[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5385 Introduced in House (IH)]







106th CONGRESS
  2d Session
                                H. R. 5385

 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 HOUSE OF REPRESENTATIVES

                            October 4, 2000

 Mr. Coburn (for himself, Mr. Armey, Mr. DeLay, Mr. Watts of Oklahoma, 
  Mr. Smith of New Jersey, Mr. Oberstar, Mr. Stupak, Mrs. Myrick, Mr. 
    Rahall, Mr. Aderholt, Mr. Baker, Mr. Shimkus, Mrs. Emerson, Mr. 
    Schaffer, Mr. DeMint, Mr. Doolittle, Mr. Wamp, Mr. Istook, Mr. 
  Hilleary, Mr. Burr of North Carolina, Mr. Tancredo, Mr. Vitter, Mr. 
 Pickering, Mr. English, Mr. Hayes, Mr. Peterson of Pennsylvania, Mr. 
 Barr of Georgia, Mr. Pitts, Mr. Dickey, Mr. Hostettler, Mr. Hoekstra, 
Mr. Largent, Mr. Souder, Mr. Tiahrt, Mr. Hayworth, Mrs. Chenoweth-Hage, 
 Mr. Sam Johnson of Texas, Mr. Goode, Mr. Ryun of Kansas, Mr. Bartlett 
 of Maryland, Mr. Green of Wisconsin, Mr. Jones of North Carolina, Mr. 
  Manzullo, and Mr. Shadegg) introduced the following bill; which was 
                 referred to the Committee on Commerce

_______________________________________________________________________

                                 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.

    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, to be 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 promptly modify the conditions of the approval of such 
drug to establish the additional restriction that the drug may not be 
prescribed by any person other than a licensed physician who meets the 
following requirements:
            (1) The physician is qualified to handle complications 
        resulting from an incomplete abortion or ectopic pregnancy.
            (2) The physician has been trained to perform surgical 
        abortions and has met all applicable legal requirements to 
        perform such abortions.
            (3) The physician is certified for ultrasound dating of 
        pregnancy and detecting ectopic pregnancy.
            (4) The physician has completed a program regarding the 
        prescribing of such drug that uses a curriculum approved by the 
        Secretary.
            (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.
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