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October 12, 2011

Improving the Food and Drug Administration's Mandate to Ensure Postmarketing Drug Safety

Author Affiliations

Author Affiliations: Section of General Internal Medicine, Department of Medicine, University of Chicago Hospitals, Chicago, Illinois (Drs Qato and Alexander); Chicago Core on Biomarkers in Population-based Research, NORC at the University of Chicago Center on Demography and Economics of Aging, Chicago (Dr Qato); Center for Health and the Social Sciences (Dr Alexander) and MacLean Center for Clinical Medical Ethics (Dr Alexander), University of Chicago, Chicago; and Department of Pharmacy Practice, University of Illinois at Chicago School of Pharmacy, Chicago (Dr Alexander).

JAMA. 2011;306(14):1595-1596. doi:10.1001/jama.2011.1457

Efforts by the Food and Drug Administration (FDA) to ensure the safety of prescription medicines historically have focused on the requirements for therapies to gain market approval. However, many safety risks are discovered only after a medication reaches the market.1 During the past decade, reports by the Institute of Medicine2 and calls from policy experts have provided momentum to improve the US drug regulation system. One major step in this direction was achieved in 2007 when Congress passed the FDA Amendments Act (FDAAA).3 Although the FDA has frequently sought to avoid a focus on postmarketing regulation by emphasizing that it “does not regulate the practice of medicine,” the FDAAA language suggests increasing involvement of the agency in shaping clinical practice to ensure safe medication use.

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