TortsProf Blog

Editor: Christopher J. Robinette
Widener Commonwealth Law School

Tuesday, January 27, 2009

GAO Issues Report Critical of FDA

Last week, the Government Accountability Office issued a report (large pdf) identifying the FDA as a "high-risk area[]needing broad-based transformation to address major economy, efficiency, or effectiveness challenges."  The summary notes:

The second new area is protecting public health through enhanced oversight of medical products. Concerns have been expressed about FDA's ongoing ability to fulfill its mission of ensuring the safety and efficacy of drugs, biologics, and medical devices. GAO's work examining a variety of issues at FDA echoes the conclusions reached by others that the agency is facing significant challenges that compromise its ability to protect Americans from unsafe and ineffective products. FDA needs to, among other things, improve the data it uses to manage the foreign drug inspection program, conduct more inspections of foreign establishments, systematically prioritize and track promotional materials for review, and adopt management tools to ensure that drug sponsors comply with regulations on the presentation of clinical trial results.      

(Via Mass Tort Defense)


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