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November 17, 2010

Accelerated Approval and Possible Withdrawal of Midodrine

Author Affiliations

Author Affiliations: UCSF Department of Medicine, San Francisco, California. Dr Redberg is also Editor, Archives of Internal Medicine.

JAMA. 2010;304(19):2172-2173. doi:10.1001/jama.2010.1695

In 1992, the US Food and Drug Administration (FDA) introduced the accelerated approval process to allow earlier approval of drugs for serious or life-threatening illnesses on the basis of surrogate end points. This approval requires the drug's sponsor to agree to conduct postmarketing studies proving a benefit in clinical outcomes. Seventy-nine of the 90 drugs approved through this process through 2008 were for treatment of cancer, human immunodeficiency/AIDS, or inhalation anthrax.1 In 1996, midodrine hydrochloride, an α1-adrenergic agonist, was granted accelerated approval for treatment of symptomatic orthostatic hypotension with the guarantee that the drug's sponsor would complete postmarketing studies to demonstrate clinical benefit. On August 16, 2010, noting that these studies had not been conducted, the FDA proposed to withdraw the medication.2 This withdrawal would be a landmark step in protecting the public's health, as it is the agency's first attempt to remove a medication marketed under accelerated approval that had not completed confirmatory trials. However, professional organizations, health care professionals, and patients appealed to the FDA to reverse its decision, and it did so on September 10.3