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.

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.

"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.