Thursday, August 25, 2011

Drug Ads for Doctors Fail FDA's Guidelines

Nearly half of advertisements directed at physicians fail to adhere to at least one FDA guideline governing content. That’s the finding of researchers at Mount Sinai School of Medicine, who recently performed a cross-sectional analysis of November 2008 pharmaceutical advertisements in top U.S.-based biomedical journals.

They found that these advertisements contained bias on a wide range of issues across content areas addressed by the FDA; there was no single problem that was consistently identified for guideline nonadherence. They also found that the ads do a poor job of conveying basic information necessary for safe prescribing, with the majority failing to quantify serious risks, more than one quarter failing to quantify benefits, and nearly half providing no verifiable references.

“Our study is the first in nearly 20 years to provide a systematic assessment of the adherence of U.S. advertisements to FDA guidance and provides context to inform the FDA's new 'bad ad' program,” said Deborah Korenstein, M.D., an associate professor of medicine at Mount Sinai, and her colleagues, in online PloS One August 17. “Physicians should ensure that their prescribing is informed by the clinical literature and not by marketing materials."

Read more about the FDA's "bad ad" program in Psychiatric News at

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