FDA chief pledges changes to direct-to-consumer advertising guidelines

Physicians welcome better enforcement and easier-to-understand summary information, but most would also like to see an increase in patient educational value.

By Victoria Stagg Elliott, AMNews staff. April 28, 2003.

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The Food and Drug Administration is working to improve rules governing direct-to-consumer advertising of prescription drugs.

The agency is aiming to better enforce guidelines and to become a more effective deterrent to misleading ads, according to a speech made earlier this month by FDA Commissioner Mark B. McClellan, MD, PhD.

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"Physicians and others are concerned that consumers may not always get a balanced view of the benefits and risks of a product," said Dr. McClellan, speaking to the Food and Drug Law Institute, an association of manufacturers and suppliers subject to FDA regulation.

Specifically, the agency is working on new materials to guide manufacturers in providing consumers with summary information, based on the drug labels, that is more useful and easily understood. The agency is focusing on ensuring that FDA warning letters will strengthen enforcement efforts in legal actions, providing more effective deterrence to recurrent patterns of misleading advertising.

The FDA declined to reveal any further details, but physicians said such steps would be a welcome move.

"We applaud that," said AMA President Yank D. Coble Jr., MD.

Doctors have been complaining for years that direct-to-consumer advertising costs them time when they have to address patients' concerns raised by the ads. They also say the ads cost the health system money by ginning up consumer demand for new and often expensive prescription drugs when less advertised and less pricey ones may be just as good. Several studies support the connection between DTC ads and increases in drug spending and utilization.

"Many advertisements confuse patients and increase the cost of medical care," said J. Willis Hurst, MD, professor emeritus for the Dept. of Medicine at Emory University in Atlanta.

Resolutions calling for bans on such ads are a regular topic of debate at AMA meetings, but have yet to pass, primarily because of the unfeasibility of a ban. Also, physicians recognize that DTC ads can bring patients into the office for help with medical conditions that they wouldn't otherwise have brought to their doctors' attention.

"The fact is that direct-to-consumer advertising does provide a service to us," said Michael Fleming, MD, president-elect of the American Academy of Family Physicians. "It does make people aware of diseases."

What many physicians would like to see are significant changes in the advertisements themselves.

"Our fighting for it to go away isn't going to work," said Stuart Gitlow, MD, MPH, an addiction psychiatrist from Providence, R.I. "Let's work for something that the public, the [drug companies], and the doctors can all live with."

At the AMA 2002 Interim Meeting, the Association adopted a policy on DTC advertising that calls for an emphasis on patient education about select diseases rather than a single drug, and for a clear message that any decision about whether to take a particular drug be made in consultation with a physician.

But in addition to changes in the rules, many doctors are particularly keen to see improvements in enforcement, as promised by Dr. McClellan. A report from the General Accounting Office found that regulatory letters meant to inform companies that an ad was in violation of FDA rules were sometimes sent out long after the ad campaign was over.

"Any serious effort to address this will require a major infusion of resources because timing is everything," said Richard Kravitz, MD, MSPH, director of the Center for Health Services Research in Primary Care at the University of California, Davis.

A Pharmaceutical Research and Manufacturers of America spokesman had no comment because the FDA's exact plans were not available.

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