Food and Drug Administration surveillance of dermatology-related and nondermatology-related prescription drug advertising in the USA, 2000-2003.

BACKGROUND

Spending on advertising of prescription medicines in the U.S.A. is increasing by nearly a billion dollars yearly. The Food and Drug Administration (FDA) is legally mandated to regulate pharmaceutical advertising in the U.S.A. Prior studies have documented inaccuracies in pharmaceutical advertisements, in the U.S.A. and the rest of the world.

OBJECTIVES

To assess trends in FDA surveillance of dermatology-related prescription drug advertising, and to investigate pharmaceutical companies' responses to FDA regulatory actions.

METHODS

We analysed all FDA citations of prescription drug advertisements issued during 2000-2003, and responses from cited companies to our mailed requests for follow-up information.

RESULTS

Twenty-four dermatology-related drugs from 21 companies accounted for 30 (15.2%) of the 198 letters sent by the FDA; of these, 18 letters cited advertisements or promotions of these medications for dermatology-related uses. The most common violation cited overall was insufficient communication of risk (32.4% overall, 33.9% dermatology-related). Most FDA letters cited physician-targeted advertising (71.6% overall, 62.1% dermatology-related). The number of dermatology-related letters sent declined by 69.2% from 2000 (n=13) to 2003 (n=4), paralleling the 69.6% decline in the total number of letters sent (n=79 in 2000, n=24 in 2003). Compared with 2000, the FDA took longer to issue citation letters in 2003 for advertisements overall [hazard ratio (HR) 0.47, 95% confidence interval (CI) 0.27-0.72, P=0.001], although this trend was not present for dermatology-related advertisements (HR 1.12, 95% CI 0.39-3.29, P=0.83). Eight of the 16 companies (50%) that received requests from the authors for information replied. Seven of the eight (87.5%) reported complying with FDA requests to discontinue the cited advertisements, while one (12.5%) reported disagreeing with the citation and successfully clarifying the issue with the FDA.

CONCLUSIONS

Dermatology-related advertisements accounted for 15.2% of FDA citations of pharmaceutical advertisements between 2000 and 2003. Recent controversy over pharmaceutical advertising may lead to changes in pharmaceutical advertising practices and surveillance of pharmaceutical advertising in the U.S.A.