs to be consistent with the constraints imposed by that product’s Terms of Market Authorization for that specific disease/condition. Additionally, the product ad should prominently disclose indication & risk information relevant to use of that product for the adjacent disease/condition. The PAAB offers an advisory pre-clearance service for DTC vaccine advertising. See the PAAB website for details (www.paab.ca).

    Please don’t hesitate to call the PAAB office if you have any questions regarding this matter.

  218. As per question no.150, can we make a Quality of Life (QoL) claim based on a published peer reviewed study (condition/use on label) when there is no QoL data in the PM?

    The QOL data is not necessarily required to appear within the product monograph. The PAAB can consider a QOL claim based on a statistically significant improvement (versus an active or inactive comparator)observed in a published and peer-reviewed study which is blinded, randomized, controlled and designed a priori to measure this endpoint. The wording of the QOL claim should precisely reflect the endpoint which was measured. Also note that the indication will be considered in our assessment (e.g. some indications are limited to specific outcomes). Please call if you have any questions.

  219. If a pharma company sponsors a direct to consumer information (DTCI) site for Disease Awareness, can it talk about therapies (if they are all discussed equally, both drug and non-drug therapies)?

    I believe this to be "Yes". Assuming that, can the site also link from the therapy descriptions to branded drug websites as long as it handles all treatments equally?

    The answer to the first question is "yes" provided all requirements in the consumer brochure section of the Health Canada policy document "The Distinction Between Advertising and Other Activities" are met.
    We advise against linking various product websites even if this is done in an equivalent manner for all products.
    Note that:

    • The landing pages on the gated product sites should not be linked to the therapeutic content in the consumer brochure and vice versa. The linkage can be problematic on multiple fronts. For example:
      • With respect to the product site landing page: this linkage would exceed the name/price/quantity restrictions of the Food & Drug Regulations section C.01.044 (as the consumer brochure will discuss the therapeutic area).
      • With respect to the consumer brochure itself: This would link it to reminder advertising (i.e. the landing page prior to the gate). This linkage would compromise the “non-advertising” status of the consumer brochure. According to the Health Canada linkage principle, when advertising is linked to non-advertising, the combined entity becomes advertising.
    • This could confuse consumers as they will keep clicking onto these links only to get to landing pages which don’t allow them to go any further than the barrier.
  220. In 3.1 you state claims must be consistent with,and within the limitations of, the Health Canada Terms of Market Authorization. I assume "consistent with" means similar to or paraphrasing what is in the PM. What "limitations" of the TMA are you referring to?

    "Within the limitations of the ...TMA" means not extending beyond any of the restrictions imposed by the TMA (for example, if the TMA limits efficacy to a specific population, the marketing messaging should not imply otherwise). If you would like to talk about other examples, please call me at the PAAB office.

  221. We want to download our PAAB approved detail aid on an electronic pad for our reps to use. If there are no changes to the detail aid, do we need to re-submit to the PAAB?

    Second part is if the PAAB approved detail aid on the electronic pad has some interactive features such as animation of some charts or graphs do we need to re-submit it to the PAAB. If yes, in what format would it be submitted?

    In answer to the first part of the question: Resubmission is not required when there are no changes to the copy/flow/layout and no new links or interactive elements are added.

    In answer to the second part of the question: The electronic detail aid will need to be resubmitted as the interactive additions to the piece require review. If possible, the entire electronic detail aid should be submitted via script or screens shots with any changes, additions, deletions hightlighted on each page/frame/slide. Once English copy is approved we will need to see the finished product on a DVD to see the interactive elements. This piece should be created in .mov, .wmv or .swf file format and can only be uploaded to the efile system if it is 20mb or less in size. If the size is greater, you can ship a DVD to the PAAB office or we can download it from an FTP site if you have one. If you have additional questions, please contact Laurie Johns at PAAB.

  222. Can you provide an opinion on the use of reprints with information containing both within indication information and information outside of indication. The example would be a review article that has both, yet the direction to the sales force would be to highlight and promote the medical issue and the information consistent with the product's use and indication.

    It is our understanding that "use" of reprints refers to their distribution as part of the promotional mix. As per PAAB code section 3.1, reprints containing off-label content about drug therapy should not be distributed in a promotional context (e.g. through drug representatives). PAAB regards "off label" as content that is not supported by nor consistent with the Canadian Terms of Market Authorization (TMA). We would need to look at the study content (e.g. study population, dosages used, evaluated outcomes) in order to determine whether these parameters are in-line with the TMA or "off-label". Ask for an official PAAB opinion if you are unsure whether the paper is aligned with the product monograph. Drug promotion is regulated under the Food and Drugs Act; however, it is important to note that not all forms of distribution of reprints are considered promotional. Please refer to the Health Canada policy document "The Distinction Between Advertising and Other Activities". The section "Reference texts, Peer-reviewed Journal Articles" outlines the requirements for the distribution not be considered promotional. Your question mentions an example involving a review article. Note that these secondary references are not generally considered to meet the PAAB Code's standards for evidence for product claims (PAAB s3.1.1). As such, the published & peer reviewed paper should not be distributed in a manner directing the health care professional's attention to claims within the reprint in any way (e.g. through highlighting, insertion of sticky tabs, adding copy/summary or word of mouth). Finally, if distributed by drug representatives (or in any promotional context as per your question) the paper should not be off-label.
    Please call me at the PAAB office if you have any additional questions on this matter.

  223. I would like to understand what the average time (weeks/days) the PAAB currently are working to with respect to the review and approval of promotional materials from pharmaceuitical companies

    The PAAB's mandate is to provide an initial response within 10 working days of receipt of all required materials (e.g. the advertisement & the references). In 2010, the PAAB has met this target for 99.5% of files. In fact, the median time to first response in 2010 was 7 working days. For revisions, the PAAB responds within 3 working days.

    Keep in mind that the time to approval is also determined by how long it takes for PAAB's clients to respond and how willing they are to address the issues raised by the reviewer. In 2010, it has taken an average of 11 working days for clients to provide their revisions to the PAAB versus 3 days for a PAAB response. In 2010, it took an average of 2.4 revisions to get an approval. Caveat: interpret these two client averages with caution as there is significant variability between different agencies/manufacturers. Call me if you would like to know averages specific to your company.

  224. A company has applied for unrestricted formulary status in a province, and expects this to be granted shortly, and wants to get the news out as quickly as possible after officially hearing.

    We understand that DM with a "now on formulary" message is Code exempt but only if there are no therapeutic messages of any kind -- a communication of limited value to physicians in the company's view.

    To minimize the lag of several weeks, is it possible for the company to submit a revised ad (stating 'now on formulary in province x') for PAAB review on a conditional basis, conditional on ultimately obtaining that formulary listing, on much the same basis as PAAB will give pre-launch reviews conditional on monographs being accepted?

    Alternatively would it be permissible to keep running a previously approved PAAB ad adding only a banner with the wording 'now on province x formulary'?

    A message containing only "Now on Formulary" is exempt as per s6.6 of the PAAB code.

    Should you wish to go beyond this exempt messaging, it is indeed possible to submit an ad prior to inclusion on the formulary. Consider the two following potential scenarios:

    • If specific criteria are not mentioned in the ad (e.g. unrestricted formulary status), we can approve it with the understanding that it will not be disseminated until such time that the formulary message is reflective of the coverage status for all available dosage forms of that product (or reflective of the status for the dosage forms specified within the claim).
    • If the ad mentions the coverage criteria, we will await official formulary documentation to review the formulary message itself; however, the review of the remainder of the ad and the context may still be initiated prior to commencement of coverage. Review of the official formulary documentation is required to ensure that the advertising message adequately reflects the coverage criteria.

    Addition of the banner “now on province x formulary” to an existing piece may be considered an “FYI” which would not require PAAB review. This assessment is made on a case-by-case basis. The following 3 conditions are required for this type of post-approval change to even be considered for assessment as an "FYI":

    • The APS to which the content is added is still within the one year PAAB pre-clearance period.
    • The content added to this existing piece does not include additional text beyond “now on province x formulary” (or equivalent).
    • The added banner is separate and distinct from the other APS messaging (e.g. a Nabisco).

    Situations in which a message of “now on province x formulary” in a currently approved APS is changed to “now on province Y formulary” can be considered an FYI.

    As a final note, exceptional circumstances may warrant a request for expedited review of formulary messages. We do our best to accommodate such requests when doing so would be in the best interest of patients (e.g. announcement of newly covered medication or communication of a safety issue regarding the sponsor’s medication).

    Please do not hesitate to call the PAAB office if you have any further questions on this matter.

  225. When is the time one can submit a docket before the Holidays? Are you open between Christmas and New Year’s? If so, do you accept submissions at this time?

    Also, does the rule of 2 for initial docket submission still apply? Is the queue always 10 days for every first submission within that docket?

    As our submission process is fully electronic, you may submit new dockets at any time, day or night. The eFile system is fully operational 24/7. The PAAB office will be closed for the holidays on Friday Dec. 24, 2010 at noon and will reopen for business on Monday Jan. 3, 2011. The last day to submit a new eFile in order to ensure a first response before we close on the 24th, is Dec. 10, 2010.

    With respect to the "rule of 2 for initial docket submissions", I believe you are referring to pre-NOC submissions. You can submit up to 2 Pre-NOC pieces for review, as long as the monograph is at "FINAL DRAFT stage" with Health Canada. Pre-NOC pieces are not bound by the 10 day timeline for first response. For more information regarding pre-NOC submissions, please refer to the document "Administrative Guideline for the review of Pre-NOC advertising submissions" on the PAAB website

    There is no limit to the number of submissions you can make at any one time for APS promoting products/indications that have Health Canada approval. The PAAB will provide a first response within 10 business days. However, the timeline for response for Direct To Consumer pieces and Opinion requests is 4 business days.

    Please call the PAAB office if you have any further questions.

  226. Les publicités de produits pharmaceutiques dans les médias spécialisés (revue médicales, associations professionnelles en santé) doivent-elles être accompagnées d'une monographie ?

    Oui selon les sections 6.1 et 7.3 du code CCPP, les publicités de produits pharmaceutiques contenant des allégations de produits doivent être accompagnés par les renseignements posologiques. Notez que les renseignements posologiques ne sont pas exigé pour:

    • les systèmes publicitaires et promotionnels (SPP) de rappel (section 7.4)
    • les systèmes publicitaires et promotionnels (SPP) institutionnels (section 7.5)
    • les systèmes publicitaires et promotionnels (SPP) rédactionnels (section 7.6)
    • les messages pour lesquels les exemptions à l’examen du CCPP s'appliquent (section 6.6)
  227. Is it permissible to give patients that have registered for an online patient support program, incentives or rewards to maintain their registered status? This is a DIN protected, branded site, that patients have registered and opted in to receive communications.

    PAAB Code s2.5 covers activities that would compromise the ethics of health care professionals. The PAAB Code does not address the issue of patient incentives directly. Keep in mind that access to gifts is a provincial pharmacy act issue regarding incentives. You would therefore need to check with the individual provincial Pharmacy Acts (or perhaps NAPRA can be one stop for all) and the Rx&D Code of Conduct. We suggest to proceed with caution as giving gifts has been a troublesome activity for pharmaceutical companies in the past.

  228. If we are providing co-pay assistance program through a third-party, do communications informing physicians/HCP of the program have to go through PAAB?

    PAAB Code section 6.6(d) allows a review exemption for formulary announcements such as "now on formulary" not linked to a therapeutic message in any way. Covered uses are deemed to be therapeutic messages. Generally co-pay assistance programs would mention a drug and a therapeutic use and would fall under Code s7.5 "Institutional" messages with product mention which would require review. The co-pay message could be part of a product ad with claims s7.3, and that requires a review.

  229. Can a pharmaceutical company have an SMS text message medication reminder sign-up on a DIN-protected website where patients can sign up for a daily SMS reminder to take their medication?

    Yes, a SMS reminder to take the medication is acceptable when a patient signs-up to participate in such program on a DIN protected patient website. Note that this site would require PAAB approval. As part of the approval process, we would require to review the SMS message wording.
    There should be a mechanism to ensure that the person receiving the SMS is still on the product (i.e. he/she is still a "patient"). For example, simple instructions on how to discontinue SMS reminders should be provided.

  230. If we place an ad in an HCP-focused journal, and provide a link to an HCP-focused website (either typed in or scanned using a 2-D scan code), can we assume that the audience has been sufficiently vetted as HCPs and provide branded drug information to them?

    This would be in lieu of asking for licence numbers or other means of identification.

    For prescription products and for drugs indicated to treat/cure Schedule A diseases, a gate of some sort is required to pose a true barrier restricting consumers from having access to the site. The relevant legislative authority is Section C.01.044 of the FDR and Section 3 of the FDA.

    The assumption in your question is only valid if the website is not searchable. In other words, the website could only be accessible to those who use the scan code or type that specific URL into the search field. Please call if you have any questions.

  231. With regard to a diagnostic manufacturing company that manufactures glucose meters, etc. The company produces detail aids, etc. Do these detail aids require PAAB approval?

    Advertising tools exclusively discussing items which have been approved by Health Canada as "medical devices" do not fall under the scope of the PAAB code. However, the piece should be submitted to PAAB if there is any mention of a drug product (i.e. DIN, NPN, DIN-HM, and Schedule C and D products).

  232. In your answer to Question 137, you are saying that although it goes beyond name, price & quantity, the PM (in its entirety)is not considered advertising. So is it acceptable to link the PM to the banner ad in the consumer realm?

    No. Because the product monograph contains content which goes beyond the name, price & quantity restriction, it may not be linked to advertising (e.g. a banner ad). For the product monograph not to be considered "advertising" it must be complete/unchanged AND it must not be linked to advertising (e.g. a banner ad). Health Canada had confirmed that linking the product monograph to a banner ad in a consumer realm would contravene C.01.044 of the Food and Drugs Regulations. Please call Patrick at the PAAB if you have further questions about this.

  233. Would there be an issue with an online banner ad that is exempt from PAAB review linking through to a PDF of the products' Product Monograph?

    I will assume that the proposed banner meets exemption criteria 6.6.d (e.g. a name-only ad). There should not be an issue linking such banner to the complete/unedited product monograph in a website gated for health care professionals.

    In a non-gated site (i.e. accessible to consumers), linking the product monograph for a prescription drug to advertising for that product would contravene section C.01.044 of the Food and Drugs Regulations (even if the ad itself does not go beyond name, price, and quantity). It is important to note that although the complete/unedited product monograph does indeed go beyond the name/price/quantity, it is not considered advertising unless it is somehow linked to advertising. Please call the PAAB office if you need further guidance on this matter.

  234. I would like to ask if my blog which contains plenty of pharmaceutical advertisements, matches with the code of ethics in Canada. On the other hand, could I add the logo of PAAB to my blog if approved.

    This is a question about a specific site. The answer cannot go on this website. You will need to do a submission or call PAAB to speak to Ray.

  235. I am developing a web site to host presentations of specialists to family physicians. The website will be gated to only allow physicians and the presentations will be accredited by the College of Family Physicians and produced independently by the speaker. There will be space for physicians' comments as well discussion forums focussed around the the topics being presented. I will seek pharma sponsorship of the presentations and will declare the sponsorship on the pages where members access the presentations. Will the slides require PAAB approval and do you see any hurdles that I may face in this endeavour?

    The answer to your question lies within whether this web site will fall within the "advertising" realm or not. If it falls within the advertising realm, then the drug advertising regulations will apply and the site should be submitted to PAAB. Otherwise the drug advertising regulations would not apply and the site would be exempt from PAAB review.

