November 2, 2005

Pharmaceutical companies are ready to legally challenge any efforts to eliminate direct-to-consumer (DTC) advertising, industry officials said during the first day of a two-day FDA public hearing on DTC activities. Agency officials responded that they will not seek to prohibit DTC ads, but are considering new ways to regulate the practice.

During numerous presentations given recently, industry officials warned the agency that the Administrative Procedures Act and the First Amendment give the private sector the legal backing to defeat any efforts to eliminate DTC advertising. According to J. Patrick Kelly of Pfizer and John Kamp of the Coalition for Healthcare Communication, an industry group, any efforts to eliminate DTC advertising could be met with lawsuits. Kamp went a step further, arguing that any agency efforts to implement a moratorium on advertising new drugs would be challenged in court as well.

Industry officials, including Kelly and Kamp, argued that DTC advertising is necessary to ensure that patients are aware of drugs that can help them address various illnesses and that informed patients result in a more accurate diagnosis. Efforts to eliminate this information smacks of "paternalism" on the FDA's part, Kamp added.

But Robert Temple, the director of the FDA's Office of Medical Policy within the Center for Drug Evaluation and Research, told FDAnews that the agency did not propose prohibiting DTC ads because of these legal concerns. Instead, the FDA wants to ensure DTC ads are of higher quality, including having a more balanced message. Temple also wants to ensure that improved advertising helps to increase attention on under-treated problems, including high-blood pressure, with an eye toward long-term changes in patient behavior.

The agency is considering several options for changing DTC policy, including new regulations and guidance. While the FDA has not decided whether regulations are necessary, the fact that advertising regulations were created many years ago and only address advertising to professionals, rather than consumers, may mean new rules are in order, Scott Gottlieb told FDAnews. However, the law requires that the agency enter into on-the-record rulemaking, which can take many years to complete, making such a move very difficult to do, Gottlieb said.