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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The piece you have described would be reviewed as an editorial (i.e. "unbranded" piece) under PAAB code s7.6. As a general principle, advertising should promote the sponsor's product by its own merits rather than by calling attention to the limitations of competitors (whether perceived or factual). The hypothetical piece you are describing risks being disparaging. Clients are sometimes surprised to learn that "Factual" and "misleading" are not necessarily mutually exclusive.Also note that class/category claims are generally not accepted. Given the variability within any given product classes and categories, it is misleading to make sweeping class/category statements.Finally, drug claims should not be based on review papers or expert opinion. The opinions of an individual are not necessarily consistent with broader current medical opinion. Comparative efficacy and safety claims require double blinded head-to-head RCTs.
