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Capitol Health Call
July 13, 2005

Accelerated Approval Abuse

JAMA. 2005;294(2):171. doi:10.1001/jama.294.2.171-b

A staff report claiming abuses of the “accelerated approval” process by pharmaceutical manufacturers was issued June 1 by Rep Edward J. Markey (D, Mass), a senior member of the House Energy and Commerce Committee (http://www.house.gov/markey/Issues/iss_health_rep050601.pdf).

The report claims the majority of manufacturers that benefited from the Food and Drug Administration’s (FDA’s) accelerated approval process—designed to expedite drugs for patients with life-threatening illnesses—have not conducted timely postmarketing studies as required by law. Only 49 of the 91 postmarketing studies required by the FDA have been completed; half of the other 42 studies have not even started, the report said.