How the US Drug Safety System Should Be Changed

doi:10.1001/jama.295.17.2072

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Vol. 295 No. 17, May 3, 2006

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How the US Drug Safety System Should Be Changed

Brian L. Strom, MD, MPH

JAMA. 2006;295:2072-2075.

Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

If the whole materia medica, as now used, could be sunk to thebottom of the sea, it would be all the better for mankind, andall the worse for the fishes.—Oliver Wendell Holmes, Sr¹

Reading a recent newspaper might remind one of the above quote.One of the questions the nation is currently confronted withis what should be done to address the safety of drugs. In thisCommentary, the current system of drug safety monitoring willbe described and the limitations of the current system willbe highlighted. A potential solution will then be proposed thatwill require legislation to implement.

Current System of Drug Safety Monitoring

The current system of drug safety monitoring includes preclinicaltesting followed by 3 phases of clinical studies (Figure). Drugapproval is sometimes followed by postmarketing studies. Usually,only 500 to 3000 patients are studied before marketing. Therefore,by definition, . . . [Full Text of this Article]

Author Affiliation: Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia.

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