The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB),
including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB
correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system.
Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly
prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.
406 - In an unbranded context, is it possible to use a guideline treatment algorithm that recommends drugs that are off label for the condition it pertains?
Terms of Market Authorization
1
Posts
1
Posters
356
Views
1
Watching
-
No. The editorial APS provisions of the PAAB code requires that “information on a specific drug is consistent with the current Product Monograph”. Editorial advertising is not the forum for off-label advertising of the sponsor’s product. Note also that the drug class in which the sponsor has a vested interest may not be promoted off-label (e.g. promoted in a manner which is inconsistent with the monographs of all products in that class).
