GAO Report Says FDA Delays Enforcement on ‘Deceptive’ Prescription Drug Ads
Some pharmaceutical companies have "repeatedly disseminated misleading advertisements" for prescription drugs, and delays in enforcement of federal regulations against the ads have allowed millions of additional U.S. residents to view them, according to a General Accounting Office report released yesterday, the New York Times reports. The report, which used data from the pharmaceutical industry, attributed the problem to a Bush administration revision to a federal rule that sets the standard of accuracy for direct-to-consumer prescription drug ads. The report said that the revision, which has delayed the time required to issue a notice of violation from two weeks to 11 weeks to allow government attorneys to review the notices, has "adversely affected" the ability of the FDA to address "deceptive" prescription drug ads. Sen. Susan Collins (R-Maine), one of five lawmakers who requested the report, said, "It takes so long to get letters issued by the FDA that the advertising campaign for a drug may have run its course before the company receives a letter demanding corrective action." The report also found that the ads have led to a "significant increase" in prescription drug use and expenditures. According to the report, about 8.5 million U.S. residents each year ask for and receive prescriptions for specific treatments featured in ad campaigns. Collins said, "The evidence suggests that consumers are paying a lot of attention to these ads, so it's imperative that they be accurate. If the increase in utilization is based on false claims, that's very troubling." In response to the report, HHS officials said that the FDA should issue enforcement letters "more quickly" but added that the letters must undergo a "rigorous" legal review because "the FDA cannot afford to be considered a paper tiger," the Times reports.
The report also found that pharmaceutical companies last year spent less on ads than on research and development, although ad expenditures increased at a "far greater rate," the Times reports. Some consumer advocates and Democratic lawmakers have said that the pharmaceutical industry spends more on ads than on research and development. According to the report, pharmaceutical companies last year spent $30.3 billion for research and development, compared to $19.1 billion for "all promotional activities," which included $2.7 billion for direct-to-consumer ads (Pear, New York Times, 12/4).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.