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
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
Mitka M. Accelerated Approval Abuse. JAMA. 2005;294(2):171. doi:https://doi.org/10.1001/jama.294.2.171-b
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