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Capitol Health Call
March 8, 2016

FDA Fails to Adequately Track Safety of Expedited Drugs

JAMA. 2016;315(10):970. doi:10.1001/jama.2016.1783

According to a recent Government Accountability Office (GAO) report, the Food and Drug Administration (FDA) lacks complete, timely, accurate, and easily accessible postmarketing data to track potential safety issues of expedited drugs (http://1.usa.gov/1n3CDWs).

About a quarter of the drug applications approved between October 1, 2006, and December 31, 2014, used at least 1 of the FDA’s 4 expedited programs, the GAO report noted. Some applications used 2 or more programs, and 2 oncology drug applications used all 4: accelerated approval, breakthrough therapy designation, fast-track designation, and priority review. Oncology drugs represented about 1 in 5 expedited applications.

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