Four out of five ads analyzed in a study of physician-directed pharmaceutical advertising would definitely not pass FDA muster, or might have trouble doing so, said researchers. Their findings may have implications for the FDA, DDMAC and the "Bad Ad" program.
The study was published online today in the journal PLoS One.
Out of 192 ads initially seen during one month, November 2008, researchers counted only the unique ads for products, eliminating duplicates (103) as well as teaser ads (6) that mentioned a drug name with no other information. The final sample contained 83 unique ads. All ads were found in leading US-based biomedical journals.
Researchers hypothesized that only 15 ads (18%) were in compliance with all FDA guidelines, 41 ads (49%) were 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.
More than half the ads (57.8%) failed to quantify serious risks needed for safe prescribing of the medications, including death, they said.
The authors acknowledged the subjectivity of assessing adherence with FDA rules; a 1990 study of physician-directed journal ads found a 92% non-adherence rate. But Dr. Deborah Korenstein, lead author, said the results, in addition to showing relatively high rates of non-adherence, also highlight inconsistencies in the current FDA standards.
Last updated in 2001, FDA advertising regs stress a balance between efficacy and safety information but do little to encourage presentation of "useful and accurate" information.
"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," she and colleagues wrote.
Perhaps there should be no expectation that journal ads "inform rational prescribing." Indeed, the medium has time and again been found to be the most profitable form of drug marketing, with an approximate ROI of five dollars for every single dollar spent, noted Korenstein, an associate professor of medicine at Mount Sinai School of Medicine.
The study could have important policy implications. The FDA recently enlisted doctors to review ads through its “Bad Ad” program, a move that showed the agency's desire to improve ad quality but which got off to a slow start.
"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,” Korenstein said 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.”