New England Journal of Medicine recently published a paper looking at “A Decade of Direct-to-Consumer Advertising of Prescription Drugs”, where the study authors looked at pharma company spending on DTC advertising and physician promotion in the past 10 years (1996-2006). The authors also looked at the FDA regulation of drug advertising during this time. While drug companies’ promotional spending went from $11.4 billion (1996) to $29.9 billion (2005) where DTC ad expenditures grew by 330%, this made up “only” 14% of the almost $30 billion in drug companies’ promotional spend.
On the other hand, FDA’s warning letters fell from 142 in 1997 to 21 in 2006. The authors speculate this could either be due to drug companies becoming better behaved and playing by the rules, or due to the FDA being too short-staffed to follow up on all violative behaviors. I’m skeptical whether this reduction in FDA warning letters is mostly due to staff shortage at the FDA given how steep this drop was (142 to 21 per year); while I’d like to think that drug companies are finally being “scared straight” by the various scandals and class action lawsuits in the recent years, I’m also not so much of a pollyanna to believe that no violative behaviors are being produced. Still, it looks like DTC is here to stay, as much as many doctors loathe it with a passion of a thousand suns.
Full Article is currently available online.
A Decade of Direct-to-Consumer Advertising of Prescription Drugs
Julie M. Donohue, Ph.D., Marisa Cevasco, B.A., and Meredith B. Rosenthal, Ph.D.
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.