December 19, 2006
FDA issuing fewer drug ad warning letters: GAO report
The FDA is issuing fewer citations to drug companies for false and misleading advertising and taking longer to do it, according to a report issued by Congress’ investigational arm, the Government Accountability Office (GAO).
From 2002 through 2005, it took the FDA an average of four months to draft, approve and send warning letters and other correspondence to companies in violation of the FDA’s advertising rules, the report said. But between 1997 and 2001, before FDA lawyers began reviewing the letters as policy, it took two weeks on average to issue the letters.
The number of letters sent to drug makers by the FDA fell off by about half between the two time periods, the report said.
The GAO report also concluded that the FDA lacks an effective way to screen, review and track the growing number of more than 10,000 ads and Web sites called to its attention each year.
The Health and Human Services Department (HHS), the FDA’s parent agency, acknowledged to the GAO that the FDA’s six reviewers can’t scrutinize everything, so they focus on ads with the greatest potential to affect public health.
HHS said the lengthy legal reviews give the FDA more teeth because the letters that are sent rest on a more solid legal foundation. “As a result, companies take our letters more seriously and quickly react to the problems identified therein,” HHS said, in written comments to the GAO.
Coalition for Healthcare Communications Executive Director John Kamp called the GAO's criticism of the Division of Drug Marketing, Advertising and Communications (DDMAC) for issuing fewer warning letters “silly.”
“DDMAC has issued virtually no DTC warning letters since 2005 largely because of adherence to PhRMA's self regulatory principles. Let's praise the achievement, not damn it,” Kamp said. “Better government oversight doesn’t necessarily lead to spending more money and adding more staff. We need to shorten the regulatory review times, but it is also time for FDA to reform the advertising review process to ensure that it is objective, predictable and social science based.”