512 - Can you please clarify why product MOA can only come from the TMA, and not published, peer-reviewed in vitro studies? MOA is frequently characterized post-NOC, particularly for products where ‘the exact mechanism of action is unknown’.

  • The qualitative description of a product’s action in advertising must be consistent with its current Terms of Market Authorization in order to satisfy PAAB code section 3.1. Therefore, if the MOA info in the TMA is outdated (e.g. because the MOA is no longer unknown), the TMA is required to be updated in order to include that info in drug advertising.