The Food and Drug Administration (FDA) has issued draft guidance for industry titled “Direct-to-Consumer Television Advertisements—FDAAA DTC Television Ad Pre-Dissemination Review Program.” Comments are requested by May 14, 2012, to ensure consideration before the final draft is prepared. The guidance “is intended to assist sponsors of human prescription drug products, including biological drug products, who are subject to the pre-dissemination review of television advertisements (TV ads) provision of the Federal Food, Drug, and Cosmetic Act.” The guidance addresses “which TV ads FDA intends to made subject to this provision, explains how FDA will notify sponsors that an ad is subject to review under this provision, and describes the general and center-specific procedures sponsors should follow to submit their TV ads to FDA for pre-dissemination review.”
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FDA issues draft guidance on direct-to-consumer TV ads for prescription drugs
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