August 18th, 2011

Majority of pharma journal ads not FDA compliant, Mount Sinai study finds

Medical Marketing & Media

Researchers at the Mount Sinai School of Medicine have conducted an analysis of 83 unique professional print ads in biomedical journals and found that a mere 18% of these ads were compliant with FDA guidelines, and more than half of the ads failed to illuminate on serious risks associated with the medications, including death.

Of the total number of ads surveyed – all of which were found in leading US-based medical journals from just one month, in November 2008 – 15 ads (18%) were found to be in compliance with all FDA guidelines, 41 ads (49%) were found to be non-compliant with at least one form of FDA-described bias, and 27 ads (33%) were found to be “possibly non-adherent due to incomplete information,” according to a release.

Dr. Deborah Korenstein, lead author of the study and associate professor or medicine at Mount Sinai School of Medicine, maintains that this examination of journal ads was the first of its kind in nearly 20 years, and that results bring to light the inconsistencies in the current system FDA has in place. This is especially due to the fact that journal advertising has time and again been found to be the most profitable form of drug marketing, says Korenstein, with an approximate ROI of five dollars for every single dollar spent.

“The limited resources of the FDA’s Division of Drug Marketing and Advertising are a major barrier to successful regulation of the pharmaceutical industry’s multi-billion dollar marketing budget,” says Dr. Korenstein in a release. “We are hopeful that an update in FDA regulations, with increased emphasis on the transparent presentation of basic safety and efficacy information, might improve the quality of information provided in physician-directed pharmaceutical advertisements.”

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