Ask PAAB

327

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

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

326

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

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

325

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

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

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

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  Yes.

324

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

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

323

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

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  As a general answer (not specific to any platform such as YouTube), when a link is distributed in a controlled manner limited to HCPs and it is the only way to access the file, then file access control is adequate by definition. I am assuming the link would not be simple for a consumer to guess.

  Feel free to give me a call to discuss whether this is possible to accomplish on YouTube. The ease of video sharing and posting on websites/blogs may make this challenging on YouTube.

322

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

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

321

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

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

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

320

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

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

319

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

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

318

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

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