The number of direct-to-consumer prescription drug advertisements reviewed by FDA decreased by about half between the 1997-2001 period and the 2002-2005 period, and the length of time taken to draft and approve warning letters increased, according to a report released on Thursday by the Government Accountability Office, the AP/Atlanta Journal-Constitution reports.
In the 2002-2005 period, FDA took an average of four months to draft and approve warning letters to pharmaceutical companies that had violated rules on DTC prescription drug ads, compared with an average of two weeks in the 1997-2001 period, the report found. In addition, the report found that FDA lacks an effective system to track and review the more than 10,000 DTC prescription drug ads and Web sites reported to the agency annually.
HHS said that FDA, which currently has six staff members to review DTC prescription drug ads, cannot review all of the ads and must focus on those with the most potential to affect public health. In addition, HHS said that the longer reviews of DTC prescription drug ads allow FDA to develop a stronger legal foundation for warning letters.
"As a result, companies take our letters more seriously and quickly react to the problems identified therein," HHS said in written comments to GAO.
Sen. Herb Kohl (D-Wis.) said, "If we are serious about protecting the health of consumers in our country, then we need an FDA capable of reviewing (direct-to-consumer) ads and taking swift action when necessary. This report tells us that we're nowhere close to that goal."
Kohl requested the report with Senate Majority Leader Bill Frist (R-Tenn.) and Sen. Chuck Grassley (R-Iowa) (Bridges, AP/Atlanta Journal-Constitution, 12/14).