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February 23, 2011

Withdrawing FDA Approval of Midodrine After Marketing—Reply

JAMA. 2011;305(8):781-782. doi:10.1001/jama.2011.162

In Reply: The call by Drs Holtzman and Starfield to impose financial penalties on companies that fail to adhere to their agreement to perform postmarketing trials is very reasonable. Midodrine generated more than $250 million in sales over a 13-year period,1 none of which was spent to conduct the clinical trials that the sponsor was bound to perform. Their suggestion to have sponsors literally pay for reneging on their obligations to the FDA and to patients taking the medication makes sense. In addition, drugs whose requisite studies are not completed should be withdrawn in a timely manner to prevent the companies from continuing to earn profits on unproven therapies. Fourteen years, and several warning letters from the FDA to midodrine's sponsors, is far too long.