    Unfortunately, it is not possible to provide a specific answer your question as it is missing elements which must be considered in determining whether the scenario falls within the advertising realm. For example: who is setting up the site (i.e. who is "I"?), what relation do you have to the topics and sponsors, will branded advertising appear anywhere on the site? These questions in addition to a few more appear on the following link within the Health Canada policy document "The Distinction Between Advertising and Other Activities". See the link below:
    www.hc-sc.gc.ca/

    Answer all 7 questions found within this link in a manner which is objective and remember that no one factor in itself will determine whether or not a particular message is advertising. The answers must be taken as a whole.

    Alternatively, we can provide an opinion as to whether your specific scenario falls within the advertising realm if you submit such request through our electronic submission system. Please call the PAAB office if you have any further questions.

  236. I'm puzzled by an ad on the cover of a specialist journal, announcing that a product is now availabile in Canada. There are no other claims or description of the product, other than suggesting the physician call the pharma company for more information or samples.

    I'm puzzled becuase the ad has no balance copy, no warnings, and has not been PAABed; there is no prescribing information. The company must feel that the ad falls out of the scope of the PAAB Code, but i don't see any of the exemptions applying. Plus, launch is a time when MDs are particularly in need of info regarding safety information. The masthead says that all drug ads have been cleared by PAAB, but this is clearly not the case. Is there something I am missing?

    Advertising conveying no claims other than the commercial message that the product is now available is exempt from PAAB review under PAAB code s6.6.d (use of drug name only in a context not linked to a therapeutic message in any way). Please call me at the PAAB office if you have any questions about this answer.

  237. Can a non-gated medical journal web site, whose online advertising is restricted to reminder ads and non-pharma ads, offer unrestricted access to a complete digital version of back issues of the journal (Rx advertising would appear as it does in print)?

    The Rx drug advertising on a non-specialized medical journal may appear on a non-gated website if the Rx drug advertising does not go beyond the name/price/quantity restriction relating to consumer advertising of prescription drugs (i.e. Section C.01.004 of the Food & Drug Regulations). Ensure that this is also the case for back-issues unless they will be gated. The appearance of name-only ads in a specialty medical journal (e.g. Journal of Psychiatry, Journal of Urology...) conveys the message that the drugs are for a condition relating to that specialty. Those ads would therefore exceed the aforementioned C.01.004 restrictions. Also note that "reminder ads" can mean different things in different contexts. In the PAAB code for example, a reminder ad would contain the product's indication. A "reminder ad" of this nature should not be accessible to the general public as this would also exceed the aforementioned C.01.004 restrictions (regardless of the type of journal). This is different from the way in which the term "reminder ad" is used in a DTC context (i.e. name/price/quantity).

  238. A variation to question #89. An international speaker has been asked to make a presentation to a Canadian meeting of healthcare professionals about a product which has recently received its NOC. Her talk is not accredited, or about the disease category, but is focussed on the product itself which is mentioned by brand name. The slides, which are not printed out for distribution at the meeting but used onscreen, are prepared by the speaker and not by the sponsor. Do the slides require PAAB preclearance?

    In this scenario, the meeting would be a product promotional meeting and the speaker is acting on behalf of the company to promote their product. The company has picked the topic and speaker and probably the target audience, so it would fall far short of CME accreditation standards.

    Thus, the speaker would be acting like an agency does when it creates a journal ad for the company except there is no physical distribution involved. The speaker would be providing what the company wants. All of the rules of "advertising" would apply, so the company should brief the speaker about Canadian regulations and the PAAB Code of Advertising Acceptance. With respect to review by the PAAB, the Code calls for review of materials prepared with company control and distribution to health professionals. If the company gave the speaker the slides they would require PAAB review. In this scenario, the activity is a promotional meeting and review of the slides is not covered by the PAAB Code. The PAAB would review them if asked. In any event, Prescribing Information should be available for distribution at the meeting.

  239. I have a question about the permissibility of the phrase "treatment-free" within the following context. If we are promoting a type of treatment with product X, where the patient takes product X for 2 weeks and then does not have to take the medication again until 50 weeks later (i.e. the following year), would we be allowed to say that the patient was treatment-free for those 50 weeks. Product X has a short half-life and is out of the patient's system within 24 hours so the patient would not be receiving treatment for those 50 weeks. Other treatments for the same disease are weekly or monthly, thus discussing the "treatment-free" portion of the treatment regimen is a point we would like to discuss with HCP and patients.

    The product's TMA will need to be considered to answer this question. It would appear that the patient is still being "treated" even between dosing periods. Also note that some drugs are cleared from the blood quickly (i.e. short half-life) yet the treatment effect lasts a very long time (e.g. some drugs remain bound to the receptor at the active site for a long time). It appears that "dose-free period" may convey your desired message in an acceptable manner. Please call me at the PAAB office such that I can consider this specific case.

  240. For a DTC help-seeking message for a preventative product (e.g. vaccine), can the name of the manufaturer appear on the ad?

    In the case of DTC messaging for preventative, non-prescription products (e.g. vaccine), the name of manufacturer may appear on the ad. In fact, section A.01.067 allows certain non-Rx drugs and NHPs to make prevention claims for schedule A diseases in advertising directed toward consumers. It may even be branded for the product; in such a case, the message will be considered to be promotional and advertising regulations would apply (e.g. please refer to the Health Canada Interim Guidance "Fair Balance in Direct to Consumer Advertising of Vaccines").

    Please note that this is not be confused with DTC messaging for prescription drugs or treatment of schedule A diseases. For these, the Health Canada guidance document "Distinction Between Advertising and Other Activities" applies and there should be no mention of the product or corporate name on the help-seeking message.

    Please call the PAAB office if you have any questions about this.

  241. Can sales representatives distribute Congress reports? The congress reports are commissioned by a pharma company to a third party ( ex medical communications company). Information is not focussed on company brands and is balanced and independently produced.Do these reports need to go to PAAB for reps to be able to distribute?

    Please see PAAB Code s11.1 for the definition of advertising subject to the Code and see PAAB Code s6.6(a) that states "Information materials that have been independently controlled and prepared, with industry involvement limited to purchase and/or sponsorship of the distribution (example: a textbook)."

    Meeting Reports of sections of accredited Health Professional Meetings or Continuing Education (CE) events/activities (see s11.10) organized independently of the sponsor of the materials and that are not focused on, or provide emphasis on, the sponsor's product(s) i.e. do not promote the sale of the sponsor's product(s).

    See Health Canada guideline "The Distinction Between Advertising and Other Activities" regarding section "Continuing Medical Education (CME) / Scientific Symposia/Exhibits" that states "Moreover, reports, edited scripts or recorded videos of the proceedings, in whole or in part, that concern a specific drug may be advertising if they are disseminated by the sponsor, or the sponsor's agent, to a wider audience after the meeting."

    Based on the above, if the content includes statements, claims or data relative to the drugs that the sales reps normally promote, the item would be considered "advertising" subject to PAAB review. See section 1 Scope. Sales reps are hired to promote the sale of a product. Therefore, just about anything they hand out would be considered to be advertising by the definition in the Food & Drugs Act.

    You can see the PAAB Code at www.paab.ca

  242. We are considering creating a web site that is for healthcare professionals (HCP)only. What are the minimum requirements for 'gating' the site? As this may span multiple products, DIN is not appropriate. We will be looking to use a UserID/Password combo. What is our responsibility as a pharmaceutical company to ensure that the person signing up for an account is indeed a HCP? Can it be as simple as getting the HCP to agree to the 'Terms of Use'?

    For prescription products and for drugs indicated to treat/cure Schedule A diseases, the gate is required to pose a true barrier restricting consumers from having access to the site. The relevant legislative authority is Section C.01.044 of the FDR and Section 3 of the FDA. Simply indicating an agreement to the “terms of use” (e.g. “I confirm that I am an HCP”) would not appear to meet the requirement as this would not pose a true barrier to entry for non-HCP audiences. This does not show intent to restrict the messaging to HCPs.

    There are various ways to successfully gate a site. Many clients meet the gating requirement through passwords provided to the HCPs, but there are other options as well. For example, some sites are not accessible except through a link emailed to the HCP or a disk provided to the HCP which takes them into the site. As these ‘access keys’ are distributed only to the HCP on the front end, there is no need to have a password on the site (unless there are other ways to get to the site). We are aware that there are various uses of technology to provide effective gates. We recommend consulting an e-supplier. The PAAB will review the landing page to ensure that it meets the DTC requirements.

    Note that for non-Rx Products which are NOT indicated to treat/cure Schedule A diseases, a gate is not required. Please call the PAAB office if you have further questions regarding gating websites.

  243. On the website: http://fightosteoporosis.ca/ the copyright notice says: "Copyright C 2010 A research based pharmaceutical company"

    This doesn't seem right to me, I would expect a copyright notice to clearly state the site's owners. Investigation shows that the site is operated by Warner Chilcott (who market Actonel) but a lot of digging is necessary to get that information.

    Is this on-side with PAAB regulations?

    This is a direct-to-consumer activity that contains a legal issue that is beyond the PAAB Code. Health Canada has a policy, “The Distinction Between Advertising and Other Activities”, see http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/index-eng.php regarding Help-Seeking ads that you can see on their web-site. As a requirement to meet the law, you cannot identify a company name. Other companies have tried identifying their company through the copyright line and were told by HC that that did not meet the legal requirement. The PAAB offers a four day trurnaround opinion review service for Direct-to-Consumer advertising and disease information web-sites that helps keep companies out of trouble.

  244. If a product that has NOC (i.e., without conditions) but does have a black box warning, how prominent do the indication statement and black box warning need to be? We would like to include both in the fair balance section of the piece, but wonder if either text needs to be placed elsewhere in the piece as well.

    Generally, the black box warning can appear with your fair balance block. Note that this warning must appear within a black box in the ad in order to reflect the PM. Also note that there are situations in which the warning is required to be repositioned. Consider, for example, a scenario in which the black box speaks to the importance of closely monitoring for drug interactions when the sponsor’s drug is used in combination with Drug ABC. If the APS in this hypothetical scenario were to contain a claim depicting efficacy results for a protocol combining the sponsor’s drug with drug ABC, we would require that the warning appear prominently on the same page as this claim.

    Generally, the indication may appear with the fair balance block. However, there are situations in which the indication is required to be repositioned.
    For example, the indication should appear near the beginning of the ads at product launch.

    For NOC/c products, please refer to the guidance on our website at www.paab.ca
    For more specific questions/scenarios, please call the PAAB office.

  245. Most brands have quite lengthy balance and we are looking on how to incorporate this into banner ads that include product claims. If the banners are animated and they rotate/transition automatically from claims to balance, is that okay. This would be the same as turning pages in a detail aid....correct?

    It is acceptable to use Rx banner ads which transition/rotate automatically between claim page and balance page within a gated website. Such banners for Rx products should not be accessible to consumers as this would go beyond the name/price/quantity restriction (FDR C.01.044). Please ensure that the slides rotate at a pace which permits the balance slide to be read within a single rotation. This is important given that fair balance is required to be prominent as per PAAB code sections 2.1.2 & 2.4 & 3.5. With regards to length of fair balance, you can ask the PAAB reviewer whether there are any segments of fair balance which can be removed or revised. This may be possible depending on the product’s Terms of Market Authorization and the quantity/type of claim copy. Also ensure that there is a link to the Product Information (PI) or Product Monograph as discussed in Q&A #111. Please call the PAAB office if you have any questions.

  246. Can we use the same visual/design for a new product launch that was used pre-NOC in editorial pieces? The visual/design has not been used in other countries or jurisdictions so not linked to any product.

    Once the product is approved, the manufacturer may continue to use the same visuals/colours from prior editorial pieces in branded APS ONLY if the pre-NOC content falls within the limitations of the approved product’s Terms of Market Authorization (TMA). Otherwise, using the same visuals/colours would link the product to disease information which extends beyond the limitations of the TMA thus contravening PAAB code section 3.1 and possibly the Food and Drugs Act section 9.1.

    The PAAB urges pharma companies to approach the decision to use future branding elements in pre-NOC unbranded pieces with caution as the final TMA is not known with certainty prior to product approval. It is possible that you may not be able to use visuals post-NOC if they were used in pre-NOC pieces that contained disease information or content which extends beyond the limitations of the final/approved TMA (e.g. due to unforeseen revisions requested for the PM). If the pharmaceutical company is uncomfortable with this possibility, we would advise against using the planned future branding visuals within pre-NOC APS.

    Note that use of visuals/designs prior to NOC which already exist in other jurisdictions in association with the brand would appear to be an indirect promotion of an unapproved product. This would contravene section c.08.002 of the Food and Drug Regulations.

    See question & answer #102 for discussion on acceptable pre-NOC content and see Q&A #107 for discussion on acceptable references in pre-NOC pieces. Call the PAAB office if you have specific questions about pre-NOC APS.

  247. We were wondering whether there are potential issues with using the same patient visuals across both healthcare practitioner and patient materials. The patient materials would be mainly patient information pieces for those who are already on the drug.

    PAAB Code s. 6.4.3 requires that patient material be non-promotional. The same visuals can be used in branded HCP pieces and branded patient pieces provided that the visuals do not carry a promotional message. PAAB considers context when assessing visuals in any APS and the intended audience is an important part of that context.

    When employing the same visuals across several pieces, it is important to be cautious not to link branded and non-branded pieces. Such linkage would inherently brand the unbranded content.

  248. If a pharma company with an OTC or BTC product creates a private branded website that is password protected and accessible only by physicians, it is understood that all company generated content on the site would be subject to PAAB review and approval.

    However, if the site also allows for user generated content such as discussions between physicians, physician blog posts, or other physician generated questions or commentary, how might this type of dynamic activity and content be viewed by PAAB? Particularly given this type of content would be in constant evolution. Please note that this content would be viewable only by registered Canadian physicians. Any advice or direction would be appreciated.

    This answer is equally applicable to OTC, BTC, and Rx drugs. Health care professional directed drug advertising (whether prescription or non-prescription) falls within the scope of the PAAB code. In the case of social media websites, the PAAB would pre-clear the framework of the site. The framework includes any content controlled by the sponsor (including but not limited to the landing page, introductory instructions, company controlled drug & disease content, discussion thread titles/topics/questions). Although the PAAB would not require to pre-clear or review the dialogue among registrants, it is important that the sponsor monitors all content on their site including the posts/discussions. Keep in mind that although the manufacturer has forfeited some control over the message by letting the registrant post content, the manufacturer retains the regulatory risk as this is the company’s site. For example, the manufacture is expected to ensure that all information on the site is accurate despite the inherent reduction of control by the manufacturer. The need for this sort of moderating can be minimized by clearly conveying site rules at the outset. The degree of restrictions imposed would depend on the manufacturer’s comfort level regarding legal liability. Another consideration may be to employ voting functionality instead of open text fields. This would effectively limit the registrant contributions to content which the manufacturer is comfortable with. Alternatively, to reduce the legal risk, the manufacturer can consider simply sponsoring a site created and controlled independently by a third party. This would reduce the likelihood that the content falls in the advertising realm (thus reducing the likelihood that advertising regulations apply to the content on the site). It is important, however, to consider all 7 factors in the Health Canada document “The Distinction Between Advertising and Other Activities” when determining whether something falls within the advertising realm. PAAB can help you with this assessment.

