**GAO-08-751**                      Published: Aug 07, 2008. Publicly Released: Aug 18, 2008.                  

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## Highlights

In September 2000, the Food and Drug Administration (FDA), part of the Department of Health and Human Services (HHS), approved the drug Mifeprex for use in terminating early term pregnancy. FDA approved the drug under a provision of its Subpart H regulations, allowing it to restrict the drug's distribution to assure its safe use. Critics have questioned aspects of the Mifeprex approval process, including the reliance on historically-controlled clinical trials that compare a drug's effects on a condition to the known course of the condition rather than to another drug or placebo. Critics argued that Mifeprex does not fit within the scope of Subpart H, which applies to drugs that treat serious or life-threatening illnesses. Concerns have also been raised about FDA's oversight of the drug since approval, including the agency's response to deaths in U.S. women who had taken the drug. In this report GAO (1) describes FDA's approval of Mifeprex, including the evidence considered and the restrictions placed on its distribution; (2) compares the Mifeprex approval process to the approval processes for other Subpart H restricted drugs; and (3) compares FDA's postmarket oversight of Mifeprex to its oversight of other Subpart H restricted drugs. GAO reviewed FDA regulations, policies, and records pertaining to its approval and oversight of Mifeprex and the eight other Subpart H restricted drugs. In addition, GAO interviewed FDA officials and external stakeholders.

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## Topics

Health Care

AbortionsConsumer protectionData collectionDrug approvalsSubstance abuse treatmentEvaluation criteriaFederal regulationsFood and drug legislationPharmaceutical industryPharmacological researchPregnancyPrescription drugsProduct safetyRegulatory agenciesReporting requirementsRisk assessmentRisk managementSafety regulationTrialsWomenDrug developmentPolicies and procedures