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FDA: Doctors Must Report Misleading Drug Ads

Wed, 05/12/2010 - 8:05am
Matthew Perrone, AP Business Writer

WASHINGTON (AP) -- The Food and Drug Administration said Tuesday it will begin asking doctors to keep an eye out for misleading drug advertisements as part of the agency's latest effort to police the pharmaceutical industry's multibillion-dollar marketing machine.

The agency's "bad ad program" urges doctors to report ads and sales pitches that violate FDA rules. Drug companies are legally required to present a balanced picture of a drug's benefits and risks in promotions, though critics charge that many TV and magazine ads fail to do so.

Currently the FDA relies on a few dozen staffers to review hundreds of pharmaceutical ads, brochures and presentations voluntarily submitted by companies or reported to the agency by drug industry personnel.

The agency issues warning letters to companies using misleading materials, but because of the volume of submissions those letters often aren't sent until months after the ad is released -- and in some cases after the ad is no longer in circulation.

As part of its new program FDA will offer doctors training at medical conferences to help spot misleading ads. They can report advertising violations anonymously by e-mailing badad(at)fda.gov or calling 877-RX-DDMAC.

"The Bad Ad Program will help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency," said Thomas Abrams, director of FDA's drug advertising division.

The drug industry's lobbying group said in a statement it supported the effort as "another step to help educate -- and receive feedback from -- health care providers about prescription drug advertising and promotion."

The lobbying group, Pharmaceutical Research and Manufacturers of America, represents most of the world's largest drugmakers, including Pfizer, Merck & Co. and GlaxoSmithKline.

Drugmakers spend about $20 billion per year to promote their products in various mediums, ranging from medical journal ads and information booths at conferences to multimillion dollar TV campaigns.

About $4 billion of industry spending goes toward patient-targeted advertisements. Some drug industry critics charge TV drug advertisements encourage over-prescribing of medications by emphasizing the benefits and minimizing the risks.

The FDA is also conducting a 2,000-person study to determine if the relaxing, upbeat images featured in TV drug ads distract consumers from warnings about the drugs' risks.

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