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Direct-to-Consumer Prescription Drug Advertising Up in U.S.

A study published in the August 16, 2007 issue of the New England Journal of Medicine, (NEJM) notes that in spite of increasing criticisms direct-to-consumer advertising of prescription drugs continues to increase in the US. The study starts off with some background information and states, "Evidence suggests that direct-to-consumer advertising of prescription drugs increases pharmaceutical sales and both helps to avert under-use of medicines and leads to potential overuse."

The results of this study showed that total spending on pharmaceutical promotion grew from $11.4 billion in 1996 to $29.9 billion in 2005. During that time spending by drug companies on direct-to-consumer advertising increased by 330%. The study noted that in most cases direct-to-consumer campaigns generally begin within a year after the approval of a product by the US Food and Drug Administration (FDA). Even with this tremendous increase in spending, the study noted that, "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."

The NEJM study was also reported on by several news outlets, however, most were not in the United States. One report in the US by HealthDay News on August 15, 2007 questions direct-to-consumer advertising of prescription drugs. Presently only the United States and New Zealand allow drug makers to advertise prescription medications directly to consumers.

Study author Julie M. Donohue, assistant professor of health policy and management at the University of Pittsburgh Graduate School of Public Health, states, "Direct-to-consumer advertising spending is increasing in terms of its share of total marketing budget, but it's still a smaller share relative to promotion aimed at influencing prescribers." Donohue continued, "It's been 10 years since the FDA clarified its policy with respect to broadcast advertising and unleashed direct-to-consumer advertising on television, which was new. We wanted to see, in the wake of the Vioxx withdrawal and an increased focus on the safety of drugs and a focus on drug costs in light of the implementation of the new Medicare drug benefit, what industry and the FDA were doing with respect to advertising."

An August 15, 2007 article in "The Canadian Press" on this study noted that such advertisements are currently not permitted in Canada but that there are legal challenges to allow this type of advertising. The Canadian article noted that earlier this year a report published by the U.S. Institute of Medicine recommended that the US Food and Drug Administration, bar drug companies from advertising prescription drugs in the first two years after they come to market. The reasoning is that during that 2 year period a drug will start to be broadly used and therefore rare side-effects not seen in clinical trials can become evident.

However, study author Donohue expresses skepticism that any change will take place in the conclusion of her study when she states, "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."