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FDA Proposes New Rule for "Major Statement" in Broadcast DTC Ads

The Food and Drug Administration (FDA) has proposed a rule to implement the new requirement that the "major statement" in DTC television or radio ads relating to the side effects and contraindications of a pharmaceutical product be presented in a "clear, conspicuous and neutral manner."  The FDA is also proposing standards that the agency would consider in determining whether the "major statement" in these ads is presented in such a manner.  This new requirement was added by the Food and Drug Administration Amendments Act of 2007 (FDAAA). 

Comments on the proposed rule are due by June 28, 2010.

ANA was actively involved in the 2007 legislation to protect the rights of companies to market these important products effectively to consumers.  We may be filing comments on the proposed rule and need your input. 

Please contact Dan Jaffe (djaffe@ana.net) or Keith Scarborough (kscarborough@ana.net) in ANA's Washington, DC office at (202) 296-1883 with your feedback on this proposal.

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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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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