A Government Accountability Office (GAO) report, released Monday, found that mifepristone (also known as RU-486) has not received special treatment by US regulators, as some critics have suspected. Mifepristone is sold under the trade name Mifeprex and is a nonsurgical form of early abortion.
Senator Michael Enzi (R-WY), Senator Jim DeMint (R-SC), and Representative Roscoe Bartlett (R-MD) requested a GAO review of the approval and monitoring of mifepristone by the Food and Drug Administration (FDA). A number of concerns provided justification for a review, including “reliance on data from historically controlled clinical trials”; Mifeprex’s classification as qualifying under Subpart H regulations, “which apply to drugs that are intended to treat a serious or life-threatening illness”; and concerns about monitoring including “efforts to ensure the sponsor’s compliance with conditions of approval as well as the actions the agency has taken in response to reported adverse events.”
The report found that “the approval process for Mifeprex was generally consistent with the approval processes for the other eight Subpart H restricted drugs” and that “FDA’s postmarket oversight of Mifeprex has been consistent with the agency’s postmarket oversight of the other Subpart H restricted drugs.” These conclusions result from detailed comparisons of the approval and monitoring of Mifeprex and other Subpart H drugs.