RU-486 Patient Health and Safety Protection Act - Requires the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to modify the conditions of approval of the new drug application for mifepristone (commonly referred to as RU-486, marketed as Mifeprex) to establish the additional restriction that the drug may not be prescribed or administered by any person other than a licensed physician who: (1) is qualified to personally handle complications resulting from an incomplete abortion or ectopic pregnancy; (2) has been trained to perform surgical abortions and has met all current applicable legal requirements to perform such abortions; (3) is qualified for ultrasound dating of pregnancy and detecting of ectopic pregnancy; (4) has completed a program regarding the prescribing of such drug that uses a curriculum approved by the Secretary; (5) has admitting privileges at a hospital to which the physician can travel in one hour or less; and (6) has been trained to recognize and treat afebrile infections. Requires the Secretary to establish guidelines for the review and approval of such curriculum and for such training.
Directs the Secretary to require that information provided to patients in connection with the prescription of the drug include additional strongly worded warnings: (1) regarding the nature of life-threatening afebrile infections and instructions on how to recognize such infections; and (2) against all possible deviations from FDA-approved methods of administration.
Prohibits a physician from deviating from FDA-approved methods of administration of such a drug.
[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>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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