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The FDA and RU-486: Lowering the Standard for Women's Health
House Committee on Government Reform Subcommittee on Criminal Justice, Drug Policy, and Human Resources
House Committee on Government Reform
Subcommittee on Criminal Justice, Drug Policy, and Human Resources
Abstract
The Subcommittee on Criminal Justice, Drug Policy and Human Resources of the House Committee on Government Reform investigated the FDA's handling of RU486, focusing on its approval process, failures in ensuring proper dispensation, associated health issues, and evidence linking the drug to fatal infections. The report provides background on RU486, discusses FDA's alleged disregard for regulations during approval, and examines safety data gathered post-approval. It ultimately considers options for withdrawing the drug from the market due to significant risks to women's health.
Date
2006-10-01
Document Type
House Majority Staff Report
Serial Number
Document Length
40 pages
Congress
109
Relation
DOI
Keywords
Staff Reports
PAP Major Code
3: Health
PAP Minor Code
321: Regulation of Drug Industry, Medical Devices, and Clinical Labs
Related Hearings
House Committee on Small Business, Subcommittee on Regulation, Business Opportunities, and Energy, hearing on "RU 486: The Import Ban and Its Effect on Medical Research," 101st Cong., H.Hrg. 101-85, (1990, November 19)
House Committee on Small Business, Subcommittee on Regulation, Business Opportunities, and Energy, hearing on "The Safety and Effectiveness of the Abortifacient RU486 in Foreign Markets: Opportunities and Obstacles to U.S. Commercialization," 102nd Cong., H.Hrg. 102-56, (1991, December 5)
House Committee on Government Reform, Subcommittee on Criminal Justice, Drug Policy, and Human Resources, hearing on "RU-486: Demonstrating a Low Standard for Women\342\200\231s Health?" 109th Cong., H.Hrg. 109-202, (2006, May 17)
House Committee on Small Business, Subcommittee on Regulation, Business Opportunities, and Energy, hearing on "The Safety and Effectiveness of the Abortifacient RU486 in Foreign Markets: Opportunities and Obstacles to U.S. Commercialization," 102nd Cong., H.Hrg. 102-56, (1991, December 5)
House Committee on Government Reform, Subcommittee on Criminal Justice, Drug Policy, and Human Resources, hearing on "RU-486: Demonstrating a Low Standard for Women\342\200\231s Health?" 109th Cong., H.Hrg. 109-202, (2006, May 17)