Drug Ads Fail to Comply With FDA Rules

Most pharmaceutical drug ads might not go over well with the federal agency that regulates America’s medications and mandates how such ads are presented, according to a new study published online in the journal PLoS One.

“Bad Ad” program, noted MMM.

In November 2008, 192 ads were viewed. Researchers only counted those “unique” ads for products, eliminating 103 duplicates and 6 so-called “teaser” ads that mentioned a drug, but provided no additional information, said MMM. The final sample was comprised of 83 unique ads, all found in key U.S. biomedical journals, noted MMM.

According to the team’s hypotheses, about 15 ads—18 percent—complied with every FDA guideline, said MMM. A large 49 percent—41 ads—were out of compliance with at least one FDA-described bias and 27 ads—33 percent—were potentially nonadherant because of missing information, MMM said. Nearly 60 percent of the ads did not “quantify serious risks needed for safe prescribing of the medications, including death,” according to the researchers, wrote MMM. The authors did point out that assessing compliance with FDA rules can be subjective; however, the study revealed not only nonadherance to the guidelines but inconsistency with the regulator’s standards, which were last updated in 2001, said MMM.

While the regs discuss creating a balance safety-efficacy balance, there is not much guidance on how to present “useful and accurate” information, said MMM, according to the team. “An advertisement containing no specific efficacy claim, no quantification of drug safety, and no verifiable references would adhere fully to FDA guidelines, despite presenting no practical information for clinicians,” the team wrote, reported MMM. In response, the FDA had physicians review the ads as part of its “Bad Ad” program.

Misleading drug ads have long been an issue. Recently, we wrote that the FDA sent additional letters to drug makers regarding concerns it has with some drug marketing pieces including about an ad for a GlaxoSmithKline PLC cancer drug; a Website for a bladder treatment Glaxo co-promotes, which the agency described as “false or misleading”; and a consumer email from Novartis AG concerning pain gel Voltaren. In another FDA letter, the agency said a Website for the drug Vesicare, co-promoted by GlaxoSmithKline and Astellas Pharma Inc., provided unproven overstatements abut the drug’s efficacy; another FDA letter about the site stated that sufficient information to confirm the ads claims was not supplied.

Other pharmaceutical firms were warned by the FDA about misleading promotions: Gilead Sciences about its direct-to-consumer (DTC) print ads for Truvada, Gilead’s HIV medication, pointing to a “multiple-page ad” that suggested, Truvada is better that demonstrated; to Biogen over its Webcast promoting Tysabri, a multiple sclerosis treatment that was described as false or misleading and omitted the drug’s approved indication; and to Bayer Healthcare about revising marketing materials for Yaz and Yasmin to reflect important safety information and accurate FDA-approved conditions for treatment.

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