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GAO report details problems at FDA

By admin
Created Apr 23 2006 - 8:01pm

An inquiry by Congressional researchers finds that the FDA approach to drug safety has changed little despite criticism from consumer advocates and prominent critics in medicine. The GAO looked at the agency's handling of safety issues and found little evidence that the agency has improved its oversight of drugs once they hit the market. The report concludes that the FDA should be given more power to compel drug companies to complete post-marketing studies. The authors also argue that Office of Drug Safety should be given independence from the Office of New Drugs.

The new report could "revive stalled new drug-safety legislation" writes The Wall Street Journal. The investigation was requested by Sen. Joe Barton (R-TX) and Sen. Charles Grassley (R-IA), in the wake of recent safety scandals including the 2004 withdrawal of Merck's painkiller Vioxx.

- read this article [1] from The Washington Post 


Source URL:
http://www.fiercehealthcare.com/story/gao-report-details-problems-at-fda/2006-04-24