Blueprint for a Stronger Food and Drug Administration

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Abstract
Over the past 5 years, a series of recalls of high-profile prescription medications has aroused serious concern about the safety of the nation's drug supply. Faced with a crisis of confidence, the Food and Drug Administration (FDA) in 2004 called on the Institute of Medicine (IOM) of the National Academies to conduct a comprehensive review of the safety of prescription drugs. The IOM assembled a distinguished review committee, and after nearly a year and a half of deliberations, a draft of the committee report became public on September 21, 2006 (www.iom.edu/CMS/3793/26341/37329.aspx). The committee recommends a number of specific reforms that we believe should serve as a blueprint for a stronger system of drug regulation. The reforms are discussed by Psaty and Burke in this issue of the Journal.1

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