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.

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.

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.

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.

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. If you place a PAAB logo on APS written in other languages, the logo should be accompanied by copy indicating that the copy was reviewed in English and then translated to language X.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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/).

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.

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.

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.

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.

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).

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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).

As follow-up to question 93 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.

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.

Further to question 83. It is my understanding that if an item is reviewed as DTC by the PAAB, the sponsoring company receives comments, but no approval code and thus no expiry date. I recently attempted to re-PAAB an item which had been through DTC review, and was told that it did not expire and thus did not need re-PAAB. Can you please clarify?

Your understanding in the first sentence is correct and therefore I think the PAAB gave you the proper answer in the second sentence. Unless you changed the content of the DTC item there would be no need to re-PAAB it. You should tell us during submission entry if the item is new in that something was changed.

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.

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.

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.

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

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.

If an APS has been reviewed as DTC and therefore no expiry/approval code was provided, does it need to be submitted again every 12 months?

It is important to distinguish the regulatory classification of the material. If the PAAB provides a Direct-to-Consumer Advertising and/or Information review opinion based on the Health Canada guidance document “The Distinction Between Advertising and Other Activities” and no expiry code is given, there is no need for renewal of the material. On the other hand, Patient Information directed to patients through health professionals is covered by PAAB Code section 6.4, should show the PAAB logo, and would require renewal after 12 months after the PAAB approval date.

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.

If we want to provide samples of hand sanitizers to nurses at a show does the insert have to be approved by PAAB since the product is not a prescription or OTC drug but does carry an NPN? The question would be the same for disinfecting products.

By federal law the “insert” may be either “advertising” or “labeling” and this would affect its status regarding PAAB review. Please see section 1 SCOPE in the PAAB Code of Advertising Acceptance available at http://www.paab.ca/. The PAAB Code applies to “advertising” (defined in s11.1) that is directed to health professionals and it covers prescription, biologicals, nonprescription and natural health products. In this case, if the “insert” is deemed to be “advertising”, it would require PAAB review. Advertising for sanitizing and disinfectant products that have a DIN or NPN are covered by the PAAB Code. Please remember that federal sampling regulations should be adhered to. If the company submitted the “insert” to Health Canada as part of the sample package labeling with respect to federal regulations, it would not require PAAB review.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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)

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.

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.

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.

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.

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.

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.

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.

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.

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).

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).

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

• 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."

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.

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.

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.

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.

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.

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.

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.

Regarding Representative distribution of CME Accredited Materials:

Can a program supporter have their representatives distribute or base discussions on CME accredited materials ?

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.

If I look at the these points it is unclear to me if indeed there can be representative involvement if so , at what level? :

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.

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.

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.

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.

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.

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.