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Previous Volume 356:1700-1702 April 26, 2007 Number 17 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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Every 5 or 10 years, Congress enacts major legislation addressing pressing issues at the Food and Drug Administration (FDA). This year, the biggest reforms since at least 1997 are expected. A decade ago, reform was motivated by the perception that the agency wasn't getting new medicines to patients as efficiently as possible. Today, a leading concern is that it isn't protecting the public from drugs' risks as effectively as it might.

A key incident in raising such concern was the 2004 withdrawal by Merck of rofecoxib (Vioxx) because of an apparent increased risk of serious cardiovascular events. The withdrawal came . . . [Full Text of this Article]

Source Information

Dr. McClellan, who was commissioner of the FDA from November 2002 to March 2004, is a visiting senior fellow at the AEI–Brookings Joint Center for Regulatory Studies, Washington, DC, and is on leave as an associate professor of economics and medicine at Stanford University, Stanford, CA.

An interview with Dr. McClellan and Dr. Jerry Avorn can be heard at www.nejm.org.

This article (10.1056/NEJMp078057) was published at www.nejm.org on April 13, 2007.

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