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Volume 352:1285-1287 March 31, 2005 Number 13
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Learning the Value of Drugs — Is Rofecoxib a Regulatory Success Story?
Rebecca S. Eisenberg, J.D.

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Controversy over recent revelations concerning the adverse cardiovascular effects of selective cyclooxygenase-2 (COX-2) inhibitors has generally been framed as a story of regulatory failure, in which the Food and Drug Administration (FDA) has failed in its mission to protect the public from unsafe products. But this simplistic understanding of the mission of the FDA seems to make failure all but inevitable, if the reliable observation of the risks and benefits of a drug requires rigorous long-term studies. Perhaps in an earlier era the goal of drug regulation was simply to protect the public from poisons.1 Today, drug regulation guides the . . . [Full Text of this Article]


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Ms. Eisenberg is a professor of law at the University of Michigan Law School, Ann Arbor.


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