GAO report: FDA still grapples with drug safety monitoring problems

Share this content:

A Senate committee chairman is calling for "big changes" at the Food and Drug Administration following a report's findings that the agency continues to have problems monitoring drug safety.

The Government Accountability Office report recommended a better system of tracking post-market safety issues. It also suggested that Congress give the FDA greater authority to require companies to conduct post-marketing studies.

Senate Finance Committee Chairman Charles E. Grassley (R-IA) and Rep. Joe Barton (R-TX), chairman of the House Energy and Commerce Committee, requested the report, which was released this week. The two have held hearings pertaining to the agency's handling of the withdrawal of the drug Vioxx.

Grassley has introduced a bill that would establish an independent drug safety office and impose fines for failure to conduct post-marketing studies. The GAO report identifies the kind of problems his staff has been looking into for the last two years, he said.

The report is available at http://www.gao.gov/new.items/d06402.pdf.