May 25th, 2012

FDA Guidance On DTC TV Ads Is Unconstitutional?

By Ed Silverman

Two months ago, the FDA issued a draft guidance that stipulates when drugmakers must submit their direct-to-consumer TV ads for agency review. These include initial ads for any prescription drug, or for a new or expanded indication; all TV ads for drugs that are subject to a Risk Evaluation and Mitigation Strategy; all TV ads for Schedule II controlled substances, and the first TV ad following a safety labeling update or an enforcement letter, among other things (here is the draft guidance).

“These categories reflect a risk-based approach that will enable the Agency to leverage its limited resources to best protect the public health by ensuring that certain high risk and high impact TV ads accurately and effectively communicate key information about advertised products, including their major risks and indications,” the FDA wrote in its March draft guidance.


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