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FDA Releases Draft Guidance for DTC Prescription Drug TV Ads

The Food and Drug Administration (FDA) recently released draft guidance on direct-to-consumer television advertisements.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.

Legislative and Regulatory Issues Tracking

ANA's Washington, DC office works to protect the ability of all marketers to communicate effectively with consumers.   The scope of legislation, regulations, and court cases impacting the marketing community continues to be extremely broad, extending to issues as diverse as online privacy, prescription drug advertising, restrictions on the tax deductibility of advertising costs and the regulatory powers of the Federal Trade Commission.

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Compendium of Legislative, Regulatory and Legal Issues

ANA's Washington, DC office plays a leading role in protecting the ability of all marketers to communicate effectively with consumers. At the end of each year, we prepare a Compendium which describes our efforts on the broad range of issues we have faced. 

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Alliance for Family Entertainment

The ANA Alliance for Family Entertainment (AFE) is a coalition of national advertisers, supported by the ANA, which represents almost 40% of all U.S. television advertising dollars..

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SAG/AFTRA

ANA and the American Association of Advertising Agencies (4A’s) conduct broadcast talent negotiations with the Screen Actors Guild (SAG) and the American Federation of Television and Radio Artists (AFTRA) through the Joint Policy Committee, or JPC.

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