Unauthorized Use of Content on this Site: 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 correspondence—are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content, or using it for model training or any related purposes, is strictly prohibited without the express prior written consent of PAAB. This includes, but is not limited to, the use of such materials in automated systems, machine learning models, or artificial intelligence applications.
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?
-
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).