FDA KICKS OFF DTC DRUG AD HEARING

'Genie Is Out of the Bottle' Hearing Is Told

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WASHINGTON (AdAge.com) -- A critical two-day public hearing on the future of direct-to-consumer drug advertising kicked off this morning with a key Food and Drug Administration official saying DTC promotions were here to stay.

"Given that it is likely to remain, the ongoing question is can [DTC ads] be made better or more useful," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "The genie is already out of the bottle."

A chance to present findings
The two-day forum is being held at the

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400-seat conference center at the National Transportation Safety Board, a stone's throw from The Mall. The meeting will give parties who have conducted research on DTC advertising a chance to present its findings to the FDA and to the public.

The FDA will consider the data, as well as its own research, to determine if the agency's current regulatory approach should be modified, including whether the guidance on DTC advertisements should be withdrawn, continued or modified to reflect the FDA's current thinking.

FDA Commissioner Mark McClellan has said the agency will use the findings from the public hearings to determine new guidelines regarding DTC advertising later this fall.

"We're looking forward to hearing the research on this topic," said Thomas Abrams, director of the Division of Drug Marketing, Advertising and Communication. "This meeting is not to discuss policy or opinion on DTC, but to gather data."

Common misconception
Mr. Abrams said a common misconception with DTC advertising is that it began in 1997 and is a relatively new phenomenon, leading to regulatory problems. But Mr. Abrams said the first DTC ads actually appeared in the early 1980s, one for an arthritis medication and one for a vaccine. Taken aback, the FDA asked the pharmaceutical industry for a voluntary moratorium on DTC advertising to allow time to review the process. That moratorium was lifted in 1985.

"Then came 1997, and people thought we changed laws or loosened regulations," Mr. Abrams said. "What the FDA did was provide clarification to the existing requirements. In 1999, the federal registry announced the final version of broadcast guidance."

Opponents of DTC advertising contend that consumers do not have the expertise to accurately evaluate and comprehend prescription drug advertising, and that DTC promotion is typically misleading because it fails to adequately communicate risk vs. reward information.

Proponents argue that DTC promotion is of educational value, will improve the physician-patient relationship and will make consumers aware of conditions they have that could benefit from treatment.

Patient as consumer
"The phenomenon must be seen in the larger picture of the evolution of the patient and consumer's role in their own health," Ms. Woodcock said. "DTC promotion is neither wholly negative nor wholly positive. This meeting is convened to provide a forum on the research's impact."

Ms. Woodcock said a basic issue is the effect on the doctor-patient relationship.

"It is of some concern that an ad would make an individual so confident as to demand a certain drug, or to doctor-shop until they found a physician willing to prescribe that medicine," she said.

The public forum continues today and tomorrow with presentations that include national surveys, effects of DTC advertising on prescribing medication and the advertising effectiveness.

'The unspoken truth'
"The unspoken truth about advertising of medicines is that it constitutes one of the largest and most successful public health information campaigns in U.S. history," said Patrick Kelly, president of U.S. Pharmaceuticals for Pfizer, which will make a major presentation tomorrow afternoon.

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