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Commentary |

How the US Drug Safety System Should Be Changed

Brian L. Strom, MD, MPH
JAMA. 2006;295(17):2072-2075. doi:10.1001/jama.295.17.2072.
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Reading a recent newspaper might remind one of the above quote. One of the questions the nation is currently confronted with is what should be done to address the safety of drugs. In this Commentary, the current system of drug safety monitoring will be described and the limitations of the current system will be highlighted. A potential solution will then be proposed that will require legislation to implement.

Corresponding Author: Brian L. Strom, MD, MPH, Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, 824 Blockley Hall, 423 Guardian Dr, Philadelphia, PA 19104-6021 (bstrom@cceb.med.upenn.edu).

Financial Disclosures: Dr Strom receives funding from the National Institutes of Health, Agency for Healthcare Research and Quality (including CERT funding, DEcIDE [Developing Evidence to Inform Decisions about Effectiveness] funding, and patient safety funding), has received grants and served as a consultant to most of the major pharmaceutical companies, and is a US Food and Drug Administration (FDA) Special Government Employee for serving on FDA advisory committees. He has served as a consultant to the Joint Commission on Prescription Drug Use, assisting in drafting its report. There was no funding support for the work presented in this article.

Previous Presentation: Presented as an invited talk at the Institute of Medicine Annual Meeting, October 23-24, 2005, Washington, DC.

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Figure. Alternative Models for Studying Drug Safety
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Top row, historical approach; middle row, where the current system is evolving toward now; and bottom row, proposed approach. Phase 1 indicates dose escalation, usually in healthy study participants; phase 2, dose ranging (usually first time in patients); phase 3, pivotal trials for registration; phase 4, postmarketing (not always required).

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