HR 482 IH

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.

February 6, 2001

Mr. VITTER introduced the following bill; which was referred to the Committee on Energy and Commerce

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.

END