FDA has released draft guidance for industry entitled “Direct-to-Consumer Television Advertisements—FDAAA DTC Television Ad Pre-Dissemination Review Program.”  The draft guidance is intended to assist sponsors of human prescription drug products, including biological drug products, who are subject to the pre-dissemination review of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 provision of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The draft guidance describes which TV ads FDA intends to make subject to this provision, explains how FDA will notify sponsors that an ad is subject to review under this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 in compliance with the FD&C Act. The policy applies to six categories: (1) initial TV ads for a product or a new indication; (2) ads for products requiring REMS; (3) ads related to Schedule II controlled substances; (4) the first add following a labeling change in a boxed warning, a contraindication, or a warning or precaution; (5) the first ad subsequent to an enforcement letter concerning a TV ad for the same product or one that leads an ad to be pulled from the airwaves for containing violations similar to the ones cited in the enforcement letter; and (6) an ad that FDA identifies as “subject to the pre-dissemination review provision.” These proposed TV ads will be subject to a 45-calendar day review clock by FDA. If FDA does not respond within the 45-day period, a company may release the ad, but risks enforcement action if FDA believes the ad violates the FD&C Act or its implementing regulations. The new policy would replace FDA’s current policy of requiring all DTC television ads to be submitted for review at the same time they appear on the airwaves. The comment period on the draft guidance ends May 14, 2012.