Drug Ads Skirt FDA Regulations

Aug. 22, 2011— -- Most advertisements for drugs are out of bounds when it comes to complying with U.S. Food and Drug Administration regulations on advertising to doctors, researchers found.

During a one-month period, about half of ads missed the mark on at least one rule, and about a third were "possibly" non-adherent due to missing information, according to Dr. Deborah Korenstein of Mount Sinai School of Medicine in New York and colleagues.

Additionally, more than half failed to quantify serious risks, they reported online in the journal PLoS One.

The pharmaceutical industry currently enjoys a $58 billion marketing budget, while the FDA's division of drug marketing and advertising has significantly less -- just $9 million -- and thus can't review every ad that gets published.

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In an effort to augment its sparse budget, the agency has recently implemented the "Bad Ad" program, in which it asks physicians to report non-adherent or misleading ads. The FDA's guidelines, however, are subjective and challenging to enforce, and they don't emphasize transparency or include basic information relevant to prescribing, the researchers said.

In order to assess "bad ads" via the current criteria, the researchers searched the November 2008 issues of nine journals for drug ads, including Annals of Internal Medicine, Archives of General Psychiatry, Blood,Circulation, Hepatology, JAMA, Journal of the American College of Cardiology, Journal of Clinical Oncology, and the New England Journal of Medicine.

There were a total of 193 ads, with 89 unique ads for 82 products. After cutting six ads that were just "teasers," the total sample included 83 ads.

Overall, just 18.1 percent of the ads adhered to all FDA guidelines, Korenstein and colleagues found.

About half (49.4 percent) failed to comply with at least one FDA-mandated item, and 32.5 percent were possibly non-adherent due to incomplete information.

The most common reasons for being non-adherent were misused references to the literature and using graphics in a way that are misleading. Ads were often "possibly" non-adherent because they didn't citereferences or overrepresented the experience with the drug.