352 - Can you please explain the rationale behind not being "promotional" in branded patient-directed material? Product claims would seem to promote adherence, and therefore be beneficial to the patient.

  • The PAAB code section you are alluding to is s6. This provision is intended to align with the federal advertising regulations for prescription products which only enable prescription drug advertising directed to HCPs and restricted consumer advertising (the latter being limited to name, price, and quantity). There are no enabling provisions for promotion to patients. Patient information must be consistent with part III of the product monograph (and this "information" is non-promotional). This information can support adherence by educating patients about how to use the product appropriately.