Pharmaceutical Ads Often Don't Adhere to U.S. FDA Guidelines

Only 18.1 percent of advertisements fully adhere to FDA guidelines, over half do not quantify serious risks

THURSDAY, Aug. 25 (HealthDay News) -- Physician-targeting pharmaceutical advertisements have low rates of adherence to U.S. Food and Drug Administration (FDA) guidelines and provide inadequate information for safe prescribing, according to a study published online Aug. 17 in PLoS One.

Deborah Korenstein, M.D., from the Mount Sinai School of Medicine in New York City, and colleagues investigated adherence to FDA guidelines and the presence of content important for safe prescribing among print advertisements in biomedical journals directed at physicians. Pharmaceutical advertisements from November 2008 in U.S. biomedical journals that published original research were cross-analyzed, and those for devices, over-the-counter medications, and disease awareness were excluded. FDA-guideline items were utilized to categorize advertisements as adherent, possibly non-adherent to at least one item, or non-adherent to at least one item. Content important for safe prescribing, including benefit quantification, risk information, and verifiable references, was assessed.

The investigators found that nine out of the 12 biomedical journals that met inclusion criteria contained 192 pharmaceutical advertisements for 82 products (median, two per product), which were included in the study. Six "teaser" advertisements containing only drug names were excluded. Among 83 full, unique advertisements evaluated, 15 (18.1 percent), 41 (49.4 percent), and 27 (32.5 percent) were fully adherent, non-adherent to at least one item, and possibly non-adherent due to incomplete information, respectively. Most advertisements had incomplete content important for safe prescribing, 57.8 percent did not quantify serious risks, 48.2 percent lacked verifiable references, and 28.9 percent failed to present efficacy quantification.

"Few physician-directed print pharmaceutical advertisements adhere to all FDA guidelines; over half fail to quantify serious risks," the authors write.

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