Protecting the Health of the Public: Institute of Medicine Recommendations on Drug Safety

iom.gif  The following perspective was just published free online in the New England Journal of Medicine:

Psaty BM, Burke SP. Protecting the Health of the Public: Institute of Medicine Recommendations on Drug Safety. New Engl J Med October 9 2006. [will appear in the October 26 print issue] 

Excerpt:
Soon after rofecoxib had been withdrawn from the market in September 2004, hearings of the
Senate Finance Committee and editorials in the lay and medical press raised serious questions about drug safety in the United States. In response, the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) asked the Institute of Medicine (IOM) to assess the U.S. drug-safety system. The IOM assembled a diverse panel of experts without ostensible bias or conflict of interest, none of whom were pharmaceutical industry employees. The committee, on which we served, reviewed published literature, held open meetings, and received comments from the pharmaceutical industry, the FDA, and nonprofit groups. In September 2006, the IOM released the committee’s findings and recommendations [The Future of Drug Safety].

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