    A second important reason the manufacturer should closely monitor the social components of the site is that there is an expectation that the company will report adverse reactions conveyed on the site (provided the reporter, the patient, the drug, and the event are either known or can be determined). Please visit the following Health Canada guidance document for information on adverse reporting requirements for internet sites:
    http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2009-guidance-directrice_reporting-notification/index-eng.php

    Sections C.01.016 & C.01.017 of the Food & Drugs Regulations speak to the timelines & level of priority towards different adverse reactions. If you do not desire to monitor the site for adverse drug reactions, clearly convey that registrants are not to post adverse drug reactions on the site. For example, there might be an instruction to call the medical/regulatory department instead.

    Please keep in mind that the social media area is evolving. For the most current guidances, call the PAAB office. Note that many of the regulations for internet advertising apply to the social media arena. Please see PAAB code section 6.5 regarding internet advertising.

  249. Our understanding is that not every tool needs to include extensive fair balance, but that the fair balance content can be determined by the number and weight of the claims in the piece.

    If we are submitting a dosing calculator which has no other claims other than dosing information, how would we determine which fair balance text could be eliminated? Our thought would be to include the indication statement and contraindications. Would that be enough? This is for a product that has NOC (i.e., no conditions).

    For clarity and completeness as per PAAB Code 2.1 & 2.1.2, the APS should state the product’s indication and the associated limitations. As for the fair balance requirement, we would need to see the APS in proper context (with visual and text) in order to determine what balance copy is necessary. Keep in mind that fair balance requirement is based on the number and type of claims in addition to the product monograph. The following are examples of elements which may still be required in an APS containing no claims other than dosing information:

    • contraindications
    • boxed or bolded warnings/precautions
    • dosing limitations or important safety information relevant to dosing (e.g. special populations)

    Please note that the prescribing information (PI) would also be required to accompany this piece as per PAAB Code s7.2 & 7.3. Please call the PAAB office if you have questions about the fair balance requirements on a dosing calculator for a particular product.

  250. We are considering producing a patient brochure in an alternate language other than french or english that remains valid until mid 2010 by PAAB. I understand that PAAB does not require a review if this is simply a translation and printing however in the last two months the Merck logos and trademarks have changed.

    If we change the trademarks/logos on this brochure do we require an additional review seeing as we are only changing the logos to reflect the new company name and then printing this new language which would have the same mid 2010 expiry date. Content of the brochure will not be changed.

    The PAAB should be kept aware of the current version of the ad. However, a change in corporate logo or trademarks would not necessitate a new review. We suggest sending the change as an “FYI”. This can be done by attaching the updated piece to an email referencing the original PAAB file number. The email should be sent to review@paab.ca. We will upload the updated piece into the appropriate eFile for our records. Please note that an approval response will not be provided as a full review will not be conducted. The approval expiration date for the piece will therefore remain unchanged.
    You are correct that the PAAB performs reviews in English and French. APS produced in other languages that are translated from a PAAB approved APS should not carry the PAAB logo and may include a disclaimer stating the item was translated verbatim from a PAAB approved APS.

  251. Does regulatory permit placing a link on an unbranded condition website that drives visitors to the associated corporate website? The link would direct users to the corporate home page.

    The link to the sponsor's corporate website can appear on an unbranded condition website. The PAAB would not require to review the link provided that it directs the browser to the home page. Note that the unbranded condition site requires PAAB review if it discusses drug therapy (regardless of whether the link appears on the site). It would be reviewed under PAAB code 7.6. Please call the PAAB office if you have any further questions about this.

  252. Under what circumstances would it be acceptable to use a peer-reviewed, published study for a schedule F drug if that study uses a dosing regimen for the companion drug (always prescribed together but not subject of advertising, nor manufactured by the same company) that is inconsistent with the product monograph?

    Advertising must be consistent with the sponsor product’s Terms of Market Authorization as per Food and Drugs Act section 9.1 and PAAB code section 3.1. As such, products promoted for use in combination with the sponsor’s drug should be within the sponsor’s product monograph (PM). Additionally, the dosing of that combined drug should be consistent with the PM. Please call the PAAB office if you would like an opinion on your specific case.

  253. I presently manage a small graphics studio and printing company and have been asked by one of my clients to arrange to get PAAB approval for certain Pharmaceutical Detail aids, Brochures and other related materials. I would like to know how to go about registering either my company or myself to be able to submit to PABB for approvals in the near future.

    Please call the PAAB office (905) 509-2275 and ask for Glenn Golaz. He will register you on eFiles. We register individuals on behalf of companies. Afterwards, our file coordinators can help you if you have technical questions about submitting the projects.

  254. We want to produce a sticker that will say : NEW INDICATION. This sticker will be distributed to representatives to be applied on several promotional items that have gone through the PAAB for approval. Does this sticker need to go through PAAB for approval?

    The claim “New indication” does not meet any of the PAAB exemption criteria listed in section 6.6 of the Code. The sticker would therefore require PAAB review. As part of our review, we would require to know which APS the sticker will be applied to (and where within those APS it will be applied). Please note that the PAAB would not accept addition of a sticker stating only “New indication” to APS which do not contain the new indication as this would be unclear. The pieces would be required to contain that indication. Additionally, it would need to be clear which of the indications are “new”. For scenarios in which the approved APS does not already contain the new indication, we would require that the sticker itself contain the full indication. Advertising must be accurate, complete and clear as per section 2.1 of the PAAB code. If you have any further questions about this, please call the PAAB office.

  255. Can you confirm for branded, paid search campaigns, if you're able to:

    1. Link the branded ad to both condition and brand name together as keyword terms? For example, "cholesterol Lipitor"
    2. Link the branded ad to general terms such as "corticosteroids treatment"?

    The keyword would trigger a branded text ad that would then link to a DIN-protected, branded site.

    Answer 1: Section C.01.044 of the Food and Drugs Regulations prohibits Schedule F product promotion directly to consumers beyond name, price, and quantity. As such, linking product name and condition in this manner would appear to contravene the Food & Drugs Regulations.

    Answer 2: The term “Corticosteroids treatment” would also exceed the name, price, and quantity restriction.

    Ensure that the search results, the meta data descriptor, the site URL, and/or the content visible on the splash page (prior to entry of the password) do not exceed the name/price/quantity restriction. Please call the PAAB office if you require further information.

  256. Does PAAB have any oversight on companies that advertise a system for treating periodontal disease through use of non-proprietary antibiotics among other diagnostic and treatment protocols?

    We would need more information to answer this. The answer would depend on the following:

    • What is the Federal category of the Terms of Marketing Authorization (TMA) for the medications?
    • Is the promotional material directed to health care professionals (HCPs)?
    • Is the “system” approved by Health Canada as a device?

    If the promotional material is directed to HCPs, the PAAB reviews the content irrespective of the medication’s Federal schedule (i.e. whether the product is a prescription, non-prescription, or a natural health product). If the material is directed to consumers in the waiting room, the PAAB would review the messaging for prescription drugs and schedule D drugs.

    The PAAB would not review claims about the device itself if ”the system” had been approved by Health Canada as a medical device. Please call the PAAB office if you have any questions or require further information for your specific case.

  257. We have a journal ad that will be produced in several sizes (regular, tabloid, and 5"x9") does every size need to be submitted to PAAB for review. note that the message is exactly the same only the size changes.

    If all copy, relative positioning, and relative size are identical, we can review all sizes within a single eFile. For post-approval re-sizing, the ad should be provided to PAAB as an FYI (“For Your Information”) such that we can have the various versions on record.

  258. As a private clinic we are planning to prepare advertising material to be played on TV only to the patients waiting in the waiting area. The contents of these ads will be prepared by specialists in different medical disciplines. This will mostly contain OTC, NHP products. Is this activity subject to PAAB review?

    Advertising displayed in the waiting room would be considered direct to consumer advertising. Direct to consumer advertising of OTC and NHP products fall within the jurisdiction of Advertising Standards Canada (ASC). We suggest contacting ASC at 416-961-6311 (http://www.adstandards.com/en/). Note, however, that patient information for an OTC or NHP product involving the health care professional as an intermediary would require PAAB review under code section 6.4.3.
    The PAAB provides advisory comments on vaccine and prescription direct-to-consumer advertising or information materials.

  259. If a client was to state its indication along with a logo on an electronic web banners, does it needs to be approved by PAAB? As well, does it need to have a click through to PAAB?

    The ad is required to be reviewed by the PAAB. The PAAB code section 6.6.d states that an ad containing only the drug name in a context not linked to a therapeutic message in any way is exempt. The indication would be considered a therapeutic message. I am unsure what you mean by “click through to PAAB”. I will assume you had meant “click through to the prescribing information (PI)”. Yes, a link to the PI would be required if the APS does not meet the reminder ad criteria listed in PAAB code 7.4. Also note that if the reminder ad criteria are not met, additional fair balance would be required to appear on the ad itself. If the “logo” contains a claim (whether text or visual) the ad will not meet reminder criteria. If I have misinterpreted your question, please do not hesitate to call me at the PAAB office.

  260. We would like to develop a schedule table for a multi-dose regimen of a vaccine and provide it to customers in a fridge magnet format. No product name or branding will be included, but it will be labelled as being provided as an educational service by company X. The content would be submitted for PAAB review.

    Is the fridge magnet format acceptable to PAAB?

    The PAAB reviews drug advertising content. We do not rule on marketing practices. We have previously approved advertising messages on fridge magnets. Pease note that a product’s dosing information is considered claim copy. It will be required to be consistent with that product’s terms of marketing authorization (TMA) and it should be accompanied by the indication and balancing information.
    Prior to considering providing items as a giveaway, we strongly urge you to check with the Rx&D Code of Ethical Practices s11. We have a link to Rx&D on our website (www.paab.ca/).

  261. Under the current system, PAAB surveys are sent to the administrative staff who perform the work of submitting efiles. Can they be directed to the creative staff who perform the work of writing and responding to the letters?

    The Customer Experience Index surveys are sent by automated software in a random manner and are anonymous to PAAB personnel. For ease of administration they are sent to the admin staff who initiated the eFile. However, there is no reason why the firm receiving the survey cannot pass it on to whomever they deem it best to complete the survey. The PAAB requests an answer from the person or group of people who had the most experience on the particular file in question.

  262. The PAAB code says that we cannot refer to Health Canada or the approval process for drugs in our advertising, and the reasons are obvious.

    But why can't we say "for all approved indications" when a product has a number of different indications?

    Health Canada has asked the PAAB to ensure that the approval process is not discussed in drug advertising. The PAAB therefore questions the claim “approved” whether it is used in conjunction with the product name or the indications. The underlying principle is to avoid implying an endorsement for the product or its individual indications. Also note that C.01.007 of the Food and Drug Regulations states that “no reference, direct or indirect, to the Act or to the Regulations shall be made … in any advertisement for a drug unless such reference is a specific requirement of the Act or Regulations”.
    Have you considered simply “for all indications” or “for all authorized indications” (i.e. given that they stem from the Terms of Marketing Authorization)? Please call the PAAB office if you desire more direction on your particular claim.

  263. For a launch product is the review time the same as an old product line. When a pharmaceutical submits to PAAB the promotional pieces needed at NoC does PAAB take their 10 full days for review or is it possible to take half of the time because it is a product in launch mode.

    Our mandate is to provide our initial comments within ten working days of receipt of all required materials (e.g. the advertisement & the supportive information). However, we make every effort possible to try to provide this first response within less than 10 working days. In fact, so far in 2009, approximately 60% of all first responses were provided in less than 10 working days.
    For the sake of fairness, on a policy level, we do not differentiate between the timelines for newly approved products and “old products”. We do our best, however, to accommodate rush-requests when they are unlikely to affect the timelines for other projects. The PAAB is aware of the time crunch our clients face during product launches. This is why we have an “Administrative Guideline for the Review of Pre-NOC Advertising Submissions” posted on our website (www.paab.ca). If requested, we will begin to review a maximum of two core pieces prior to receipt of NOC provided that the product monograph is at final draft stage. This is meant to give the manufacturer a head-start in determining the approvability of core messaging. You are invited to refer to the complete guideline on the PAAB website. Note that since our mandate is to approve advertising for NOC products, you might not receive first response within 10 working days for pre-NOC submissions.

  264. If the US indication is the same as the Canadian one, but the US Product Monograph is more comprehensive can it be cited instead?

    PAAB Code section 3.1 states that all claims must be consistent with, and within the limitations of, the Health Canada approved Terms of Market Authorization (TMA) (e.g. product monograph). The US FDA approved Product Monograph would not meet that requirement even if the product’s indication is similar in Canada. Question #56 may also be of interest as it is similar to this current question.

  265. Je travaille pour une agence de publicité et nous devons préparer un lancement de produit pour un produit pharmaceutique en vente libre, sous restriction, behind the counter (annexe II).

    J'aimerais svp avoir les réglèments publicitaires à respecter pour chacune des provinces.

    Les règlements de publicité sont fédéraux et s'appliquent donc à toutes les provinces car ils proviennent du loi sur les aliments et drogues. La section 9.(1) de la loi sur les aliments et drogues est au coeur des règlements de publicité de drogue. Elle énonce:
    « Il est interdit … de vendre une drogue — ou d’en faire la publicité — d’une manière fausse, trompeuse ou mensongère ou susceptible de créer une fausse impression quant à sa nature, sa valeur, sa quantité, sa composition, ses avantages ou sa sûreté. »

    La loi ne fournit pas actuellement beaucoup de détail au sujet de comment ne pas tromper. Cependant, le code d'agrément de la publicité du CCPP est un guide utile pour empêcher la publicité trompeuse de la publicité des produits de santé dirigé vers les professionnels de santé. Les produits de santé incluent les produits pharmaceutiques, les agents biologiques et les produits de santé naturels [11,3], qu’ils soient simples ou composés, vendus sur ordonnance ou en vente libre. Vous êtes encouragé de soumettre les publicités dirigé vers les professionnels de santé au CCPP.

    Le CCPP et le NCP offre un service consultatif relativement aux activités promotionnelles s’adressant directement aux consommateurs et portant sur les produits pharmaceutiques vendus sur ordonnance et des agents biologiques (les produit sur l’annexe F et D).

    Le NCP et MIJO fournissent des revues d’agrément préalable pour les activités promotionnelles s’adressant directement aux consommateurs et portant sur les produit a vente libre.

    En lançant un produit, rappelez-vous qu’Il est interdit d'annoncer une drogue nouvelle à moins que la drogue nouvelle a reçu un avis de conformité (section C.08.002 des règlements sur les aliments et drogues).

  266. If a disease education piece is being submitted (pre-NOC) that contains no branding and no mention of drug or treatment, would a review paper be an acceptable reference?

    PAAB code 3.1.1 states that “Review articles… are generally regarded as not being high-level evidence to support claims in drug advertising”. Having said this, there should be no drug claims in a pre-NOC editorial APS as per PAAB code 7.6.1.

    The PAAB will consider review papers, provided they are published and peer-reviewed, as support for discussion of physiology & pathophysiology content within pre-NOC editorials. This latitude is provided as the science pertaining to the receptor or the metabolic pathway is likely to be new and thus unlikely to have already been incorporated into guidelines and/or textbooks. However, review papers are not acceptable sources of support for messages regarding current medical opinion or practice. Such messages should be supported by Canadian consensus guidelines or authoritative medical textbooks. It is also important to note that the PAAB will question any reference which appears to promote the pre-NOC drug (or its product code) as this could be considered indirect promotion of a drug prior to NOC, which would contravene Section C.08.002 of the Food and Drug Regulations. Please call the PAAB office if you have questions about specific references or pre-NOC editorial content.

  267. If we have a non-branded poster, talking about a disease and with a call to action: talk to your doctor. This poster will be given to the secretary of the doctor's office by the pharmaceutical representative and then will be posted in the examining room. Is this subject to PAAB review?

