Three New FDA Guidances Expected to Spur Increased Direct-to-Consumer Advertising of Drugs and Devices

Author:Mr Matthew Boyd Van Hook
Profession:Holland & Knight LLP

Originally published March 18, 2004

FDA has published three new draft guidances intended to further loosen constraints on Direct-to-Consumer (DTC) print and broadcast advertising. Comments on the guidances due Monday, May 10, 2004. Although FDA guidances are nonbinding even when finalized, these initiatives were announced by then FDA Commissioner Mark McClellan, and they clearly signal FDA's policy and enforcement intentions. Drug and device manufacturers, and the print and broadcast advertising industry, should begin to plan now how best to take advantage of the increased flexibility to simplify required risk information, incorporate user-friendly language, and run device and "disease awareness" ads.

The three guidances are discussed individually below, following background on FDA's evolving approach to regulating DTC advertising.


FDA has long grappled with the appropriate role of direct-to-consumer advertising of regulated drugs and devices. The issue involves the intersection of First Amendment commercial speech rights, as well as legal concepts unique to prescription medicines (e.g., the role of physicians and the learned intermediary doctrine). In 1997 FDA issued proposed guidance that clarified how drugs reasonably could be advertised on television. Instead of running the entire drug label (as had long been required for print ads), FDA allowed broadcast ads to feature a much shorter "major statement" of risks, along with "adequate provision" for consumers to obtain the full story if they desired (e.g., via toll-free phone, the Internet or in a major magazine ad).

These latest guidances confirm FDA's commitment to allow, and even facilitate, DTC advertising. At first, FDA's changing practices were driven largely by increasing recognition of First Amendment commercial speech rights. More recently, however, FDA has emphasized the consumer benefits of DTC advertising. At a September 2003 FDA-sponsored meeting, the agency presented research on the effect that DTC promotion has on public health, including increasing patient awareness, stimulating doctor visits, and helping to identify previously undiagnosed conditions. In releasing the current guidances, FDA cited results of research showing that 87 percent of patients who visited a doctor as a result of a drug ad actually had the condition indicated for that drug.

Former FDA Commissioner McClellan consistently has emphasized his support for agency actions to empower consumers with more and better information. There is a recognition that the agency's longstanding rules and practices run counter to this...

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