II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘RU–486 Patient 

5 Health and Safety Protection Act’’. 


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•S 3939 IS 

1 SEC. 2. ESTABLISHMENT OF RESTRICTIONS REGARDING 

2 PRESCRIBING OF CERTAIN ABORTION DRUG. 

3 (a) IN GENERAL.—With respect to the application 

4 that was submitted under section 505(b) of the Federal 

5 Food, Drug, and Cosmetic Act for the drug mifepristone 

6 (commonly referred to as RU–486, marketed as 

7 MIFEPREX), and that was approved on September 28, 

8 2000, the Secretary of Health and Human Services, acting 

9 through the Commissioner of Food and Drugs, shall with10 in 90 days of the date of enactment of this Act, modify 

11 the conditions of the approval of such drug to establish 

12 the additional restriction that the drug may not be pre13 scribed or administered by any person other than a li14 censed physician who meets the following requirements: 

15 (1) The physician is qualified to personally han16 dle complications resulting from an incomplete abor17 tion or ectopic pregnancy. 

18 (2) The physician has been trained to perform 

19 surgical abortions and has met all current applicable 

20 legal requirements to perform such abortions. 

21 (3) The physician is qualified for ultrasound 

22 dating of pregnancy and detecting of ectopic preg23 nancy. 

24 (4) The physician has completed a program re25 garding the prescribing of such drug that uses a 


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•S 3939 IS 

1 curriculum approved by the Secretary in accordance 

2 with subsection (c)(1). 

3 (5) The physician has admitting privileges at a 

4 hospital to which the physician can travel in one 

5 hour or less, determined on the basis of starting at 

6 the principal medical office of the physician and 

7 traveling to the hospital, using the transportation 

8 means normally used by the physician to travel to 

9 the hospital, and under the average conditions of 

10 travel for the physician. 

11 (6) The physician has been trained to recognize 

12 and treat afebrile infections, in accordance with 

13 guidelines established under subsection (c)(2). 

14 (b) INFORMATIONAL REQUIREMENTS.—With respect 

15 to information provided to patients in connection with the 

16 prescription of the drug referred to in subsection (a), the 

17 Secretary of Health and Human Services shall require 

18 that such patient information include— 

19 (1) an additional strongly worded warning (as 

20 determined by the Secretary of Health and Human 

21 Services) regarding the nature of life-threatening 

22 afebrile infections and instructions on how to recog23 nize afebrile infections, including the fact that 

24 women taking RU–486 and an accompanying 

25 prostaglandin for abortion have died from afebrile 


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•S 3939 IS 

1 infections, hemmorage, heart attack, and rupture of 

2 undetected ectopic pregnancies; and 

3 (2) an additional strongly worded warning (as 

4 determined by the Secretary) against all possible de5 viations from the FDA-approved methods of admin6 istration, such as reduced dosage, increased dosage, 

7 failure to return for supervised administration on 

8 day 3, and vaginal self-administration of 

9 misoprostol. 

10 (c) GUIDELINES.— 

11 (1) CURRICULUM.—The Secretary of Health 

12 and Human Services shall establish guidelines for 

13 the review and approval of curriculum to be used for 

14 purposes of subsection (a)(4). 

15 (2) TRAINING.—The Secretary of Health and 

16 Human Services shall establish guidelines for the 

17 training of physicians for purposes of subsection 

18 (a)(6). 

19 (d) LIMITATION.—With respect to the administration 

20 of a drug referred to in subsection (a), a physician shall 

21 not deviate from the Food and Drug Administration ap22 proved methods of administration of such a drug. 

Æ 


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