    Also with the poster there will be a booklet disease oriented for patients also to be given to secretary to be left in the examining room. Is this subject to PAAB review?

    With that poster there will be a card to be given to the patient by the doctor with the same message and a call to action (talk to your doctor) is this also subject to PAAB review?

    The PAAB generally reviews APS which discuss drug therapy. Product branded and unbranded service oriented vehicles such as posters intended for the examination room and cards/brochures intended to be distributed to patients through health care professionals are reviewed under PAAB code s6.4. Note that the absence of product branding would not, in of itself, render an APS exempt. You may refer to PAAB code 6.6 for exemptions. If you would like further information about your specific pieces, please call the PAAB office.

  268. Can a pharmaceutical company provide ,upon request from a Third party HCP controlled website, a company produced educational slide deck ( disease and treatment) that has not been reviewed and approved by PAAB.

    The third party website wishes to provide these educational slide kits to their members as self learning resources.

    PAAB code 6.6 lists what is exempt from PAAB review. This slide deck was created by a pharmaceutical company and it contains discussion on drug treatment. As such, it should be submitted for PAAB review if it will be distributed beyond the context of person-to-person correspondences (i.e. beyond responses to an unsolicited request for this specific material). Note that the scenario outlined in your question does not meet the exemption for person-to-person correspondences as such communications should be for the individual’s personal use. This is consistent with Health Canada’s policy on unsolicited requests for information as per the document “The Distinction Between Advertising and Other Activities”. The following is an excerpt from that document:

      Information provided to an individual about a drug treatment(s) by a pharmaceutical manufacturer in response to a request for information that has not been solicited in any way (by the manufacturer of the drug) is not considered to be advertising for the sale of a drug.

    Note that the third party site may mention that members can contact a pharmaceutical company’s medical information department to make specific requests for information. The availability of this specific slide kit should not be mentioned on the site as the ensuing requests would not be considered "unsolicited".
    Company-generated editorial material is reviewed under section 7.6 of the PAAB code. Please call the PAAB office if you have further questions about exemptions

  269. Can you please clarify the relationship between the placement of balancing information and a product logo?

    It is unclear as to why the product logo must signify the 'end' of the main advertising message.


    Section 9(1) of the Food and Drugs Act states that "No person shall ... advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety”. Emphasizing the benefits of a drug without also emphasizing the risks can be viewed as misleading.
    The PAAB code requires that fair balance be presented prominently within the “advertising message portion” of the ad (PAAB s2.1.2). PAAB code 11.2 defines this as the main body copy containing claims and promotional messages. The principle here is that risks should not be conveyed in a manner suggesting that they are of secondary importance to the benefits.
    Positioning contributes to prominence. The fair balance should generally appear above the product logo as the main promotional messages typically appear above the product logo. It is important to note that this is not always the case. For example, there are situations in which the product logo appears in the middle of the main body copy containing claims. In such situations, the logo clearly does not mark the end of the main advertising message. Also keep in mind, that the PAAB considers several factors when assessing fair balance prominence. These include the ad content, the relative type size of the fair balance (along with font type, font style, and font effects), and the fair balance positioning in the ad. No single factor necessarily determines the acceptability of the overall prominence. For example, it is possible for font size/type/style/effect to compensate for non-ideal positioning. I suggest calling the PAAB office if you would like to discuss a specific case.

  270. Are all promotional materials for health care professionals for natural health products required to have PAAB approval? or is this a voluntary action?


    Section One Scope of the PAAB Code of Advertising Acceptance includes the review of advertising of Natural Health Products to health care professionals. The PAAB Code is a voluntary code supported by the major pharmaceutical industry trade associations and endorsed by Health Canada which has ultimate legal authority for drug advertising in Canada. If companies choose not to come to the PAAB and the PAAB receives complaints about their advertising, the PAAB will ask Health Canada to intervene. The PAAB endeavours to make the unique Canadian healthcare product advertising self-regulation system work for all companies in the best interest of Canadian patients.

  271. Does PAAB have specific rules regarding Pre-NOC communications

    Are you allowed to send out a pre-NOC communication that focuses on the disease, patients current unmet need and that a new option for treatment is coming soon?

    PAAB has had a guidance on pre-NOC review of communications since 2003. It is posted on the PAAB web-site www.paab.ca. This type of message usually falls into “editorial” advertising and you should refer to Code s7.6 and the second paragraph of 7.6.1. Federal law and PAAB code section 3.1 prohibits advertising of a health product prior to Health Canada approval for marketing. Therefore, you cannot point to a “new option” or any other wording that depicts a specific product. You can speak to the disease and to some degree “patient’s unmet needs” but not if it is disparaging to current therapy or points at a specific alternative. For new projects, I suggest calling the PAAB office and ask for a verbal opinion at no charge regarding the need for PAAB review.

  272. Do you have an example of how to write an APS? What I am allowed to exclude from the PI?

    Regarding “how to write an APS”, we leave the creative process to professional advertising agencies. There is no “one way” to do that. The PAAB provides a regulatory review based on the PAAB Code of Advertising Acceptance available at www.paab.ca. The types of APS are included in s6 of the code. The PAAB Code is a minimum standard that encompasses regulatory, scientific, clinical and ethical principles. Please see Code section 7 regarding Product Information (PI) requirements and in particular s7.3 for full details on PI requirements for product advertising with claims. You can also see the Product Information style guide on the PAAB website under “resources”. You have to follow the format for journal advertising and you have to include the content of the product monograph within the format requirement. You can exclude content that is mentioned more than once, meaning one mention in the PI is enough. You can exclude extraneous wording that does not give specific direction to health professionals. For example, there may be several paragraphs talking about an effect on mice and you need only include the content related to the direction for human use. This occurs often in regards to pregnancy when the conclusive statement “don’t use in pregnant women” is enough wording to express the safety issue instead of the several paragraphs about what happened in mice. You can also do style edits to remove space-consuming charts and put them linearly. Basically you can reduce the space required for PI considerably if you follow the style guide and do proper editing. Health Canada has no objection to the PI style format in the PAAB code. For APS other than journal ads, the full product monograph or package insert can be distributed with all APS. Please note that the distribution of PI is a legal requirement consistent with s9(1) of the Food & Drugs Act.

  273. Is there a current practice to use a symbol "PR" to designate a prescription drug, like in trade-marks where the symbols "TM" or (R) are used ? And if so, what are the rules of use for such symbol?

    As per PAAB Code 2.2, the federal drug schedule (e.g. Pr for prescription products) in addition to the brand and generic names of the product must appear in juxtaposition as least once in both the advertising copy and prescribing information.

  274. Is it possible to include any brand/company logo to media materials such as a press release or fact sheet?

    Press releases to the public should be nonpromotional and thus, are exempt from PAAB review, and you should avoid conflicting with the federal Direct-to-Consumer advertising regulations. Please refer to the Health Canada guidance document “The Distinction Between Advertising and Other Activities” for the section titled "Press Releases/Press conferences". It is available at http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/actv_promo_vs_info-eng.php It gives criteria when a press release is nonpromotional and therefore not subject to advertising regulations. The company logo would be fine in most cases. The brand logo may be questioned if other elements appear to make the document promotional of a particular drug. Branding is seen as a promotional activity and we would recommend not using the brand logo if the intent is to make a nonpromotional press release.

  275. Pourquoi ce site web: http://cavabiencavamal.ca/index_fr.html n'a pas l'approbation du PAAB. Est-ce que les sites web ne comptent pas comme un médias? De plus, il n'y a pas la mention de qui sponsor le site,ce ne serait-il pas contraire à l'article 6.5.2?

    Le CCPP ne répondra pas aux questions spécifiques au produit, l'entreprise ou les individus dans ce forum public. S'il vous plaît appeler notre bureau à 905-509-2275 pour demander à notre Chef Réviseur Patrick Massad de répondre à votre question. Le but de ce forum est de discuter l'application du Code d'agrément de la publicité quant aux problèmes ou scénarios généraux.

  276. Would a card describing the Ontario Drug Reimbursement process (codes, who to contact, etc) for a drug be PAAB exempt?

    Example - Title might say "Reimbursement of [drug class] including drugX".

    Drug logo (no tagline) included.

    Yes, this item would require PAAB review under code section 7.5 i.e. institutional message with product mention. Please note that if you only say “Now on Formulary” and nothing else, it is exempt (s6.6).

  277. As follow-up to question 91 and as referenced in question and answer 46, if the off-label content of the educational material (publication) is not the focus and will not be discussed by the rep, and that the reps are trained to use the material in a non-promotional manner, would this then comply to PAAB exemption?

    You appear to be trying to create a grey area. The issue that you have to address is “Are you ‘advertising’ your product by the use of this material?”. The definition of advertising includes “promote the sale of a product”. If you are using the “educational” (no such designation exists in the regulations) material to promote the sale of your product then you are advertising. Health Canada has a guidance that says that if you link advertising and non-advertising materials then all of it becomes advertising. I suggest to stay away from the perception of promoting off-label information. There must be a valid source of information regarding the on label stuff if it found its way into the “educational” material. Many companies are setting policies to not let their sales reps distribute materials that are not intended for promotional use for perception and control reasons.

  278. I have a question regarding minimum font size for safety and balancing copy. It is clear in the PAAB code that it is required to be 75% of the main claim in size. The reasons for this are obvious if one is producing a journal ad or printed piece - the balance copy must be legible.

    However, if the APS is a 10 foot high panel, does the same ratio apply? In such a case, the balancing copy is almost beyond legible (too big) and consumes the entire bottom of the panel.

    I am not aware of the 75% requirement being in the PAAB code. There is a requirement that advertising be accurate, complete and clear and contain fair balance to not mislead (s2.1) The proportion of 75% is a guideline used by review staff to help advertisers meet that requirement for most APS reviewed at the PAAB. Therefore, for a large exhibit panel we would recommend that the type size be large enough to be legible to a reader from an appropriate standing distance i.e. if they can get close to it to read it easily then it does not have to be 75% of the main body copy. It would depend on the booth size and the panel location.

  279. Can sales representatives distribute educational materials that have been commissioned by their pharma company. The content of the educational material is produced by an independant expert faculty in a given disease area and content is reviewed by an University for balance & scientific integrity and endorsed as being deemed appropriate for Mainpro 2 or Section 2 credits. For reps to be able to distribute the information do the materials need to be reviewed by PAAB even though they are not promotional but rather educational?

    Terminology is important because “advertising” is federally regulated. Therefore, the material is either “advertising” or “not advertising” for regulatory purpose. There is no such category as “educational” within the terminology of the law If the material has been produced independently and is to be distributed in its entirety without additional comment or editing by the company, it is exempt from PAAB review as per code s6.6. However, because of the context of the distribution (eg: drug rep), this may still be considered to be “advertising” if there is focus on the sponsor’s product in the content. As such, we suggest ensuring that there is no off label content in violation of the PAAB Code and federal law. The sales reps should be thoroughly trained on SOP to handle this material in a non-promotional manner. We can provide an opinion if they so choose to submit for opinion. Also see the Health Canada document “ The Distinction Between Advertising and Other Activities” for the section on distribution of advertising material related to CME/Symposiums see http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/index-eng.php with reference to the section that speaks about distribution of material after the event.

  280. Does PAAB follow the US Pharma codes requirement that companies can not provide giveaways at promotional conventions as of 2009. However, for a US company that is participating in a canadian international convention that is currently licensed in the US for a particular product or use but not licensed in Canada, are giveaways at the booth appropriate, and if so what kind of giveaways are appropriate?

    This is not within the PAAB mandate or scope. PAAB Code section 2.8 covers giveaways mentioned in advertising and this is not the case in your question. The Rx&D Code of Conduct sections 7a and 11 cover distribution of gifts and service-oriented items and the PAAB encourages all companies to follow that code when marketing health care products in Canada. See http://www.canadapharma.org/. Also see the Health Canada document “ The Distinction Between Advertising and Other Activities” for the section on distribution of advertising material at international conferences see http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/index-eng.php.

  281. Would a live event whereby healthcare professionals are invited to hear key opinion leaders discuss unmet need in a therapeutic area and a drug that has just obtained NOC be deemed subject to preapproval by PAAB? The live events would be sponsored by the pharma company whose drug has just obtained NOC. The purpose would be to inform prescribers of the approved indications and appropriate clinical usage. The program would not be accredited.

    This would be a promotional meeting and the meeting itself is not subject to PAAB review. However, if the pharma company sponsor provides slides to the speakers or materials to the meeting health professional attendees, they would be an Advertising/Promotional system (APS) subject to PAAB review. Prescribing information (could be a product monograph or a package insert) should be available at the meeting.

  282. I understand that if a company decides to hand out the full PM instead of a PI, it is fine. My question is: Would a verbatim copy of part 1 and 3 of the PM (Health Professional Info and Consumer Info) also meet that requirement (i.e. the full PM but omitting Part 2).

    Yes

  283. We are producing a directory of canadian clinics that offer a specific test. There will be an introduction outlining why the test is important, how it is done etc. The booklet will be sponsored by a drug company (corporate logos will be on the cover) but there is nothing in it that mentions their or any other company's drug products (and they have no affiliation with the tests, clinics or instruments used). The booklet will be distributed by the sponsors reps as a service. Healthcare providers will offer independent review of the content. Does this require PAAB review?

    This item as described would not require PAAB review.

  284. Could you give me any clue about the adversting or marketing expenses limit set by the government for a pharmaceutical company in a year?

    We are not aware of any government regulations regarding marketing expense limits in Canada.

  285. Could you please confirm for me whether or not a Dear Doctor letter outlining a Nursing Assessment program needs PAAB approval. The program is being run by a 3rd-party. The letter does not contain any information about product and it outlines the parameters of the program itself (i.e. # of patients needed to be recruited, length of day, etc.) The Dear Doctor letter is being left with the doctor and it is being delivered and signed by the representative.

    This question is too vague for us to answer. We would need more details than this to give proper advice on its status regarding adverting law and the PAAB code. You can always call the PAAB Chief Review Officer Patrick Massad for free verbal advice; the PAAB charges a fee for written opinions including e-mail.

  286. Recently the FDA issued new guidance for the distribution of medical journal articles and medical or scientific reference publications by drugmakers that address off-label uses of approved compounds. Among the new recommendations, the FDA stated that the drug manufacturers will no longer have to submit medical journal articles on unapproved new uses of cleared products to the FDA before distributing the studies to physicians. What influence will this have on HEalth Canada policy and what influence will this have on PAAB's rules around distribution of these types of articles by drugmakers representatives.

    Answer as of January 19, 2009 because it is time-sensitive. The U.S. FDA document is a “Guidance” out for comment and it is not law, so caution in interpreting it is needed. Also, it is very complex and you can see the whole thing at http://www.fda.gov/oc/op/goodreprint.html. There are lots of caveats and requirements to meet. Read the disclaimers carefully. This guidance replaces the FDAMA 401 provision that expired in 2006 (since 2000). The FDA has been wrestling this issue since then. Keep in mind the US government has changed to a Democrat driven government in both the presidency and the House, and Health Care reform is now the number two issue behind the economic situation. There are a number of hawks that are interested in reining in pharmaceutical industry marketing practices and several have spoken against this guidance. A new FDA Commissioner will be selected soon by the new House and we will see what will be the new direction. Keep in mind Eli Lilly just got hit with a 1.4 billion dollar settlement for alleged criminal action regarding off-label promotion during the period 1999 to 2003. There are a number of other recent off-label cases that the Department of Justice and Office of the Inspector General (not the FDA) have acted on. I have recently asked Health Canada about any action in Canada to move in this direction and the answer is “no”. Remember that advertising laws in Canada are not the same as laws in the USA.

