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DTC Prescription Drug Advertising Update

Merck Agrees to FDA Preclearance in Settlement over Vioxx

As part of a $58 million settlement reached with the Attorneys General of thirty states in regard to its promotion and marketing of Vioxx, Merck has agreed to substantial restrictions on its DTC advertising.  In the settlement, it has agreed to submit all ads for new drugs to the FDA for preclearance.  It has also agreed to follow any FDA recommendations for a delay in airing television ads for pain relief drugs.    

Just last year, Congress, as part of drug safety legislation, considered mandatory FDA preclearance and a two- or three-year moratorium on drug ads.  These provisions, which raised significant constitutional issues, were later removed in favor of granting the FDA enhanced civil monetary penalties for false and misleading ads and allowing drug companies to voluntarily submit ads for review.  The FDA is still working on implementing these new powers.

Energy and Commerce Committee Sends Letters on Ad Practices to Drug Companies

As a follow up to the May 8, 2008 Oversight and Investigations Subcommittee hearing on DTC ads for Vioxx, Lipitor, and Procrit, the Chairman of the House Energy and Commerce Committee, John Dingell (D-MI), and the Chairman of the Oversight and Investigation Subcommittee, Bart Stupak (D-MI), have sent letters to the CEOs of four drug companies and the Pharmaceutical Research and Manufacturers of America (PhRMA) requesting information on drug marketing practices. 

Specifically, the letters ask the companies if they will:

The letters also indicate that a second hearing, at which the CEOs will be asked to testify, will be held. 

If you have any questions, please contact 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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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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