Healthy Skepticism Library item: 11403

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Publication type: Journal Article

Smith SW.
Sidelining Safety — The FDA's Inadequate Response to the IOM
NEJM 2007 Sep 6; 357:(10):960-963
http://content.nejm.org/cgi/content/full/357/10/960

Abstract:

Having been commissioned by the Food and Drug Administration (FDA) to evaluate the U.S. drug-safety system, the Institute of Medicine (IOM) published a report, The Future of Drug Safety, in September 2006 identifying weaknesses in the laws, regulations, resources, and practice of ensuring drug safety.1 Some of the IOM’s recommendations were directed toward Congress, which it believed should increase FDA funding and regulatory authority. Some outlined ways in which other federal agencies could work in partnership with the FDA for the public good. But most of the report outlined deficiencies that the FDA itself – or the Department of Health and Human Services (DHHS), to which it belongs – should correct…

Notes:

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