  287. Once PAAB approves a patient information brochure, does it ever expire? In other words, can we reprint a brochure that was previously PAAB approved and distributed several years ago? Also, what if the product has a change in ownership - if the brochure was previously approved by the seller of the product, can the buyer of the product use the same content without re-submitting for a new approval? The only change would be the addition of the new owners trademarks and the removal of the previous owners tradaemarks.

    Please see Code section 8.4 (a) which allows a maximum period of 12 months for PAAB clearance acceptance of all Advertising/promotion Systems (APS) that do not include market share or price claims. If the APS is to be used longer than 12 months then the sponsor should submit a renewal submission request for pre-clearance review. Information about the drug or marketplace conditions may change over time.

  288. We are currently preparing our submission for a new product to Health Canada. In the meantime, the company is preparing it's financial report for the investors and they would like to include a section on the disease, it's implication on patients and a section on the molecule itself with results of it's phase III trials. Are there any restrictions, and/or do we have to submit the report to PAAB?

    There are restrictions. From a regulatory perspective, you could do something as a “Press Release” following the category requirements in the Health Canada guideline “The Distinction Between Advertising and Other Activities” available on the HC web-site or found through a link to HC in the “Resources” section of the PAAB web-site.. If done properly and it is not promotional in nature, it would not be considered “advertising” subject to PAAB review. However, please note that if the activity does not meet all of the requirements for the advertising exemption, it would be considered “advertising” and subject to the provisions in the PAAB Code of Advertising Acceptance and possibly be in violation of the Food & Drugs Act.

  289. Mon client doit faire une pièce visuelle descriptive de son produit qui sera remise aux professionnels qui l'utilisent, soit les médecins et les technologues.

    Le produit se nomme SmartVent et c'est un système de délivrance radioaérosol qui permet la production d'imagerie de ventilation pulmonaire. Je ne suis pas certaine si cette publicité doit être envoyée à PAAB pour approbation car c'est un 'medical device'.

    J'aimerais être certaine des règlements pour ce genre de produit.

    PAAB ne passe pas en revue pas les appareils médicaux approuvés par Santé Canada (11.3).

  290. I recently received a copy of your December newsletter which refers to changes that will be taking place on April 2009. With respect to 2.4.3, would you consider a non-prescription, schedule D vaccine to fall into this category? And what about a Schedule F drug, that is non-prescription in Ontario?

    Schedule D vaccines would not fall into this category because vaccines are not considered to be “non-prescription” health products. They generally require health professional intervention similar to schedule F products. The PAAB recognizes federal health product regulations i.e. Schedule F requires a prescription for sale in Canada. I learned in pharmacy school jurisprudence that when two laws conflict, always defer to the more stringent law to avoid putting yourself in jeopardy. You can also refer to the NAPRA Drug Schedule categories 1 to 4 for guidance as to what is “non-prescription”. When considering "nonprescription" think "self-selection" as a guiding principle.

  291. Could you please provide some clarity around the definition on Formulary Kits as described in "The Distinction Between Advertising and Other Activities". Specifically, is it appropriate for a company's sales representative to distribute formulary kits to formulary committees in a hospital setting?

    Sales representatives can deliver formulary kit information if the information has been requested by the hospital i.e. if the hospital has standard requirements and criteria for formulary listing requests and the company is meeting the request for that information. If the reps are promoting the product with information in the kit that is beyond the requested information, the company should seek PAAB review. If the audience is broader than the hospital requesting the information for formulary listing, then it would be considered to be advertising. See the “Distinction Between Advertising and Other Information” (Health Canada) for the HC policy. The PAAB has received a complaint from a formulary committee that was bombarded with information beyond what they requested.

  292. Further to the question #76, could you distinguish what 'special conditions' refers to?

    Also, can the key clinical trial be used as support for NOCC advertising, even if it does not appear in the PM in its entirety?

    The “special conditions” are stated in the product monograph approved by Health Canada. Hence “Notice of Compliance with Conditions” or “NOC/C”. It is a tentative approval base don preliminary data and thus the expressed caution about the advertising approved by the PAAB. The conditions can vary by product and state which data the company must generate to remove the “conditions” tag.

    As with all claims based on data from a clinical trial that appears in the product monograph (PM), we would want to know if Health Canada (HC) has reviewed and accepted that data as relevant for promotion. It is up to the sponsor to prove that to the PAAB. We have had a few cases that HC had purposely left out data from the PM and the company did not tell us that. When in doubt, the PAAB will ask HC formally, with the advertisers consent. To repeat, the PAAB takes a cautious approach to approving advertising for products with an NOC/C and generally, data claims not in the PM for a product with NOC/C will not be accepted for advertising purposes. See Code s2.4.2 and the guidance on the PAAB web-site.

  293. Can we use American guidelines to complement or supplement Canadian guidelines in promotional pieces? Often guidelines may have slightly different recommendations or one maybe published later than the other.

    You can generally use valid, published American guidelines to add further support to statements from the published Canadian guidelines. In such cases, the spirit should be to show that the consensus sources are in agreement. We also often permit American guidelines when there are no Canadian guidelines for that specific therapeutic area. We do not, however, consider American guidelines when they are inconsistent with the Canadian consensus. Statements taken from guidelines and used in advertising must be based on good evidence and consistent with the Terms of Market Authorization (s3.1). The PAAB encourages companies to distribute the complete published guideline and it should be the most recent available.

  294. Can you please clarify if there are any differences in terms of the PAAB review of an NOC/c product vs a product with full NOC?

    Health Canada has advised the PAAB to be cautious about approving advertising for products approved as Notice of Compliance with Conditions (NOC/C). There are some special conditions. Health Canada has approved the guideline that the PAAB has posted on the PAAB web-site http://www.paab.ca/en/paab_code/supplementary_paab/advertising_disclosure/. You can access that web page for full details.

  295. I am wondering if PAAB rules allow pharmaceutical companies to run a contest for a consumer product of low value on a gated professional website? Eg. run an online ad asking doctor's to submit their own tagline for an ad and win a basket with $50 worth of products in it? If you need more detail, please give me a call.

    It depends on the nature of the pharmaceutical product. Non-prescription and natural health product companies have successfully run contests of this nature in the past. The PAAB recommends that prescription drug manufacturers follow the Rx&D Code of Conduct section 11 with respect to special promotions and giveaways. If the contest is run often, you should consider the “inducement of prescription” factor.

  296. When a new company purchases an existing brand with existing PAAB approved marketing materials, do we need to resubmit those materials if the only changes relate to corporate ownership and the replacement PI?

    You do not have to submit the files for a review unless the twelve month clearance period has expired. The PAAB does appreciate receiving notification that the brand has changed ownership in case we receive complaints about the advertising. Beyond the scope of the PAAB Code, you would have to respect legal requirements of declaring proper ownership on the advertising pieces.

  297. What is the policy and scope of a PAAB review for Canadian-based websites by manufacturers to support their prescription drug products? Is there a required/preferred review cycle - such as one a year? How does PAAB assess information on the website that is outside of the Product Monograph per se (i.e. - information on the disease state, practical tips for patients managing/coping with their disease apart from drug therapy, links to other websites like a medical association's guidelines)?

    Start with knowing that “Advertising” is regulated information. The definition of advertising includes any means to promote the sale or disposal of a drug. Therefore, if the content of the Canadian-based pharma company sponsored web-site is information that promotes the sale or disposal of a drug or drugs, it would be considered “advertising” subject to the scope of the PAAB Code of Advertising Acceptance (see sections 1 Scope and 6.5 Internet). All Advertising/Promotion Systems (APS) are given a 12 month clearance period subject to a renewal review if the sponsor wants to promote with it beyond 12 months. If parts of the web-site content are changed in any way, a review of that new content is required. The PAAB analyzes all content with respect to the context of the drug therapy being promoted in the APS being reviewed. If disease information that is not part of the approved indication is included in an APS that is drug therapy focused, then the piece will be rejected (see code section 3.1 and 7.6). Otherwise the PAAB review does not look at the quality or reference source of information that is not drug related or is not in a context that includes drug therapy i.e. the PAAB does not review the quality or validity of exercise or food that may be included in the APS. The PAAB reviews links to other web-site information for the validity of it being a reference for drug therapy both in quality and regulatory compliance (within product monograph).

  298. In order for a prescription to be filled for product X, the doctor must submit a form which will function as the prescription to a 3rd party distributor. the form also includes the patient's signature which allows the patient to request the 3rd party company to research the patient's insurance coverage for product x on their behalf.

    There are no product claims on the form (no efficacy, no safety, nothing). Only the doctor receives the form (the patient can not get it any other way then when the doctor makes the decision to Rx the drug for the patient).

    The drug is restricted to a very specific indication; therefore the form includes the specific diagnosis code to allow the 3rd party to ensure that the drug is no prescribed off label.

    The form is a strictly administrative document, the pharma company never has access to any of the specific information (no doctor names, no patient names etc...).

    Am I correct in my conclusion that this would not need PAAB review?

    We would require more information in order to provide a complete answer e.g. Who is the third party distributor? Are there any other suppliers for the drug? Who is creating and providing the forms…? Please feel free to contact the PAAB office directly with your question.

  299. As per 6.6d and the exemption of "now on provincial formulary", does this apply to a change in formulary status? As an example "Product Y has a new formulary status". This is of course would not be linked to a therapeutic message but is intended to inform the audience of a change in formulary status. Would such a mention be PAAB exempt?

    The exemption would still apply given that it remains a “formulary announcement” not linked to any therapeutic message. However, the example that is cited would be unclear as a stand alone because the ‘new status’ is not well defined in the message and may cause confusion.

  300. The PAAB codes allows side by side comparison of non-clinical data from 2 or monographs. Would it be acceptable to use a comparative table of non-clinical data (ie. pharmacokinetics) from a review article?

    Extract from 5.10.2: [Information from two or more Product Monographs on products' properties7 and on instructions for use or use limitations8 may be acceptable as side-by-side presentations and in text form.]

    The PAAB Code (s3.1.1) does not regard “review articles” as high level evidence to support a drug specific claim because they reflect an opinion/ summary from an author rather than actual findings of a primary study. This also applies to non-clinical claims.

  301. The CFPC has reviewed and approved a program for Mainpro-M1 credits and is awaiting final accreditation by the College’s provincial chapter. Are materials used within the program (e.g. Slide Kit) exempt from PAAB review in the following cases:
    • Case 1 - Distributed to participants at the accredited event or at a later date?
    • Case 2 - Distributed to non-participants by sales reps?

    Case 1 - Materials would be considered exempt from PAAB review only after the program has received final accreditation (i.e. once you have received approval for the statement “This program has been accredited by The College of Family Physicians of Canada, and the _____ Chapter, for up to ___ Mainpro-M1 credits”), and the distribution is restricted to registrants of the event (at the event or at a later date) (see Code section 6.6a1). You should also consult the Rx&D Code of Conduct.

    Case 2 –If materials are to be distributed after the event to non-participants of the event by a sponsor company, and product or therapeutic claims, comparative data or statements regarding the sponsors products are included, the complete document must be submitted to the PAAB for review (see Code section 6.6a2).

    Relevant PAAB Code sections:

    6.6(a) 1 Materials that are created by the academic organizers of accredited Continuing Education events/activities may be distributed at the event or to the registrants of that meeting at a later date.

    6.6(a) 2 If materials are to be distributed after the event to non-participants of the event by a sponsor company, and product or therapeutic claims, comparative data or statements regarding the sponsors products are included, the complete document must be submitted to the PAAB for review. The respective roles of the authors and the sponsoring pharmaceutical company must be stated clearly on the title page.

  302. What is the Canadian specific definition for "off label" regarding reprints? FDA in it's draft guidance Good Reprint Pratices refer to indications and treatment regimens. PAAB code section 3.2 indicates material "must be consistent" with the indications, dosage regimens, efficacy and safety information information in the Cdn TMA. If the article is not specifically listed in the TMA, does it automatically be become "off label"?

    PAAB regards “off label” as a claim that is not supported by nor consistent with the Canadian Terms of Market Authorization (TMA). A study that is not listed in the TMA is not automatically “off-label”. We would need to look at the content of the study (e.g study population, dosages used, approved indication) in order to determine whether these parameters are in-line with the TMA or “off-label”. ( See PAAB Code section 3.1)

  303. If a product has a universally-accepted trait (such as no dose adjustment, no specific drug interaction), but this is not stated specifically in the TMA, can this claim be stated?

    At times, some things are not specifically stated in the TMA or the TMA is not updated for a period of time. If a trait is universally-accepted, should it not be permitted to make this claim?

    The PAAB principle is: Generally, you cannot support a claim by omission of fact i.e. the absence of mention of a ‘trait’ in the TMA (Terms of Market Authorization) does not mean that it does not occur. It only indicates that it was not addressed and we do not know its outcome. For example, if no death were reported in the TMA, it is not sufficient to support a claim that the drug does not cause death unless there is a specific mention that “No death were reported”. In summary, if a trait was truly “universally-accepted”, it should have no problem getting into the TMA.

  304. Does the exemption section 6.6d apply to new formats as well? As an example, "Company X is pleased to announce the availablity of a new format y for Product Z. For more information please contact...."

    Yes, as long as it is restricted to an “availability” message without further embellishment or additional message.

  305. Is it necessary to include "Product Monograph available on request" on a direct mail or leave-behind that advises doctors of a drug now being covered on provincial formulary for a specific indication? No claims other than "Brand X now covered on Formulary y for z" (will have the exact wording from the provincial formulary). Understand that fair balance copy needs to be included and this will be submitted to PAAB.

    With the understanding that the fair balance copy already appears on the piece (and the piece submitted to PAAB for review), it would not be necessary to include the statement. Please note that prescribing information (PI) would also be required to accompany this piece as per PAAB Code s7.2 & 7.3.

  306. Does exhibit booth panel text generated by head offices outside of Canada require PAAB approval for International conferences and symposia held in Canada?

    Does an entry in an Exhibit Guide for an International conference or symposium generated by head offices outside of Canada summarizing a recent peer reviewed published clinical trial require PAAB approval?

    Health Canada has a policy regarding materials presented at International Conferences and can be found in the document “The Distinction Between Advertising and Other Activities” at http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/actv_promo_vs_info_e.html#International. To your question, based on the policy, the materials emanating from the parent company would not require PAAB review provided that they are only used within the confines of the conference and are prominently identified as not being authorized for sale in Canada.

  307. When Pharma company sites post their PIs, or Rx drug ads on web sites link back to their PIs - does the access to the PI have to be password protected?

    Before answering this question, it is important to understand the differences between a PI (Prescribing Information) and PM (Product Monograph). The PM is the Health Canda approved document, it is considered non-promotional and can be made available on a company’s website in a non-promotional manner. The PI is an abbreviated version of the PM. The PI is used to accompany advertising and must comply with the PAAB Code section 7.3. To address your question, the PI along the Rx drug ad should appear in a restricted site while the PM (not linked to any promotional activity) can appear in its entirety on an unrestricted site.

  308. Is PAAB concerned if we are correcting typos, punctuation and spelling from a Product Monograph as it enters into a formatted monograph or a PI? Some monographs contains such errors yet pass through Health Canada approval. Does PAAB or Health Canada have a concern if these errors are corrected as the product enters promotion?

