Drug Ads Skirt FDA Regulations

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 cite references or overrepresented the experience with the drug.

"There was no single problem that was consistently identified for non-adherence," the researchers wrote.

They noted that there were differences in non-adherence by the product indication category. Non-adherence to at least one FDA item was seen in 60.5 percent of hematology/oncology products, in 52.9 percent of cardiovascular and diabetes products, and in 28.6 percent of psychiatric products.

Korenstein and colleagues also found the ads were incomplete in terms of safe prescribing information: 57.8 percent didn't quantify serious risks; 48.2 percent lacked verifiable references; and 28.9 percent failed to give adequate efficacy quantification.

"Advertisements do a poor job of conveying basic information necessary for safe prescribing, with the majority failing to quantify serious risks," they wrote.

Still, they noted that overall, "despite the high rates of FDA non-adherence, the mean number of biased features in each advertisement was low, and most advertisements we reviewed satisfied the majority of FDA guidelines."

However, they cautioned that FDA guidelines don't target ad features that are highly relevant for informing prescribers. For instance, they wrote, an ad with no specific efficacy claim, no quantification of drug safety, and no verifiable references would fully adhere to FDA guidelines.

Now that the FDA has stepped up its game with the "Bad Ad" program, Korenstein and colleagues said the agency needs to update and simplify its guidelines -- make them straightforward and objective, they said, and require ads to give clear risk quantification, information on absolute benefits, verifiable references, and describe the appropriate population for drug use.

The study was limited by its cross-sectional nature as it focused on ads published during only a single month. The subjectivity of the FDA guidelines, and the subjectivity of determining adherence were also limiting factors.