Food and Drug Administration: Approval and Oversight of the Drug Mifeprex Metadata
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Title
- Main Title Food and Drug Administration: Approval and Oversight of the Drug Mifeprex
Creator
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Author: United States. Government Accountability Office.Creator Type: Organization
Publisher
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Name: United States. Government Accountability Office.Place of Publication: Washington D.C.
Date
- Creation: 2008-08-07
Language
- English
Description
- Content Description: A letter report issued by the Government Accountability Office with an abstract that begins "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."
Subject
- Library of Congress Subject Headings: Government accountability -- United States.
- Keyword: health care
- Keyword: justice and law enforcement
- Keyword: food and drug administration
- Keyword: letter report
Coverage
- Place Name: United States
Collection
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Name: Government Accountability Office ReportsCode: GAORT
Institution
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Name: UNT Libraries Government Documents DepartmentCode: UNTGD
Rights
- Rights License: pd
Resource Type
- Report
Format
- Text
Identifier
- Report No.: GAO-08-751
- Accession or Local Control No: 279440
- URL: http://gao.gov/products/GAO-08-751
- Archival Resource Key: ark:/67531/metadc297349