    As per the PAAB Code section 7.3, the sponsors are responsible for the content of the prescribing information (PI) while the PAAB will review the PI for format requirements i.e. PAAB will not be reviewing the PI text copy word-for-word. So PAAB would not have concerns about correcting typos, punctuations and spelling. However, you may want to verify with the company’s Medical/ Regulatory Department that the intended message has not changed and that federal regulatory requirements are respected.

  309. If an APS makes a usage claim (number of prescriptions or patient-years, for example) for an agent and shows the product logo, but provides no therapeutic claims for the product, does the indication have to be included? Other than an acceptable reference for the usage claim, is there any other balance copy necessary?

    Although there are no therapeutic claims for the product per se, the usage claim based on marketshare data is considered a claim of merit and viewed as promotional. Therefore, for clarity and completeness as per PAAB Code 2.1 & 2.1.2, the APS should state what the product is indicated for. As for the fair balance requirement, we would need to see the APS in proper context (with visual and text) in order to determine what balance copy is necessary. Keep in mind that fair balance requirement is also based on the product monograph.

  310. Can you please provide some clarity on the criteria regarding co-sponsorship with a physician/patient/nurse/pharmacist group(s) that would allow for PAAB exemption? That is, what criteria make one group more or less acceptable from a PAAB perspective?

    To clarify, if a pharma company wishes to sponsor the development of and work with an organization to supply patients with information on a particular disease state/condition in an unbranded piece how does PAAB judge whether this would/would not be exempt from pre-clearance.

    The criteria for PAAB review exemption are clearly stated in section 6.6 of the PAAB Code. For this case, the materials would need to be independently controlled and prepared without company involvement. If the materials are intended to be used by healthcare professionals for patient counseling and distributed by the company, it would be subject to the PAAB review under section 6.4 (as a service vehicle). Please note that while it may be exempt from the PAAB review, the material may still be considered ‘advertising’ under the Food and Drugs Act.

  311. Is Brogan data an acceptable data source to show how long your patients are statying on therapy?

    Without getting into specific data from individual companies, the PAAB Guidelines for the Review of Market Share Claims (see www.paab.ca) clearly state that market share claims must accurately reflect the findings of the source and the appropriate wording must be used. So, if the source shows “retention” data that is collected from prescription refills, it would be considered. However, the data presentation must not imply any clinical significance or benefits and be reflective of current medical practice (PAAB Code s3.2).

  312. For an advertisement stating that sample packages for Product X are available from company Y's pharmaceutical sales representatives, would PAAB preclearance review be required?

    If it is simply a sample availability message (with no additional message or embellishment), it would not require PAAB review, however, the sample holder / kit may be subject to the PAAB review depending on the content on the box. Please note that a simple message of product availability (Product X available from Company Y) would meet the current PAAB Code exemption (s6.6d).

  313. How do you approach companies to support your organization?

    Offering a voluntary advertising preclearance review program on a fee-for-service basis, the PAAB is a not-for-profit association with 11 association voting members and three individual members. The members include three major pharmaceutical industry trade associations, Rx&D, NDMAC and CGPA. The trade associations encourage their member companies to participate in the voluntary PAAB submission review preclearance program. Also, Health Canada, which is responsible under law for enforcing pharmaceutical advertising regulations has delegated the day to day role of guiding responsible, legal advertising to the PAAB. Health Canada recommends that all companies adhere to the PAAB Code of Advertising Acceptance. As part of a monitoring function, the PAAB staff will contact advertisers who are not following the PAAB code and advise them to send their advertising to the PAAB. Health Canada is copied for any necessary enforcement under the Food & Drugs Act.

  314. Can you use a current FDA approved US Prescribing Information as a reference for PK data?

    The PAAB Code section 3.1 clearly states that all claims must be consistent with the Health Canada approved Terms of Market Authorization (TMA) (e.g. product monograph). The US FDA approved PI would not meet that requirement. The TMA does contain a section referring to pharmacokinetics data and PAAB would look at that section for support.

  315. What happens if our Product Monograph changes between the time of getting PAAB approval on the format of the Prescribing Information and printing of the PI? Since PAAB is only approving the format, would it just be a matter of sending you the updated prescribing information for your information and records (assuming the format did not change)? Thanks.

    PAAB Code section 7.3 clearly states that the sponsors are responsible for the content of the prescribing information (PI) while the PAAB will review the PI for format requirements. All initial changes to the new PI format should be submitted and reviewed by PAAB (as of July 1, 2007). Assuming that the format has not changed from the initial PAAB reviewed PI and only the content has changed, resubmission would not be required. However, you should send us the updated version for our records.

  316. Can we create a program that is directed towards patients as the recipients? Is this considered advertising (direct-to-consumer)? Would it require PAAB review? The content within the program would be on-label.

    Patient support programs are widely used in the market place. They are directed to patients only and are not suitable for “direct-to-consumer” audience. Patient support programs are intended to help patients gain a better understanding of the drug therapy that they are being prescribed. The information should be consistent with the patient information section of the product monograph (Section III of the monograph) and presented in a non-promotional manner. Patient directed materials are subject to the PAAB review as per PAAB Code section 6.4.

  317. Are vaccines treated the same way as prescription drugs for advertising purposes? For DTC, can the brand name of a vaccine be mentioned?

    For the purpose of the PAAB Code, advertising for vaccines are treated the same way as for prescription drugs e.g. consistency with the monograph, evidence for comparative claims, data presentation, etc. For Direct-to-consumer (DTC) advertising, the brand name of a vaccine can be mentioned. We would need to look at the entire context to determine whether there are other issues.

  318. What is the PAAB's expectation with regards to the PI for journal ads that were approved and have been in publications prior to July 1st but have also been booked post July 1st for the remainder of the year? (Repeat of existing ads for monthly journals)

    My concern is that we have paid for a specific number of pages within the publication based on the old PI format. The required number of pages will most likely change as we update the PI with the new format.

    Obviously, we will update the PI for any new ads that we are creating and having approved.

    All materials that have been approved and used prior to July 1, 2007 will remain unaffected until the expiry date, however, any new submission for a new journal ad will require the new PI format. You can always contact the PAAB office for queries on specific projects.

  319. There are two rumors circulating that I don't believe. Please comment/advise.

    Come July 1, 2007, will medical journal publishers be expected to lay out Prescribing Information in their journals in alphabetical order by drug name?

    When all ads finally have the "new" format and include page referencing to the PI on them (assuming all publishers are putting a folio on all their pages so every page has a page number) should/can publishers do away with the Ad Index?

    Ad Indexes are like the TOC (Table of Contents)--but for ads in journals.
    Medical Post does not include an Ad Index, but all other journals (I think) do. I know these sound like CAMP issues--pls help with PAAB's opinion as there is not a consistent understanding amongst publishers on these 2 issues.

    The issue of laying out the PI in a particular order is not a PAAB Code requirement and also does not appear to be covered in the CAMP guidelines. We suggest that you seek clarification from the individual publishers who have their own guidelines. Keep in mind that the PAAB Code s7.3.5 only requires that the page number of the PI appear in the ad portion. Regarding the "ad index" issue, it is a matter that should be raised with the individual publishers as it is not considered a PAAB Code issue but more likely an operational issue with the publishers.

  320. To restrict access to patient web site we usually use the DIN as an accepted method of verifying that the visitor is indeed a patient before granting access. But we are currently working on a web site for a drug where the patients never receive the product packaging. Some of them might be able to find the DIN on their drug store receipt but some receipts don't have that information.

    Are there other accepted methods of restricting access to a patient web site in case the DIN is not available?

    Yes there are other methods of restricting web access to specific patients. Alternatively to a DIN password, healthcare professionals (doctors or pharmacists) could provide the individual patient sign-up information to mail in or go to a web-site url to register for access and obtain a password. The onus is on the sponsor to gate access to the product information to ensure that only patients taking the product have access to the site.

  321. Can a product manager or medical manager provide a slide set to a customer upon request if the slide set contains off-label information?

    As per the PAAB Code section 6.6, person-to-person requests (that are unsolicited) are exempt from the PAAB review and the Medical Department (Medical Information) should be handling such requests. If the off-label information was not part of the request, then it should be removed (unless the customer specifically asked about the off-label issue).

  322. I have already submitted a product's website copy for PAAB approval; however I was hoping to receive clarification around the requirements for submitting the website layout to PAAB:

    Is it sufficient to send the design for a few of the different pages within the site, or would you prefer we submit all pages included within the site?

    Should we be submitting the design once the copy has been PAAB-approved, or can we submit simultaneously?

    Does PAAB like to review the actual website before launch?

    If you could provide a few details around website layout submission, it would be greatly appreciated. I've referred to explanatory note 6.5.11 for guidance.

    Ideally we would like to review the entire website as it is intended to be presented. So, yes, the layout/ design should be submitted in conjunction with the copy deck in order for the reviewer to assess the material in full context. However, we recognize that this may not always be feasible and would agree to review the copy deck first and the final layout at a later stage following copy approval. Finally, we would prefer receiving the entire layout /design rather than a few pages at a time.

  323. If we offer samples to physicians, by a 3rd party company, do we need to get PAAB approval of the offer/promotion if it only contains an graphic/image of the brand name, logo, and quantity of samples offered.

    There will be no claims made...only this minimal information. Does a PI need to accompany the offer?

    A simple sample request form would not require PAAB review provided that there are no additional messages or embellishment such as taglines or claims of merit. However, if it is part of a promotional piece (e.g. detail aid, journal ad), it would be subject to the PAAB review.

  324. As a follow up to Question 45, if the off-label content of a peer reviewed journal article is not the focus and will not be discussed by the rep, can a disclaimer be added indicating that the product should not be used off-label, any off-label content is not applicable in Canada and to refer to appropriate product monographs?

    Yes, that would be an option if you meet all of the Health Canada guideline requirements. You can provide it in a complete manner, you should not promote the contents.

    This is verbatim from the Health Canada Policy:

    "Dissemination of full, unedited reference texts (textbooks, chapters of textbooks), government publications or reprints of published, peer-reviewed articles from medical or scientific journals, that are identified as being provided courtesy of a pharmaceutical manufacturer, may be a nonpromotional activity provided that:

    • no link between the text and promotion of a drug is established by the manufacturer.

    Such material may be considered to be advertising where the aforementioned condition is not met or where other factors indicate that the primary purpose is to promote the sale of a drug, for example:

    • the material is accompanied by any form of additional information (e.g., printed, word of mouth) designed by or on behalf of the manufacturer for the purpose of promoting a drug (e.g., detail aid),
    • the material was written or edited by an employee or agent of the pharmaceutical manufacturer,
    • a summary or interpretation of the text prepared by the pharmaceutical manufacturer or his agent accompanies the material,
    • reference is made to the availability of an unauthorized drug through the Special Access Programme."
  325. Can peer reviewed journal article reprints be distributed by sales reps or sent by direct mail if they contain off-label discussion of a drug?

    What about textbooks purchased from a publisher (no development involvement by the pharma company)?

    No. While published peer-reviewed journals do not require PAAB preclearance review they must meet "advertising" requirements if the purpose of the unsolicited distribution is to promote the sale of a healthcare product. To decide that we would look at the content of the reprint. If there is emphasis on a product of the sponsor of the distribution in the reprint, distributed either by rep or mail, then it would most likely be seen as advertising. Off-label promotion is in contravention of the Food and Drugs Act so all statements in the reprint should also be seen in the approved product monograph.

    Independently published textbooks with no emphasis on the sponsor's products are not considered to be advertising when they are distributed in their whole with no promotional elements attached. If the book was mostly about the sponsor's healthcare product, it would be considered advertising and off-label statements would not be allowed.

  326. I support a number of small products which are supported by one sales force. In order to simplify detailing efforts, I would like to produce one detail aid for all the products, with a few pages dedicated to each one.

    When it comes to the prescribing summaries, should these be placed together at the end of the detail aid, or with the pages related to that product?

    Either option is fine. Another option would be to have loose-leaf prescribing information (PI) for each product that the representatives could distribute on request. The reps could offer the PI at the time of promotion of the detail aid. Code s7.3 says the PI "should form an integral part of the presentation or be attached to it". So it can be loose and accompany the piece. The doctor may choose only those PIs that he or she may want. We can save some trees.


  327. I am interested in producing an empty folder with my product name and logo on the front, PI on the back. The folder is to be provided to representatives with no contents. Reps would have a choice of any currently valid and PAAB approved contents to place inside, the whole package to be left with the physician.

    When I submit the folder to the PAAB for review, is it sufficient to explain that the only possible contents will be valid and PAAB approved APS, or is it necessary that I submit with all the possible combinations and permutations of contents?

    Am I permitted to submit for review a reprint which I would also like to be available for inclusion?

    Declaring that you will only include valid PAAB approved material should be sufficient. Keep in mind that you may be restricted from including Editorial (s7.8) material in a product branded folder even though it was PAAB approved. The PAAB does not require submission of independently published reprints; however if you sent it to us we would tell you if it was acceptable advertising in relation to other requirements of the PAAB code.


  328. Please outline the rules for the following: If a client wishes to use a product reminder ad without any accompanying prescribing information (assuming that there are no claims and the product is a minimum 2 years old with no reports of new adverse reactions)

    The rules are clearly stated in s7.6 Reminder Advertising/Promotion Systems of the PAAB Code of Advertising Acceptance. The code is available on the PAAB web-site www.paab.ca.


  329. Just looking for some clarification on PAAB review of health education material (CME accredited, third party accrediated workshops, etc.). When sent in for review, will PAAB be providing an opinion only, or would it be acceptance of the material under review? Additionally, will existing printed material need to be sent to PAAB for review, or is just newly created material that has this requirement of review? Thanks in advance for the help in answering.

    PAAB reviews advertising. See section 1 in the code for scope and s11.1 for the definition of advertising. If the material is sponsored by a manufacturer or distributor of a product and the material appears to promote the sale of the product, it is "advertising". See s6.6a of the code for exemptions of truly independently produced educational material. So, it doesn't matter what you call the material, if it fits the definition of "advertising" the PAAB will review it to approval if that is possible. The PAAB reviews material intended for advertising. I am not sure what the last part of the question means.


  330. At a recent medical conference there was a company display that promoted a disease specific message. There was no product mention and the posters did not go to PAAB, although the imformation clearly introduces a specific message. As per question and answer #39, this would seem to be within guidelines, assuming there was no other promotional material at the booth. The complicating factor is that this company does not have an approved product for the disease state being presented. There is a great deal of discussion and "noise" surrounding their product and when it will be available but, to date, it has not receieved NoC. Is this within guidelines? It appears to be promotion for a product currently undergoing review?

    It is difficult to answer this question precisely without all of the facts to see and know. What was the "specific message"? The question I ask is "Are they advertising a particular product?" Advertising is regulated information. Companies can present disease information as long as they don't state or imply that it is linked to a particular product they make if the product status is pre-NOC. If it is pre-NOC, I would not expect to see specific product material to link to. Keep in mind PAAB code section 7.8 does require company-generated editorial ads to be pre-cleared if they fit the requirements such as mechanism of action or discussion of current healthcare product therapy. Company-generated "discussion and noise" about a particular product pre-NOC is considered to be off-label i.e. illegal. The smoke and mirrors approach to get around the law is considered to be unethical. Over 400 pharma industry personnel and physicians in the U.S. have been indicted for behaving that way. I am not aware of that happening in Canada because of the checks and balances we have in our promotional system e.g. PAAB. We do have occasional cases such as your example and we discourage widespread behaviour such as that through our complaint system. We will get Health Canada involved if the PAAB proves to be ineffective in stopping specific pre-NOC cases. remember, if "it appears to be promotion for a product currently undergoing review", it probably is promotion and illegal.


