FDA issuing fewer drug ad warning letters: GAO report

Share this article:
The FDA is issuing fewer citations to drug companies for false and misleading advertising and taking longer to do it, according to a report released today 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 effect 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.
Share this article:

Email Newsletters

More in News

BMS Q2 sales slip, Eliquis, Yervoy soar

BMS Q2 sales slip, Eliquis, Yervoy soar

The company attributed part of the Eliquis boost to the BMS-Pfizer DTC and education efforts.

Gilead, Merck HCV marketing battle may be on horizon

Gilead, Merck HCV marketing battle may be on ...

Disclosed in its earnings report yesterday, Gilead may have a card up its sleeve to counter Merck's experimental hep. C combo regimen.

Sales of Biogen MS pill pick up overseas

Sales of Biogen MS pill pick up overseas

Biogen Idec is seeing strong sales for blockbuster MS drug Tecfidera, especially overseas where it's beginning to catch fire this summer.