Claims & Support/References for Claims
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The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB),
including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB
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292 - Hi, I'm sending this request for clarification on the new PAAB code: section 3.1.6 of the new code states: 3.1.6 Footnotes in close proximity may be used to augment information presented in the body copy. Information that is important for a clear and accurate understanding of a product claim must not be relegated to a footnote. Example - an indication or dosage that is limited or that is restricted to a specific group of patients. compared to the previous code which states: 3.1.6 Footnotes in close proximity may be used to augment information presented in the body copy. Information that is important for a clear and accurate understanding of the indications or dosage of a product must not be relegated to a footnote. Example - an indication or dosage that is limited or that is restricted to a specific group of patients. can you please clarifiy the implications or give examples on how the new point 3.1.6 differs from the old one? thank You!
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285 - Hi, I have a study (contained in the PM) in which only 2 versions of the same drug are being compared. The PM contains baseline and last visit levels of an endpoint marker for both drugs. In a branded detail aid, am I allowed to show a graph (baseline vs. last visit) for just one of the drugs? Or do I have to show the same type of baseline vs. last visit graph for both drugs? Thanks!
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284 - Hi Patrick! We're looking to collect data from a patient survey related to dosage and administration. Ultimately, we would like to disseminate this information to HCPs so they are more aware of their patient behaviour and preferences in relation to their treatment. Could you suggest a way we would be able to do this? Thanks
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278 - In an APS for a prescription product, if you want to present side-by-side comparisons of non-therapeutic information from Product Monographs (e.g., product properties, use limitations) as per section 5.10.2, do you need to include all of the approved products in that indication or is it acceptable to show only selected products (e.g., two out of five available agents)? If all products must be mentioned, does that also include generics or only branded products? Thanks!
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273 - Hi, I will be following PAAB regulations to ensure that an unbranded disease information piece qualifies as being 'PAAB exempt'. I will also be submitting it to PAAB (simply to get a letter saying that it is PAAB exempt). Is it necessary that the review papers we are referencing DO NOT make mention of treatement options anywhere as well (even though our APS will not make mention of treatment options/categories)? Or is it ok if the review paper discusses treatments so long as we don't make mention of them in the APS?
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265 - Please explain "Claims relating to PRO endpoints must appear clearly within the context of the Health Canada approved indication." Does this mean that data from PROs must be in the PM, or just that the PM must address the outcome being assessed (e.g. "Drug X treats condition Y, and the pain from condition Y", for the PRO of pain reduction).
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213 - Dear PAAB, I am curious about creating unbranded educational material around Subsequent Entry Biologics. We know that there are potentially a lot of issues that SEBs can have considering the nature of the manufacturing process. Is it acceptable to educate physicians on the challenges, risks, and non-identical nature of SEBs vs. orignial product, using review and 'expert opinion' articles in an unbranded piece? Alternatively, if we had a study that was done that showed these issues would we be able to use that? Or is it, if Health Canada has approved it then we can't say anything to infer challenges and risks? Many thanks.
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191 - I understand that a Canadian consensus guideline is an acceptable, authoritative source. Correct? If the consensus is published in a peer-reviewed journal, but it is not explicitly called a "guideline" in the title, is this acceptable? (E.g., "Canadian consensus on..." or "Canadian clinical guidance...")
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