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.
(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.
END
