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Previous Volume 357:673-681 August 16, 2007 Number 7 Next

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ABSTRACT

Background Evidence suggests that direct-to-consumer advertising of prescription drugs increases pharmaceutical sales and both helps to avert underuse of medicines and leads to potential overuse. Concern about such advertising has increased recently owing to the withdrawal from the market of heavily advertised drugs found to carry serious risks. Moreover, the Food and Drug Administration (FDA) has been criticized for its weak enforcement of laws regulating such advertising.

Methods We examined industry-wide trends in spending by pharmaceutical companies on direct-to-consumer advertising and promotion to physicians during the past decade. We characterized the drugs for which such advertising is used and assessed the timing of advertising after a drug is introduced. Finally, we examined trends in the FDA's regulation of drug advertising.

Results Total spending on pharmaceutical promotion grew from $11.4 billion in 1996 to $29.9 billion in 2005. Although during that time spending on direct-to-consumer advertising increased by 330%, it made up only 14% of total promotional expenditures in 2005. Direct-to-consumer campaigns generally begin within a year after the approval of a product by the FDA. In the context of regulatory changes requiring legal review before issuing letters, the number of letters sent by the FDA to pharmaceutical manufacturers regarding violations of drug-advertising regulations fell from 142 in 1997 to only 21 in 2006.

Conclusions Spending on direct-to-consumer advertising has continued to increase in recent years in spite of the criticisms leveled against it. Our findings suggest that calls for a moratorium on such advertising for new drugs would represent a dramatic departure from current practices.

Source Information

From the Department of Health Policy and Management, University of Pittsburgh Graduate School of Public Health, Pittsburgh (J.M.D.); the Department of Health Policy and Management, Harvard School of Public Health, Boston (M.C., M.B.R.); and Vanderbilt School of Medicine, Nashville (M.C.).

Address reprint requests to Dr. Donohue at the Department of Health Policy and Management, University of Pittsburgh Graduate School of Public Health, Crabtree Hall A613, 130 DeSoto St., Pittsburgh, PA 15261, or at jdonohue{at}pitt.edu.

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