Dear PAAB reviewers, I have a question regarding the "Clarification regarding digitization of APS: Helping healthcare product manufacturers plan for the evolving COVID-19 operational context" guidance - several of our clients have pulled back on rep visits to HCPs in-person in light of COVID and have asked us how they can disseminate DTC waiting room materials to these HCPs in a digital manner. Some of the pieces are print, which can be converted to digital, and others are waiting room videos intended to be loaded onto waiting room ipads. These materials have all been ASC-approved so how can these resources be provided to HCPs via email in a manner that is not contravening the PAAB code?

Content provided to the patient through the healthcare professional (for example, waiting room material) would be deemed service oriented vehicles (SOV) and therefore be subject to the PAAB code and review. The intended use should be clearly conveyed upon submission so that the reviewer is clear if a DTC and SOV review are required concurrently.


Leave a Reply

Your email address will not be published. Required fields are marked *

19 − fifteen =

Scroll to top