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Medical News & Perspectives
March 9, 2011

FDA Takes Slow Road Toward Withdrawal of Drug Approved With Fast-Track Process

JAMA. 2011;305(10):982-984. doi:10.1001/jama.2011.269

The US Food and Drug Administration (FDA) is apparently continuing to slow its withdrawal procedure for a drug that was granted access to the market through the agency's accelerated approval process.

At issue is midodrine hydrochloride, which received accelerated approval in 1996 for the treatment of symptomatic orthostatic hypotension. The approval was based on studies showing an improvement in the surrogate end point of 1-minute standing systolic blood pressure—a marker considered likely to correspond to clinical benefits, chiefly relief of symptoms and improved ability to perform activities of daily living. In granting accelerated approval, the FDA expects the manufacturer to conduct postmarket studies of clinical benefits and to determine adverse events.