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142 - If we are providing co-pay assistance program through a third-party, do communications informing physicians/HCP of the program have to go through PAAB?
FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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PAAB Code section 1.5 allows a review exemption for formulary announcements such as "now on formulary" not linked to a therapeutic message in any way. Covered uses are deemed to be therapeutic messages. Generally co-pay assistance programs would mention a drug and a therapeutic use and would fall under Code as "institutional" messages with product mention which would require review. The co-pay message could be part of a product ad with claims and would requires a review.
