PlainBillCongress, translated.Legislation. Context. Public interest.Read twice and referred to the Committee on Labor and Human Resources.
Congressional Research Service
Version 00 · Introduced in Senate · Jan 27, 1993
Antiprogestin Testing Act of 1993 - Directs the Commissioner of Food and Drugs to collect: (1) information concerning the drug RU-486, including samples and specimens, required to be submitted by an applicant for approval of a new drug; and (2) such information regarding use of the drug as an abortifacient or contraceptive and for the treatment of cancer, brain tumors, Cushings syndrome, or other serious or life-threatening diseases. Requires the Commissioner to: (1) consider such information to be an application submitted by the manufacturer of the drug for its approval for each of such uses; and (2) review such information and issue an order approving or refusing to approve the application with respect to each such use. Directs the Commissioner to: (1) notify the Director of the National Institutes of Health (NIH) if the Commissioner issues an order refusing to approve the application because of the lack of adequate tests in the investigation of the drug, sufficient information, or substantial evidence; (2) submit to the Director all information relevant to the decision to issue such order; and (3) report to specified congressional committees concerning any such order. Requires the Director, if the Commissioner issues an order refusing to approve the application, to expeditiously conduct or support research (including clinical trials) on RU-486 in order to conduct tests that were not included in the investigation or to develop information or evidence that was not submitted with the application. Makes any such research subject to provisions of the Public Health Service Act concerning institutional review boards and peer review. Requires the Director to submit the results of the research to the Commissioner who shall consider the results (along with the information collected) to be information submitted by the drug manufacturer, review the drug application, and issue an order approving or refusing to approve it. Sets forth reporting requirements. Specifies that if the Commissioner issues an order approving an application with respect to such drug for any of such uses, any person who introduces the drug into interstate commerce or delivers the drug for such introduction shall reimburse the Food and Drug Administration and NIH for specified costs.
People & committees
Sen. Wellstone, Paul D. [D-MN] · D–MN
Legislative record
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Read twice and referred to the Committee on Labor and Human Resources.
Sponsor introductory remarks on measure. (CR S776)
Introduced in Senate
Primary sources
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Source last updated: Aug 26, 2025. Consult Congress.gov for the current record.
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