708 - If Product-A is a combination of Drug-B and Drug-C, can the mechanism of action information from the Drug-B and Drug-C Product Monographs be used in Product-A advertising? The Product Monographs for combination products usually contain less information regarding their components (for brevity), however mechanisms of action should be identical regardless of formulation.
Jennifer Carroll last edited by
The review of mechanism of action claims for drug A would be based on the Product Monograph for drug A. We would not accept the assumption that combining the two products does not in any way impact the mechanism of action of either of the individual drugs. This concept would require direct support from the drug A PM, in which case, content from drug B and drug C PMs may be considered. This assessment would be conducted on a case-by-case basis and would depend greatly on the information/language in the drug A PM. For example, if the PM for drug A says “Please refer to the individual product monographs for Drug B and Drug C for more information on the mechanism of action” then we could consider the MOA content from the respective PMs