FDA Draft Guidance Establishes 45-Day Review Period for Certain Direct-to-Consumer TV Advertisements

On March 13, 2012, the Food and Drug Administration (FDA) published a draft guidance for industry to address direct-to-consumer (DTC) television promotions of prescription drugs and biologics. The draft guidance, entitled Direct-to-Consumer Television Advertisements – FDAAA DTC Television Ad Pre-Dissemination Review Program, seeks to implement the Food and Drug Administration Amendments Act of 2007 (FDAAA), which gives the FDA authority to require television advertisements be submitted for agency review at least 45 days prior to airing. Comments and suggestions on the draft guidance may be submitted to the FDA through May 14, 2012.

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