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  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 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?
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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?

Scheduled Pinned Locked Moved FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    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.

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