[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 3939 Introduced in Senate (IS)]


109th CONGRESS
  2d Session
                                S. 3939

 To require the Food and Drug Administration to establish restrictions 
 regarding the qualifications of physicians to prescribe the abortion 
                     drug commonly known as RU-486.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 26, 2006

 Mr. Vitter (for himself, Mr. Inhofe, Mr. Brownback, and Mr. Santorum) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To require the Food and Drug Administration to establish restrictions 
 regarding the qualifications of physicians to prescribe the abortion 
                     drug commonly known as RU-486.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``RU-486 Patient Health and Safety 
Protection Act''.

SEC. 2. ESTABLISHMENT OF RESTRICTIONS REGARDING PRESCRIBING OF CERTAIN 
              ABORTION DRUG.

    (a) In General.--With respect to the application that was submitted 
under section 505(b) of the Federal Food, Drug, and Cosmetic Act for 
the drug mifepristone (commonly referred to as RU-486, marketed as 
MIFEPREX), and that was approved on September 28, 2000, the Secretary 
of Health and Human Services, acting through the Commissioner of Food 
and Drugs, shall within 90 days of the date of enactment of this Act, 
modify the conditions of the approval of such drug to establish the 
additional restriction that the drug may not be prescribed or 
administered by any person other than a licensed physician who meets 
the following requirements:
            (1) The physician is qualified to personally handle 
        complications resulting from an incomplete abortion or ectopic 
        pregnancy.
            (2) The physician has been trained to perform surgical 
        abortions and has met all current applicable legal requirements 
        to perform such abortions.
            (3) The physician is qualified for ultrasound dating of 
        pregnancy and detecting of ectopic pregnancy.
            (4) The physician has completed a program regarding the 
        prescribing of such drug that uses a curriculum approved by the 
        Secretary in accordance with subsection (c)(1).
            (5) The physician has admitting privileges at a hospital to 
        which the physician can travel in one hour or less, determined 
        on the basis of starting at the principal medical office of the 
        physician and traveling to the hospital, using the 
        transportation means normally used by the physician to travel 
        to the hospital, and under the average conditions of travel for 
        the physician.
            (6) The physician has been trained to recognize and treat 
        afebrile infections, in accordance with guidelines established 
        under subsection (c)(2).
    (b) Informational Requirements.--With respect to information 
provided to patients in connection with the prescription of the drug 
referred to in subsection (a), the Secretary of Health and Human 
Services shall require that such patient information include--
            (1) an additional strongly worded warning (as determined by 
        the Secretary of Health and Human Services) regarding the 
        nature of life-threatening afebrile infections and instructions 
        on how to recognize afebrile infections, including the fact 
        that women taking RU-486 and an accompanying prostaglandin for 
        abortion have died from afebrile infections, hemmorage, heart 
        attack, and rupture of undetected ectopic pregnancies; and
            (2) an additional strongly worded warning (as determined by 
        the Secretary) against all possible deviations from the FDA-
        approved methods of administration, such as reduced dosage, 
        increased dosage, failure to return for supervised 
        administration on day 3, and vaginal self-administration of 
        misoprostol.
    (c) Guidelines.--
            (1) Curriculum.--The Secretary of Health and Human Services 
        shall establish guidelines for the review and approval of 
        curriculum to be used for purposes of subsection (a)(4).
            (2) Training.--The Secretary of Health and Human Services 
        shall establish guidelines for the training of physicians for 
        purposes of subsection (a)(6).
    (d) Limitation.--With respect to the administration of a drug 
referred to in subsection (a), a physician shall not deviate from the 
Food and Drug Administration approved methods of administration of such 
a drug.
                                 <all>