  331. Are we required to send material on disease awareness to the PAAB, even if there is no product metnion? Is there a distinction if it is leave behind vs. non-leave behind (eg, a detail piece on hypertension and the MOA of how a therapetuic class works)?

    PAAB Code section covers editorial pieces generated by a pharmaceutical company. That means the piece would not exist without the pharma company's financial involvement. The PAAB reviews editorial pieces where healthcare products are mentioned. See Code s7.8. Therefore, if you are talking about mechanism of action of how a therapeutic class works, and the piece is sponsored by a healthcare product manufacturer, I would say that would require PAAB review because it would be difficult not to allude to the sponsor's product and it would appear to promote the sale of that product indirectly. See Code s11.1 for a definition of "advertising" applicable to the PAAB code. Section 1 describes the scope of the PAAB Code. Editorial pieces about disease awareness that do not mention healthcare products directly or indirectly through class would be exempt from PAAB review. Keep in mind bundling that type of piece with product advertising would make the whole thing "advertising" subject to the regulations. There is no distinction between a leave behind and non leave behind with respect to the requirements of the PAAB Code of Advertising Acceptance.


  332. Regarding Representative distribution of CME Accredited Materials:

    Can a program supporter have their representatives distribute or base discussions on CME accredited materials ?

    If I look at the these points it is unclear to me if indeed there can be representative involvement if so , at what level? :

    6.6(a) 1 Materials that are created by the academic organizers of accredited Continuing Education events/activities may be distributed at the event or to the registrants of that meeting at a later date.

    6.6(a) 2 If materials are to be distributed after the event to non-participants of the event by a sponsor company, and product or therapeutic claims, comparative data or statements regarding the sponsors products are included, the complete document must be submitted to the PAAB for review. The respective roles of the authors and the sponsoring pharmaceutical company must be stated clearly on the title page.

    In my view, sales representatives sell products so when they use "CME accredited materials" to promote the sale of a product I.e. "base discussions", those materials may become "advertising" under the Food and Drugs Act and the PAAB Code of Advertising Acceptance. One can make an argument that sales reps should be able to deliver material requested by physicians. However, the company has to demonstrate control mechanisms to prevent the reps from detailing. They can detail "CME" materials but then those materials become "advertising" subject to all the advertising rules, not the CME exemption. A good principle to remember is that just because you call something by a chosen name it doesn't mean it becomes that. CME is a non-promotional activity so keep your reps away from CME activity and your company will not be perceived as breaking the rules.

    Remember these are "Exemptions from PAAB review" and in some circumstances the item can still be perceived as advertising subject to other provisions of the Code and federal law. Be sure to read all of 6.6(a) . The section about the "Distinction Between Advertising and Other Activities" and see the seven questions to ask to determine if something is advertising. Focus on the left side of the code and you won't go wrong. Ask yourself the question "What is my intent in the distribution of this material". Read the whole section.


    remember the content matters. If it does not "focused on or provide emphasis on, the sponsor's product(s)..." it would usually not be considered "advertising" and would be exempt from PAAB review and the code application.


    We interpret this section as saying that you have admitted that what you are doing is "advertising" and because your company was responsible for generating the piece through sponsorship it should come to PAAB for review. Just because you say it isn't advertising doesn't make it exempt. Independent production and no focus on the sponsor's drug are key elements regarding the interpretation of whether or not something is advertising.

    When in doubt about a particular project, you can ask the PAAB for an opinion. There is no charge for verbal opinions and we charge a fee for written opinions. Give us a call at 905-509-2275.


  333. It is our understanding that sampling live medication (traditional clinical evaluation packages) to physicians at a Medical Conference contravenes Rx&D Guidelines and the PAAB?

    However, a new form of alternative sampling which uses a paper based vehicle (SmartSample technology) for physicians involves the pharmacist in dispensation of the drug sample (live product) to the patient. Therefore, the SmartSample is simply a vehicle for physicians to hand to appropriate patients during their practice.

    We want to provide these SmartSamples to physicians at medical conferences because some physicians may not see representatives in their practice, but could still benefit from the sample opportunity. We believe that this vehicle is similar to information pieces and may or may not be PAAB'ed depending on whether product claims appear on the SmartSample itself.

    Is it allowable to use these at conferences with physicians? Do we need to gain PAAB approval for their use?

    The act of Sampling as a marketing practice is directly covered by the Food & Drugs Act (Health Canada) and the Rx&D Code of Conduct. Whether or not you sample is not a PAAB Code issue. The actual sample package is a labeling issue subject to federal law. If you include materials related to the promotion of a particular product, that would be a PAAB Code issue. This is similar to the age old practice of creating a sample holder for samples. PAAB reviews the sample holder but not the sample packaging itself. PAAB would review the Smart Sample product promotional material accompanying the Smart Sample package. We have done that for some companies already. You can call a PAAB reviewer for an opinion if you have a specific example in mind.


  334. In your answer to question 34, you state "If the information is created independently of the company it is usually not advertising."

    I can think of clear examples of "text or reference books" that are produced by an independent publisher, but which deal almost exclusively with a single pharmaceutical product. If such items are paid for and distributed by company representatives, even though produced independently, are they advertising?

    I said "usually" for a reason and you found an exception. Refer to the Health Canada document "the Distinction between Advertising and other Activities". If the book is primarily about one drug, distribution by sales reps would probably be viewed as a promotional activity because that is what sales reps are paid for. Independently published text books are not required to be reviewed by the PAAB. The content of the book would have to be examined to see if there is a violation of the PAAB Code. This case is similar to distributing clinical reprints that were independently published.


  335. At a recent visit to my physician, I ran across a display of disease information brochures (eg, diabetes) branded with a product name in the waiting room. I was always under the impression that this would be considered DTC and that we are not allowed to provide branded disease information to the general public. Can you clarify?

    Your example would be considered "advertising" because it links the drug name and the therapeutic use. This would be a violation of the Food and Drugs Act section c01.044. PAAB provides an advisory service to avoid this type of violation.


  336. Heatlh Canada has issued a policy entitled "Distinction Between Advertising and Other Activities" which states that " No one factor in itself will determine whether or not a particular message is advertising. Each message must be evaluated on its own merit and other factors may apply."

    An earlier response in this forum suggested that if it was a single sponsored publication, it was quite likely to be advertising if it dealt with therapeutics (you used the term "rarely" to describe the incidence with which you have seen non-promotional single-sponsored 3rd Party pieces.)

    Here's my question - if it is a single sponsored publication and mentions both the sponsor's and the competitor's products, giving them more coverage than "name, price, quantity", but not creating an impression in the reader's mind of bias, is it advertising?  It seems obvious that one person's perception of information distribution "...serves to promote the sale of that product either directly or indirectly" (s11.1) may differ from anothers.  And how does pharma or their agents know when when the line from "other activity" to "advertising", based on Health Canada's policy, has been crossed, short of a violation or submitting everything for a review?

    Please see section 11.1 in the PAAB Code. It gives the PAAB working definition of advertising. That is what we use for the purpose of the PAAB Code. The health Canada "Distinction ..." Document explains how Health Canada interprets what is "advertising". A company stays in business by selling its products. It invests money into communications about its products to enhance their sale. That is advertising. If the information is created independently of the company it is usually not advertising.

    Companies want an ROI on money invested into communications projects. I have not seen many examples of communications created by pharma companies about their products that were not intended to sell their products.


  337. Once a journal ad is PAAB approved, are we required to resubmit the approved JA for PAAB approval if the only change that will be made is to the dimension of the JA (eg, from standard to tabloid size)?

    You don't have to resubmit for approval if it is just a size change. We do like you to send us a note informing us of the new format for our record. If you change wording or move things around it should be resubmitted for approval. If you shrink the size, remember the minimum type size requirements.


  338. To show "risk of event data" for concomitant risk factors does the risk factor have to be specifically worded within the indication or can be elsewhere in the monograph? (ie what does consistent with the indication mean?) As an example, smokers are 30% of the persons within the pivotal trials, the monograph lists no contraindications to smokers and the monograph mentions that smokers were in the trials, can we establish (based on published data) that smokers with high cholesterol are at increased risk of events? ( the events would be consistent with what the cholesterol agent is indicating for).

    The subset population should be mentioned in the indication and dosing sections of the PM. Just a mention in the clinical trial section would not allow emphasis on the claim. We could accept a verbatim statement in the same context as how the statement appears in the PM without emphasis.


  339. Where can I find good samples of detail aid online?

    Advertising of prescription drugs beyond name price and quantity to the general public is prohibited by law in Canada. Therefore, it would be difficult to find such material on an open web-site. Individual companies have password protected sites for promotion to health professionals. You would need a health professional to help you gain access or company permission on an exceptional basis. Also, the Ontario Medical Asssociation is launching their OMD web portal and pharma companies can put promotional detail aids on that site with access being restricted to registered physician members. You can see promotional material on U.S. based pharmaceutical company sites. We cannot speak to the quality of that material because they would not have been reviewed by the PAAB.


  340. Can risk data be presented for patients with concomitant risk factors. ie, the product is a statin that is indicated to reduce cholesterol and also CV events in patients with high cholesterol. The registration trial obviously included patients with high cholesterol and other risk factors. Can risk data be presented on patients with hypercholesterolemia and a risk factor within the registration trial?

    Risk data for patients with concomitant risk factors can be presented in advertising if those data are consistent with what has been approved in the product monograph (PAAB Code s3.1). In the example mentioned in the question, the PAAB would accept claims related to the cardiovascular events that are stated in the product monograph. If the risk factor in the registration file is specifically stated in the product monograph it can be presented in advertising. Just because a study is cited in the bibliography section of the product monograph does not mean the PAAB would accept all data claims from that study. Get your regulatory folks to include all relevant data claims in the product monograph text, not just a listing in the bibliography.


  341. If a non-profit organization is producing patient support materials funded by an unrestricted grant from a pharmaceutical company (who is completely hands off and has no involvement other than funding), are these materials PAAB-exempt?

    The materials will be reviewed by a panel of health care practitioners to ensure validity and relevance of the information.

    Yes, it would be PAAB review exempt due to the independent nature of the production and assuming the content is balanced and objective. If the content appears to be promoting the sale of the sponsor's product it would be deemed "advertising" subject to PAAB review and the PAAB code. See section 11 of the PAAB code regarding the definition of advertising.


  342. I would like to run a print DTC advertizing campaign. The content will be limited to the brand name and a sentence along the line of 'ask your doctor'. No claims will be made. The media used is not targeting any specific audience.

    I would like to know:

    • if the text has to be submitted
    • if the text on the actual support has to be submitted
    • which articles of the code I should refer to

    DTCRx ads are not subject to mandatory review within the requirements of the PAAB Code of Advertising Acceptance. If the sponsor requests it, PAAB will give an opinion on DTCRx ads based on the Health Canada policy document "The Distinction Between Advertising and Other Activities". The opinion service is endorsed by Health Canada and Rx&D. If you choose to send a DTCRx project for PAAB opinion we would require seeing the layout, graphics and words to be used.


  343. We recently made a complaint to PAAB about a detail aid which our competitor is using, as the detail aid is not PAAB-approved. We have heard nothing in response, and are wondering what we can expect from the process.

    Call PAAB. The commissioner answers all correspondence. Perhaps it didn't make it into the PAAB office. A phone call can solve your problem.


  344. In section 6.1 of the PAAB Code is the following: Journal advertisements are designed to promote an advertiser's products to health professionals via the media of single [11.9] or multi-sponsored publications.

    Section 11.9 clarifies that: For purposes of this Code, Private/Single Sponsor Journals, newsletters and other publications are defined as any commissioned communication prepared or controlled by the manufacturer or its agent. When can a publication be considered a journal? I ask because I am interested in supporting a single-sponsor publication by placement of an ad, but am uncertain whether this publication is actually a journal or a service-oriented vehicle. Can I place a journal ad in a service-oriented vehicle?

    A medical journal is independently published on a regular, periodic basis. The nature of the content is approved by an advisory board e.g. cardiology information, and the editor is responsible for ensuring the integrity of the information that is provided and how it is presented. In single-sponsor journals, the sponsor usually has a vested interest in the nature of the content knowing that information about their products will appear. We have seen examples of independently produced single-sponsor journals, rarely. Usually there is a promotional element to them and that would require PAAB review. Placing advertising in a single-sponsored publication usually makes the whole thing advertising, based on a Health Canada policy on combining branded and non-branded information. You can place a previously PAAB-approved journal ad in a service-oriented vehicle during the 12 month clearance period, and we ask you to inform the PAAB that you are doing that. It does not require a new re view if the ad has not been altered in any way. The PAAB may ask to see the whole thing for an opinion, because context of the advertisement is important. Similarly you can convert a journal ad into a detail aid during the clearance period, let us know. Any newly created ads or modifications of existing ads destined for a service-oriented vehicle would require PAAB review. You can call the PAAB for an opinion on the review requirement of a single-sponsor publication if you are intending to do one.


  345. I am trying to understand how Sections 6 and 7 of the PAAB code fit together. Can these be viewed as "alternate" classification schemes for APS? For example, can you have a Service-oriented Vehicle (section 6.4) that is a Full-disclosure APS (section 7.4)? A Service-oriented Vehicle that is an Editorial/Advertising APS? etc..

    It almost appears that sections 7.7 and 7.8 belong in Section 6, since they appear to define additional categories of APS, and are relatively silent on disclosure information. And how do Section 6.4 and Section 7.8 connect with each other?

    Section 6 is titled "Advertising/Promotion Systems (APS) Categories". That covers the different types of media used to promote healthcare products and it is fairly comprehensive of the current marketplace. See section 1 "Scope".We classify the type of advertising activity based on this section. Section 7 is titled "Disclosure/Prescribing Information Requirements". That covers the placement and format requirements for the additional prescribing information. They are separate entities and are not considered "alternate" classification schemes for APS. They are complementary in purpose. The PAAB uses both sections of the code to classify individual APS. If you see a PAAB file number on submission review correspondence you will see a letter code that combines the two e.g. DAF which would be a detail aid (s6.3) that requires Full Disclosure (s7.4). It is possible to have a Service-oriented Vehicle (section 6.4) that is a Full-disclosure APS (section 7.4) anda Service-oriented Vehicle that is an Editorial/Advertising APS etc..

    Sections 7.7 and 7.8 does not require additional prescribing information if the advertising meets the requirements in those sections. These types of ads can appear in any of the media stated in section 6 and, thus, are complementary. One way sections 6.4 and 7.8 could be connected is if you were providing patient information of an editorial nature controlled by the sponsor to healthcare professionals for distribution to patients. This would include telling HCPs to advise patients of a website. That would require PAAB review.


  346. The PAAB Code defines single sponsor publications in section 11.9, and notes in section 6.1 that branded content inserted into same are Journal Advertisement APS.  Is the balance of the content of a single-sponsor publication exempt from PAAB review?  Or is it considered service-oriented or detail aid APS?

    What if the ad is placed in a publication for the purpose of sponsorship of an ongoing title offered by an Independent Publisher?

    First, you should check the definition of "advertising" in PAAB CODE s11.1. Also see code s7.8 for Editorial Advertising. Most single sponsored journals are considered to be advertising unless the independence of the publisher can be well defined. That is usually difficult to do because the publisher is usually acting as an agent for the company. There are some single-sponsored journals that do have independent editorial control. According to Health Canada policy about combining branded ads with nonbranded information, if you place a product ad in a single sponsored journal it can make the whole vehicle advertising and thus, it would be subject to PAAB review if the information is related to product use. If you have an independently produced single-sponsor journal, the ad would be considered under code s6.4 service oriented vehicles. The PAAB provides an advisory opinion on the PAAB Code advertising status of specific promotional tools. Phone call advice is free of charge and written opinions are charged a fee.


