Study: Pharma journal ads are often not FDA-compliant

The journal PLoS One released a study yesterday on the adherence of pharmaceutical advertising in medical journals to the FDA’s guidelines. And the findings suggest that there may be a problem with the FDA’s regulations regarding drug advertising.

According to the study, less than 20% of the advertisements studied were completely compliant with FDA regulations. In addition, nearly half of the 89 advertisements from November 2008 issues of leading U.S. biomedical journals were non-compliant with at least one of the FDA’s descriptions of bias and a third were found to be possibly non-compliant due to incomplete information.

The full report on the study is available here.

I admit that 89 advertisements isn’t a very large sample size. And determining whether something is FDA-compliant or not is a somewhat subjective process. But these figures suggest that the FDA may need to make its regulations of drug advertising simpler and easier to understand.

The large pharmaceutical companies have staffs dedicated to ensuring compliance with the regulations put forth and enforced by DDMAC, the FDA sub-agency that governs this area. Even the smaller companies take great care to stay in compliance. They thoroughly vet all advertising and other promotional materials. Then they vet them again, and even more times still, before they go out in the public domain. With fines of hundreds of thousands, if not millions, of dollars on the line, you don’t want to mess around with this.

Yet in spite of all that, a sizable majority of ads appear to be non-compliant. And this makes me wonder if the FDA should make its regulations clearer and more concise. I’m all for the FDA requiring drug ads to be responsible, accurate, truthful and fair and balanced. But all the regulations in the world do no good if companies can’t comply with them.

I believe that content should have what I call “the 4 Cs:” it should be clear, compelling, complete and concise. No one expects government regulations to be compelling (that’s not what regulation is for after all!). But it would only help drug manufacturers and marketers if those regulations were clear, complete and concise. Regulate what needs to be regulated, but make the regulations as clear and simple as possible.


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