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February 23, 2011

Withdrawing FDA Approval of Midodrine After Marketing

JAMA. 2011;305(8):781-782. doi:10.1001/jama.2011.161

To the Editor: Drs Dhruva and Redberg1 urged the Food and Drug Administration (FDA) to remove midodrine from the market after it was granted accelerated approval but the manufacturer did not complete confirmatory trials. We doubt that their recommendations will force drug companies to adhere to postmarketing commitments in return for accelerated premarket approval. Failure to conduct the requisite studies to prove “a benefit in clinical outcomes,”1 or to withdraw a drug when no clinical benefit is found, should carry financial penalties. Moreover, the public, including health professionals, needs to know which companies that have received accelerated approval have violated the FDA's postmarketing requirements. If the FDA is receiving “powerful pressure from many sources”1 to ignore its own requirements, the public, including health professionals, needs to know the sources. Two of the citations used by Dhruva and Redberg indicated companies in violation of FDA rules and sources of pressure on the FDA,2,3 but their Commentary did not reveal them. In addition, any group or individual (including patients) that appeals to the FDA not to withdraw a drug should be required to provide empirical data on the proportion of patients benefiting from the drug.