FDA Releases Draft Guidance for DTC Prescription Drug TV Ads

The Food and Drug Administration (FDA) recently released draft guidance on direct-to-consumer television advertisements.  It basically follows the Food and Drug Administration Amendments Act of 2007 (FDAAA) and sets up specific requirements for FDA review and comment on ads.  The industry worked hard to significantly and successfully revise that legislation from its earlier incarnation, which would have set strict requirements for ads, such as a three year moratorium on ads for new drugs, preapproval of ad content, and “black triangle” warnings symbols for new drugs.  We would like your input if you think we should weigh in on this draft proposal.  Comments are due by May 14, 2012.

We are considering filing comments.  If you have any questions or suggestions, you can reach Dan Jaffe in ANA’s Washington office at 202-296-2359 or at djaffe@ana.net.