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FDA preparing new prescription drug ad guidelines

U.S. health officials said on Monday they hope to publish new draft guidelines by year's end that will lead to better presentations of prescription drug risks and benefits in television commercials and magazine ads.

Direct-to-consumer advertising of prescription medicines exploded in 1997 after regulators clarified guidelines. Yearly industry spending now totals about $3 billion a year to promote treatments for everything from depression to impotence to allergies.

Critics charge the ads lead to unnecessary prescriptions and drive up health care costs, while proponents say they educate the public and prompt many to seek treatment who otherwise would not.

Food and Drug Administration officials said they need more information to fully assess that question but saw widespread sentiment that information could be presented more clearly to consumers.

Summaries in magazines can be hard to read, and television ads may not properly balance benefit and risk information, some officials and researchers said at an FDA meeting called to hear research on the ads' impact.

"I think everyone agrees the (summary) format is not the best," said Tom Abrams, director of the FDA's division of drug marketing, advertising and communications.

The FDA is working on new guidelines for summaries of drug risks and benefits that must accompany the ads and hopes to issue them by the end of the year, Abrams said.

The agency also will continue to encourage drug makers to use language consumers can understand, Abrams said.

"Our hope is that industry will voluntarily do this. It seems to be in their best interest," Abrams said.

One problem may be that ads often mention a list of side effects, placing equal emphasis on relatively minor problems such as dry mouth and potentially serious complications such as liver damage, said Edwin Slaughter of Rodale Inc., publisher of Prevention magazine, which has surveyed consumer attitudes toward the ads.

The FDA's own research, as well as other data presented Monday, found mixed views on the ads' overall usefulness.

While some doctors admitted feeling pressured to prescribe medicines that patients requested after seeing an ad, they are not being overwhelmed, said Kathryn Aikin of the FDA's division of drug marketing, advertising and research.

"We are not seeing hoards of people running to a doctor because of an ad," Aikin said.

Pfizer Inc., which has blanketed the airwaves with ads for impotence fighter Viagra and cholesterol-lowering drug Lipitor, said its research proved consumers benefited from the ads, in part because the promotions prompted people to talk to their doctors about treatments.

"The unspoken truth about advertising of medicines is that it constitutes one of the largest and most successful public health campaigns in U.S. history," Pat Kelly, president of Pfizer U.S. Pharmaceuticals, said in a statement.

Posted on aef.com: September 25, 2003


Lisa Richwine, Reuters. September 22, 2003

Copyright © Reuters 2002. All rights reserved.