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FDA to Revisit Drug Marketing

After easing rules that have allowed pitches for prescription medicines to boom, the agency now wants to hear how ads can be regulated.

November 02, 2005|Ryan G. Murphy | Times Staff Writer

WASHINGTON — Concerned about the direct marketing of prescription medication to consumers, the Food and Drug Administration began collecting ideas Tuesday on how such advertising could be regulated.

"A lot has happened in the last decade with direct-to-consumer advertising, and we believe it's time to receive additional input," said Dr. Janet Woodcock, the FDA's deputy commissioner for operations. "It's critical, from a public health standpoint, that the advertisements are truthful and balanced."

Since 1997, when the FDA relaxed the rules on marketing prescription medicines, ads for treatments of such ailments as depression, erectile dysfunction and chemotherapy-related anemia have moved from medical journals to television networks and consumer magazines, creatively describing the benefits of a more cheerful mood, enhanced virility and increased energy while fighting cancer.

Today, direct-to-consumer advertising is a $4.1-billion-a-year industry, and numerous studies have demonstrated that such marketing increases sales of specific drugs.

But debate over the effectiveness and accuracy of the ads has polarized consumer groups, which are seeking stricter regulations, and drug manufacturers, which contend that such marketing is free speech.

In two days of hearings this week, the FDA is looking for comments from all sides -- pharmaceutical executives, university researchers, consumer advocates and medical experts.

"The whole subject ... is somewhat controversial. Some people hate it, some people like it," said Dr. Robert Temple, director of medical policy for the FDA's Center for Drug Evaluation and Research. "We think it's legal under law, but we still get to describe its content and regulate its content. We want to hear from people about how to do that, especially if they have data."

The FDA is considering ways to help advertisements communicate complicated medical information in a more comprehensible way, Temple said, although there is no specific plan for new regulations or guidelines.

Supporters of this form of advertising say that direct promotion to consumers provides useful information and allows patients to initiate conversations with their doctors.

"Informed dialogue between patients and healthcare professionals is the single most important element of health communications," said J. Patrick Kelly, president of Pfizer Pharmaceuticals. "We believe that [direct-to-consumer] advertising is an important and effective channel for this communication. It helps patients work with their healthcare professionals to make important decisions about their health."

John Kamp of the Coalition for Healthcare Communication, which includes national advertising and publishing groups, argued that advertisements for drugs should not be held to a stricter standard.

"Cars, like drugs, are recalled for safety reasons," he said. "Cars, like drugs, have safety issues. It would make no more sense to ban drug ads than it would to ban car ads. Such schemes are undermining the very integrity of the drug approval process and need to be rejected outright."

Opponents of the ads are concerned that some content may be distracting or misleading. Advocates of stricter FDA regulations argue that consumers have wasted millions of dollars and even put their health at risk by taking medications they may not need.

According to research presented by Michele Spence of Kaiser Permanente, patients who saw drug ads and then asked their doctors for the drug were much more likely to receive the prescription than patients who never mentioned the ad.

Ruth Day of Duke University said her research had shown an unfair balance between benefits and risk in some direct-to-consumer advertisements.

After reading or viewing an ad, she said, "80% of people can recall what a drug's benefits are; 20% can recall what the side effects are. We need to improve the cognitive accessibility of risk information."

The hearing continues today.

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