S.3939 - RU-486 Patient Health and Safety Protection Act109th Congress (2005-2006)
Summary: S.3939 — 109th Congress (2005-2006)
Introduced in Senate (09/26/2006)
RU-486 Patient Health and Safety Protection Act - Requires the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to modify the conditions of approval of the new drug application for mifepristone (commonly referred to as RU-486, marketed as Mifeprex) to establish the additional restriction that the drug may not be prescribed or administered by any person other than a licensed physician who: (1) is qualified to personally handle complications resulting from an incomplete abortion or ectopic pregnancy; (2) has been trained to perform surgical abortions and has met all current applicable legal requirements to perform such abortions; (3) is qualified for ultrasound dating of pregnancy and detecting of ectopic pregnancy; (4) has completed a program regarding the prescribing of such drug that uses a curriculum approved by the Secretary; (5) has admitting privileges at a hospital to which the physician can travel in one hour or less; and (6) has been trained to recognize and treat afebrile infections. Requires the Secretary to establish guidelines for the review and approval of such curriculum and for such training.
Directs the Secretary to require that information provided to patients in connection with the prescription of the drug include additional strongly worded warnings: (1) regarding the nature of life-threatening afebrile infections and instructions on how to recognize such infections; and (2) against all possible deviations from FDA-approved methods of administration.
Prohibits a physician from deviating from FDA-approved methods of administration of such a drug.