  347. How do you know when to submit an APS as a Detail Aid APS (s. 6.3) or a Service-Oriented Vehicle (s. 6.4)?  Are there characteristic hallmarks that tell you which way one should go?

    Detail aids (s6.3) are product advertising tools that are used by company sales representatives. They are used to directly promote a product's risks and benefits to health professionals. They contain only promotional messages. Service oriented vehicles (6.4) are promotional tools that have a component that may be useful to a health professional even if the advertising component was removed. Examples are anatomical charts or drawings, patient information, patient aids, disease information etc.


  348. A pharma company has commissioned a third-party to create a patient support package. This package is given free to the patient from the doctor when they begin treatment. The package contains product monograph and consumer products to help with the drug's side-effect management. Can the package also contain products that do not deal with the side effect management, but relate to the product's target age group ie: a purse or wallet, a backpack, free music downloads etc? And is there a limit on the value allowed for the patient support package?

    PAAB Code s6.4 applies to patient information. PAAB Code s2.8 states "Promotional items offered in advertisements must be related directly to the product or its use(s), or be of practical value to the health professional. Such gifts must withstand professional and public scrutiny. Items intended for distribution to patients via a health professional must be useful as aids to patients' understanding of, or adaptation to, their condition(s) or for encouraging compliance with recommended therapy." Therefore, this question is not relevant to s2.8 because the giveaways are not being offered in an ad. The Rx&D Code of Conduct applies to service-oriented items such as the purse etc in this example and to "special promotions". If the "consumer products" were nonprescription drugs, federal sample laws would apply.


  349. The PAAB Code presents 5 categories of APS in Section 6, and elaborates on prescribing information requirements that must be associated with each type. Is it correct to say that all other requirements of the code still apply, regardless of the APS category?

    All requirements of the code apply regardless of the APS category. See section 1 for the Scope of the PAAB Code. PAAB code section 6 states "Prescribing information (when required) should form an integral part of the presentation or be attached to it." PAAB Code section 7 states the actual PI requirements that correspond with the type of advertising.


  350. If there is an English and a French same product ad in the same medical journal, does the P.I. have to be repeated or will just 1 P.I. suffice?

    To provide complete information for the reader as required by the PAAB Code s2.1 and s7, you should provide the Prescribing Information (PI) in both languages to accompany the ad that is pesented in both languages.

  351. Do Contrast Media and Nuclear Medicine products fall under the PAAB code?

    Yes. The PAAB code applies to advertising of healthcare products including drugs, biologicals and natural health products to health care professionals.


  352. When new data is published outside of the Product Monograph, can this data be used for promotional pieces?
    Is there a way to incorporate this data without updating the product monograph?

    Section 3.1 of the PAAB Code of Advertising Acceptance states "Advertising / Promotion systems (APS) must be consistent with, and within the limitations of the Health Canada Terms of Market Authorization" (that includes the product monograph).

    Section 3.2 states that studies used as references in promotional material should be "within the limitations of the Health Canada accepted product monograph ...".

    Therefore, if the data are used to support a claim that is not within the limitations of the product monograph, the advertising will not be accepted by the PAAB. As an example: if a product was approved for an indication of reducing blood pressure at x dose and you produced a study that was not in the product monograph but included an evaluation of the product in reducing blood pressure at x dose, the PAAB would accept the advertising. Conversely, if the new study showed a rate of efficacy or safety of 80% and the data in the product monograph showed a different number e.g. 60%, the PAAB would not likely accept the 80% claim. You can call the PAAB office and ask a reviewer for a verbal opinion if you have specific questions about whether specific data claims would be acceptable within the limitations of the current product monograph.

  353. If a reprint carrier is being produced, can the content be based on the paper even if some of the points to be made are not part of the product monograph? For example, if data pertaining to subgroup and multivariate analyses were not included in the product monograph but are discussed in the article, can they, i.e., subgroup and multivariate analysis, be part of the text highlighted on the reprint carrier?

    According to section 3.1 of the PAAB Code claims in advertising, including reprint carriers, should be consistent with the Health Canada approved product monograph and labeling. The PAAB would not approve distribution of a clinical reprint that focuses on off label claims. It may be acceptable to distribute the reprint as a whole if the off label claims are not the primary focus of the study. That is variable and subject to review for a definitive statement on specific cases. However, the off label claims should not be highlighted on the reprint carrier. The PAAB has had intervention by Health Canada regarding subgroup analysis claims that have appeared in advertising and did not appear in the product monograph. We would suggest submitting the data to Health Canada as part of an SNDS.

  354. Can a pharmaceutical company distribute a third party piece (a textbook) via their representatives? It is a textbook that they are providing sponsorship for only and thus is exempt from PAAB rules (Section 6.6a)).

    Does this book require a reference section with the product monograph in it as the product is discussed within the content of the textbook?

    Yes, pharmaceutical companies can distribute textbooks via their representatives. With respect to how it fits into the PAAB Code s6.6.a, it depends on what "sponsorship" means. If the book was published independently and not commissioned by the pharma company, it would be considered to be third party. According to Health Canada guidelines in the "Distinction Between Advertising and Other Activities" independently published textbooks would not be considered advertising when distributed by pharma companies. That means the company had no involvement in the production of the textbook. If the textbook content was balanced and objective and did not appear to promote the sale of a product, it would not be considered 'advertising'. If the textbook content focused mainly on the sponsor's products, it could be considered 'advertising' when distributed. If the pharma company was involved in the production or selection of the writers and it mentioned healthcare products, it could be consider ed 'editorial advertising' with respect to section 7.8 of the PAAB Code of Advertising Acceptance.

    It is a good idea to show the references for any scientific publication. Whether the book is not 'advertising' or if it is 'editorial advertising' subject to PAAB review, the product monographs of the products mentioned in it does not have to be shown as part of it. If the book was focused on the sponsor's products it could be considered to be 'product advertising' and therefore the prescribing information requirements of section 7 in the PAAB Code would apply.


  355. Are there specific APS guidelines for corporate booth panels? Is it possible to create a panel/poster that just lists the product and its indication and not provide full product balance (i.e. adverse events and contraindications)? Full product balance/PI would be available at the same corporate booth.

    There are no specific PAAB guidelines for corporate booth panels. Health Canada has a guideline for what is advertising in Exhibit Booths in their policy document "The Distinction Between Advertising and Other Activities".Advertising in corporate booth panels is subject to PAAB review. In this case, you can do an institutional ad and list the products and therapeutic class with respect to PAAB Code section 7.7 that reads:

    7.7 Institutional Advertising/Promotion Systems (APS)

    These are designed to create and maintain a favorable image of a company, its products and its services. See exemption [6.6 (e)].

    These systems may be used at any time at the discretion of the advertiser but must be submitted for PAAB review and acceptance prior to publication. They must not contain therapeutic or other claims of product merit or status. They may contain:

    (a) A general statement about the pharmaceutical company, its products and its service(s) and policies.

    (b) A partial or complete list or illustration of products manufactured and/or distributed by the company, along with their respective therapeutic [11.4] or pharmacologic [11.5] classifications.

  356. Could a brand name be placed on a plastic portfolio that would contain a reprint carrier.

    The PAAB reviews the APS as a whole and we advise that they check with Rx&D regarding the plastic portfolio since they have ruled against similar vehicles.

  357. Company A has a new drug that they anticipate will have a relatively small market potential. They want to test new patient brochures, but don't have a market research budget. The Sales Manager has proposed getiting the reps to ask their key physicians what they think of the new materials. Is this practice contrary tp PAAB or Rx&D guidelines?

    The preclearance review requirement for Patient Brochures is in section 6.4 of the PAAB Code of Advertising Acceptance. Regardless of the size of the company, sales representatives have the explicit function of selling the company's products. Market research is a functional area that helps companies do marketing planning and should not be a disguise for promotion. Ideally, Market Research involving focus group testing should be conducted by personnel other than sales representatives. Also, the content of the brochures and the number of doctors that are asked to test the brochure are factors in determining if the company is promoting legally or testing. The Rx&D Code of Conduct includes Market Research activities and should be consulted.

  358. ACME Pharma ha 20% of the share in Rx's in its class and has been gained about 5% share over the previous year.

    NEWGUY Pharma has a 2% share, up from 1% the previous year. Can NEWGUY claim "fastest-growing" product within its class by virtue of a 100% growth? Even though ACME experienced only a 20%, twenty percent of a million is a lot more 100% of 20,000.

    How would PAAB rule NEWGUY's claim of "fastest-growing" or "largest annual growth"?

    The PAAB would reject the claims. For "Fastest growing" claims, there must be a minimum growth of at least 5% (absolute) over all other products in the same category during each of the last 6 consecutive and the product must have been on the market for at least one year. See the "Supplementary PAAB Guideline for the Review of Market Share Claims in Advertising".


  359. Further to the question about the authority of PAAB on non-RX&D companies regarding claims in promotional materials, is it a requirement for non-RX&D companies to submit all promotional pieces to PAAB? As well, can RX&D companies send in non-RX&D company promotional materials to PAAB as complaints? Lastly, if these complaints to do to Health Canada, what process is in place to make a ruling on the material in question?

    The PAAB Code of Advertising Acceptance applies to all sponsors of healthcare product advertising. PAAB Code section 1 describes the scope. "All proposed copy and illustrations for APS intended for distribution to health professionals must be submitted for PAAB review and clearance prior to use." The PAAB advisory review service is recognized and endorsed by Health Canada. The PAAB will review complaints about advertising for healthcare products directed to health professionals. See PAAB Code section 9 for details about the complaint process. Health Canada will transfer "trade dispute" complaints to the PAAB. Issues involving public safety or Direct-to-Consumer advertising of prescription drugs will be handled by Health Canada. See the Health Canada policy document "PAAB and Therapeutic Products Directorate Roles and Consultation Related to Advertising Review" at www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/role_paab-ccpp_e.html. For companies who are non-compliant with the PAAB, we will send a complaint to Health Canada in accordance with their policy. After going through that process several companies have pledged to to be faithful in sending their material to the PAAB.

  360. What does "well-controlled and/or well-designed" in s. 3.1.1 mean?

    We generally ask for double-blind, randomized trials as reference support for advertising claims. They should be controlled by either placebo or an active comparator, and should be statistically analyzed. In the case of active comparators, it is important to note that the drugs must be compared under the same conditions of use (s. 5.2).

  361. If we put a BRC regarding a patient program regarding our product in the product package, do we have to send the patient program for PAAB review?

    You should check with Health Canada regarding “labeling” requirements when you add information to the product package or inside the package. Some companies choose to send these BRC’s to Health Canada as labeling. If Health Canada accepts them, they are exempt from PAAB review. If not, it would usually be a promotional item subject to PAAB review. You can check with us. Remember federal labeling requirements apply to sample packaging. This would usually fall under Code s6.4.

  362. I was curious, to your knowledge , how many companies are currently operating within the PAAB meeting report exemption , either legitimately or otherwise . I know if anybody has this information it would be likely yourself. I am curious and was hoping you could shed some light on this issue

    There is no meeting report exemption. The PAAB did away with that supplementary guideline on April 1. PAAB Code section 6.6.a was rewritten and it allows an exemption from review for reports that are not advertising by the PAAB definition in Code s11.1 i.e. it is unbiased information not about the sponsor's products. Anything with some emphasis on the sponsor's products distributed to a broad audience in an unsolicited manner is "advertising" by the Food & Drugs Act definition of advertising and the PAAB Code definition. The content and relation to the sponsor are the key elements, not who the publisher is. Thus, if a company commissions a report about a study related to their product, it is most probably "advertising".


  363. A question has come up at our office regarding the authority of PAAB on non-RX&D companies regarding claims in promotional material. If a company is not a member, what measures exist to regulate promotional claims?

    The PAAB Code of Advertising Acceptance applies to all sponsors of advertising about healthcare products directed to healthcare professionals in Canada. The PAAB preclearance review mechanism is open to all healthcare product companies and is endorsed by Health Canada which remains the ultimate legal authority for healthcare product advertising. It is a voluntary code. Rx&D has made it mandatory, as a condition of membership, for their members to abide by the PAAB Code. If the PAAB finds or receives a complaint about advertising distributed by a non-PAAB-compliant company, we will contact that company. If the company does not wish to comply with the PAAB Code we send a complaint to Health Canada for legal/regulatory action. This does not happen often, indicating good compliance with the PAAB Code by healthcare product companies doing business in Canada.


  364. Do patient education tools that are distributed by physicians and endorsed and approved by a national medical society or organization of specialists need be approved by PAAB?

    I am not sure if the question is worded in a manner that was intended. I note "distributed by physicians" and "approved by a national medical society". If no pharma company is involved in the project in any way, the answer is "no". If a pharma company is involved in the sponsorship for production or distribution, it may seen as "advertising" subject to PAAB review if it appears to be promoting the sale of a product.


  365. Does a poster (developed by Canadian pharma company) intended to be used at an international conference need PAAB approval?

    Yes, if it originates in Canada and is controlled by the Canadian pharmaceutical company, it is subject to the PAAB Code. You can also see requirements for promotion/information at international meetings in the Health Canada guideline "The Distinction Between Advertising and Other Activities" that is available on the Health Canada web-site.

  366. Why can't information from a study be used if the reference appears in the bibliography section of the Product Monograph?

    All claims must be consistent with the Product Monograph. In the past, we have been advised by Health Canada that the inclusion of a study in a drug submission/bibliography section is not indicative of the approval of all parameters of that study. There must be proof of acceptance of the information evidenced by inclusion in the text of the Product Monograph. We can ask Health Canada for a product monograph interpretation. We have no control over when Health Canada answers and they may ask to see the advertising. The PAAB will not release submission information without the written approval of the submitter.


  367. If there are more than two studies that show the same outcome (e.g.: Improved BP reduction Vs a competing ARB) then do we still ask for disclosure of study parameters? Code s5.11 says this should not be required.

    Code s5.11 goes on to say that 'In no circumstances would extrapolation of the claim beyond the actual study be acceptable'. Often, if one does not specify the population (e.g.: men in a cholesterol agent comparison) then the reader might extrapolate the study results beyond the evaluated population. This would be true even if you had 50 studies showing the same result. Important information such as this should not be put in mice-type.


  368. We are getting a new indication that was based solely on a very small open-label study with a subjective endpoint. The study was not mentioned at all in the PM, however, it was published.

    We may consider allowing the use of the published, open-label study if they could prove to us that it was the basis of approval. To do this they would have to forward a copy of the S/NDS and any other pertinent correspondence from Health Canada. We could approach Health Canada on their behalf to resolve any contentious issues regarding the acceptability in advertising of their claims related to this study.


  369. If a fax were to be sent to physicians stating only the study name (I.e. ABC), what disease area it was studying (i.e. CHD mortality) and the major results (i.e. decreased mortality) but there was no drug mention; but provided a website for the study and a 1-800 number for further information, would this require approval? What if name of the study included both drugs that were compared (i.e. Alefacept Benzoperoxide Comparison)?

    Yes, the fax is "advertising" as interpreted by the PAAB Code because you are linking information to the web-site that is drug specific. The purpose appears to be to promote the sale of a particular drug. We note that if the product monograph did not include claims such as CHD mortality, you would be violating federal advertising law. You should not cite a study name that includes a claim that is not within the stated drug's authorized Product Monograph. When in doubt, telephone the PAAB and ask a reviewer your question.

Select a Category

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