Ask PAAB

137

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

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

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

136

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

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

135

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

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

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

   

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

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

134

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

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

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

133

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

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

132

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

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

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

131

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

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

130

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

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

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

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

129

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

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

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

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

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

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

128

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

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

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

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