638 - Would the use of a publication for a clinical trial evaluating two different head-to-head treatment comparisons be allowed in promotional materials if only one of the head-to-head comparisons is in alignment with the TMA? More specifically: •The comparison of Product A versus Product B is in alignment with the TMA for Product A i.e, a comparison versus another product in the same therapeutic class as Product B is included in the TMA; the primary endpoint in the publication is the same as a secondary endpoint included in the TMA for a pivotal study; same patient population. •The comparison of Product A versus Product C is not in alignment with the TMA indication for Product A. •Would the comparison of Product A versus Product B be allowed in promotional materials for Product A?
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Before reading this answer, please take some time to look at the other Ask PAAB questions around “off-label” content in references, specifically 336, 175 and 45. Off-label promotion would contravene section 9.2 of the Food and Drugs Act.
If, in your described study, we were to assume that all other aspects of the code are met around the quality of the study, it may be possible to present the on-label findings in a restricted manner that does not include the off-label comparisons. Note that distribution of a study reprint would most likely not be acceptable (as it would be deemed promotion of off-label use). In other words, the information you’ve provided alone would not preclude use of the study (except as a piece accompanied by the study such as a reprint holder). Of course, our final ruling will not be based only on these stated factors. For any study, many study-specific factors influence whether it is acceptable as the evidentiary basis for a particular claim/presentation. This is particular true for a complex study like the one you’ve described. The written opinion service (see fee schedule on our website) would provide you with a more robust assessment of whether the particular study which inspired this question can be used for the intended purpose and in the intended context.
