January 22, 2009

Government Accountability Office's report to Congress declares the FDA is in dire need of improvement

In a report released to Congress today, the U.S. Government Accountability Office (GAO) said its ongoing investigation of the FDA confirmed widespread concerns about serious weaknesses within the FDA that compromise its ability to fulfill its mission of ensuring the safety and efficacy of drugs, medical devices, and biologics.  This latest blow comes on the heals of the FDA’s own Science Board issuing a report in 2007 finding that the FDA’s resources had not increased in proportion to the growing demands placed on it, thereby putting public health at risk.  Areas of particular concern to the GAO that were outlined in the 99-page report include whether the FDA has the ability to ensure the quality of medical products manufactured overseas since the agency conducts as little as 8% of foreign drug manufacturing establishments per year.  The GAO also identified problems with the data the FDA uses to analyze post-market approval drug safety, often relying on the voluntary agreement of drug sponsors to complete post-market studies.  Additionally, as advertising and promotions of prescription drugs have skyrocketed in recent years, the FDA’s oversight has been unable to keep up with the increased demand generated by the millions of dollars spent by drug manufacturers.  Finally, the GAO also pointed out its concern that as little as 1% of clinical trial sites are inspected for new drugs prior to the release to U.S. consumers, with recent estimates showing that the FDA only has around 200 inspectors to police around 350,000 testing sites.


Click here to view entire GAO report

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