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.
61 - If an APS makes a usage claim (number of prescriptions or patient-years, for example) for an agent and shows the product logo, but provides no therapeutic claims for the product, does the indication have to be included? Other than an acceptable reference for the usage claim, is there any other balance copy necessary?
-
Although there are no therapeutic claims for the product per se, the usage claim based on marketshare data is considered a claim of merit and viewed as promotional. Therefore, for clarity and completeness as per PAAB Code 2.1 & 2.1.2, the APS should state what the product is indicated for. As for the fair balance requirement, we would need to see the APS in proper context (with visual and text) in order to determine what balance copy is necessary. Keep in mind that fair balance requirement is also based on the product monograph.