FDA Approval, Oversight Of Mifeprex 'Consistent' With Other Drugs, GAO Report Says

Main Category: Abortion
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 20 Aug 2008 - 5:00 PST

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FDA's approval process and postmarket oversight of Danco Laboratories' medication abortion drug Mifeprex, also known as RU-486, were "consisten[t]" with how the agency handles other drugs with restricted distribution, according to a Government Accountability Office report released Tuesday, Bloomberg reports (Larkin, Bloomberg, 8/18). FDA in 2000 approved Mifeprex -- known generically as mifepristone -- to be taken for early termination of pregnancy (Daily Women's Health Policy Report, 2/22).

Three Republican lawmakers opposed to abortion rights -- Rep. Roscoe Bartlett (Md.) and Sens. Jim DeMint (S.C.) and Michael Enzi (Wyo.) -- asked GAO, the investigative arm of Congress, to review the drug's approval process and FDA has responded to reports of potential complications resulting from the drug's use. FDA in 2006 reported that Mifeprex did not cause the bacterial infections of six women who died after taking the drug. Danco has since revised its prescribing information on Mifeprex and warned doctors and consumers about potential safety issues, according to the GAO report (Bloomberg, 8/18).

According to The Hill, critics of FDA's actions in relation to Mifeprex have focused on three areas -- the level of clinical evidence on safety the agency required; the agency's use of an approval process for drugs used to treat serious or life-threatening conditions under "Subpart H"; and FDA's reaction to reports of potentially serious side effects. For the report, GAO compared the process used for Mifeprex with the process used for other drugs given expedited approval but for limited distribution through medical specialists under Subpart H. The report states that the "approval process for Mifeprex was generally consistent with the approval processes for other Subpart H restricted drugs," The Hill reports.

Bartlett, DeMint and Enzi's offices were unavailable for comment. All three lawmakers have sponsored bills that would ban use of the drug, but there is no Senate version of the bill currently pending before Congress. HHS offered only technical comments on the report, according to The Hill (Young, The Hill, 8/18).

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