May 23rd, 2012

The End Of DTC TV Ads? Sanofi Says Maybe

By Ed Silverman

Two months ago, the FDA issued a draft guidance that stipulates when drugmakers must submit their TV ads for agency review. The FDA has had the authority to review ads ever since the Food and Drug Administration Amendments Act of 2007 was enacted and the recent draft guidance makes clear that reviews are required for direct-to-consumer ads for a variety of situations.

These include initial TV ads for any prescription drug; an initial TV ad for a new or expanded indication; all TV ads for drugs that are subject to a Risk Evaluation and Mitigation Strategy, or REMS; all TV ads for Schedule II controlled substances; the first TV ad following a safety labeling update that affects a boxed warning, contraindications, or warnings and precautions section, and the first TV ad following an enforcement letter.

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