Further to response to question 726, the FDA in the US has issued Guidance on Medical Communications That Are Consistent With the FDA-Required Labeling - Questions and Answers. This approach outlines that information about long-term safety/efficacy of products approved/cleared for chronic use may be considered "consistent with" the FDA-required labelling, if features of the use of the product (indication, population, dosage and administration etc) in the long term study are consistent with the authorized details in labelling. Given this science-based approach, it is not clear to me why PAAB's interpretation would be that this information is not consistent with the TMA in the context of a chronically used product. Can you elaborate on the rationale?

The current approach taken by PAAB is based on consultation with Health Canada based on the duration of time which they have assessed the product for safety within the Canadian population. It is not uncommon for the approach to advertising to be different within other jurisdictions such as the US. Having said that, you are likely aware that we’ve been actively engaging in global benchmarking activities in order to narrow the gap, were possible between Canada and other jurisdictions. We came across the FDA’s CFL guidance through those global benchmarking activities. We are currently looking into ways that this approach (or parts of it initially) can be incorporated into the Canadian regulatory landscape. We’ll soon be preparing a proposal for key stakeholders, which will include Health Canada. Keep in mind that PAAB review practices are not determined unilaterally by PAAB in a bubble.


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