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Capitol Health Call
May 9, 2012

Speeding Drug Approvals

JAMA. 2012;307(18):1904. doi:10.1001/jama.2012.4001

A bill introduced March 26 by 3 senators is intended to speed up the Food and Drug Administration's (FDA’s) new medication approval process. The Advancing Breakthrough Therapies for Patients Act of 2012 (S2236 [http://thomas.loc.gov]) is cosponsored by Sen Orrin Hatch (R, Utah), Sen Richard Burr (R, NC), and Sen Michael Bennet (D, Col).

The bill would amend the Food, Drug, and Cosmetic Act to require the FDA to facilitate the development and expedite the review of breakthrough drugs. These are defined as medications that are intended for a serious or life-threatening disease or condition and for which preliminary clinical evidence indicates that these medications may demonstrate substantial improvement over existing therapies.