Protecting Life from Chemical Abortions Act
This bill nullifies certain changes made by the Food and Drug Administration (FDA) to dispensing requirements for mifepristone. (Mifepristone is a drug that is approved to end pregnancies through 10 weeks gestation when used in conjunction with the drug misoprostol. The procedure is often referred to as medication abortion or the abortion pill.)
The FDA regulates mifepristone through the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) program. The program requires health care providers to comply with certain requirements in order to prescribe or dispense mifepristone to end a pregnancy; the program previously included an in-person dispensing requirement that required mifepristone to be directly dispensed to patients in clinics, medical offices, or hospitals. During the COVID-19 public health emergency, the FDA stopped enforcing the in-person dispensing requirement, which allowed mail-order pharmacies to fill and dispense mifepristone prescriptions.
In January 2023, the FDA modified program requirements so as to (1) remove the in-person dispensing requirement, and (2) require pharmacies to be program-certified in order to dispense mifepristone. The modifications allow certified retail pharmacies to dispense mifepristone pursuant to prescriptions that are written by certified prescribers.
The bill nullifies the January 2023 changes and prohibits the FDA from (1) exercising any enforcement discretion with respect to program requirements, or (2) reducing program protections until every state submits certain data regarding abortions to the Centers for Disease Control and Prevention.
The bill also generally prohibits the declaration of a public health emergency with respect to abortions.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1525 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 1525
To prohibit the use or declaration of a public health emergency with
respect to abortion, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 24, 2025
Mr. Hern of Oklahoma (for himself, Mr. Aderholt, Mr. Feenstra, Mr.
Moolenaar, Mr. Baird, Mr. Weber of Texas, Mr. Webster of Florida, Mr.
Crenshaw, Mr. Newhouse, Mr. Green of Tennessee, Ms. Boebert, Mr.
Rutherford, Mr. Bost, Mr. Guest, Mr. Self, Mr. Downing, Mrs. Miller of
Illinois, Mr. Davidson, Mr. Rose, Mr. Harrigan, and Mr. LaMalfa)
introduced the following bill; which was referred to the Committee on
Energy and Commerce
_______________________________________________________________________
A BILL
To prohibit the use or declaration of a public health emergency with
respect to abortion, and for other purposes.
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 ``Protecting Life from Chemical
Abortions Act''.
SEC. 2. NO DECLARATION OF PUBLIC HEALTH EMERGENCY WITH RESPECT TO
ABORTION.
(a) Prohibition.--The Secretary of Health and Human Services shall
not use or declare any public health emergency under section 319 or
319F-3 of the Public Health Service Act (42 U.S.C. 247d, 247d-6b) with
respect to abortion.
(b) Termination of Any Declaration in Effect.--Any declaration
described in subsection (a) that is in effect as of the date of
enactment of this Act is hereby terminated.
SEC. 3. LIMITATIONS ON ABORTION DRUG.
(a) In General.--The Secretary of Health and Human Services, the
Commissioner of Food and Drugs, or any other official within the
Department of Health and Human Services, with respect to the applicable
risk evaluation and mitigation strategy under section 505-1 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1) relating to
abortion drugs--
(1) may not exercise enforcement discretion with respect to
any requirement under such strategy; and
(2) shall, effective on the date of the enactment of this
Act, reinstate the requirement under such strategy that
abortion drugs be dispensed in only clinics, medical offices,
and hospitals by or under the supervision of a certified health
care provider (commonly referred to as the ``in-person
dispensing requirement'').
(b) Other Limitations.--With respect to the applicable risk
evaluation and mitigation strategy under section 505-1 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355-1) relating to an abortion
drug, the Secretary of Health and Human Services, the Commissioner of
Food and Drugs, or any other official within the Department of Health
and Human Services--
(1) may not reduce protections (including by means of any
update) in such strategy until every State submits to the
abortion surveillance system of the Centers for Disease Control
and Prevention the abortion data collected in the aggregate
from the States and entered into a standardized worksheet that
includes questions on the variables specified in subsection
(c); and
(2) may not waive the requirement under such strategy that
such drugs be dispensed in only clinics, medical offices, and
hospitals by or under the supervision of a certified health
care provider (commonly referred to as the ``in-person
dispensing requirement'').
(c) Mandatory Variables.--The mandatory variables specified in this
subsection shall be treated as mandatory questions for purposes of
section 1903(bb) of the Social Security Act (42 U.S.C. 1396b(bb)) and
shall include the following:
(1) Maternal age in years.
(2) Gestational age in completed weeks at the time of
abortion.
(3) Maternal race.
(4) Maternal ethnicity.
(5) Maternal race by ethnicity.
(6) The abortion method type.
(7) Maternal marital status.
(8) Previous pregnancies of the mother, including the
number of previous live births, the number of previous induced
abortions, and the number of previous spontaneous abortions.
(9) Maternal residence (State or county).
(10) Whether the child survived the abortion.
(11) Congenital anomalies.
(d) Definitions.--In this section:
(1) The term ``abortion'' means the use or provision of any
instrument, medicine, drug, or any other substance or device--
(A) to intentionally kill the unborn child of a
woman known to be pregnant; or
(B) to intentionally terminate the pregnancy of a
woman known to be pregnant, with an intention other
than--
(i) after viability to produce a live birth
that, if premature, is medically indicated, and
to preserve the life and health of the child
born alive;
(ii) to treat an ectopic pregnancy; or
(iii) to remove a dead unborn child.
(2) The term ``abortion drug'' means any medicine, drug, or
any other substance or combination of drugs, medicine, or
substances used for an abortion.
(3) The term ``certified health care provider'' means a
health care provider that has completed a Prescriber Agreement
Form pursuant to the elements for safe use under the applicable
risk evaluation and mitigation strategy under section 505-1 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1)
relating to abortion drugs, under which the provider agrees to
the following:
(A) The provider has the following qualifications:
(i) Ability to assess the duration of
pregnancy accurately.
(ii) Ability to diagnose ectopic
pregnancies.
(iii) Ability to provide surgical
intervention in cases of incomplete abortion or
severe bleeding, or to have made plans to
provide such care through others, and ability
to assure patient access to medical facilities
equipped to provide blood transfusions and
resuscitation, if necessary.
(B) The provider will follow the guidelines for use
of mifepristone under the applicable risk evaluation
and mitigation strategy under section 505-1 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1)
relating to abortion drugs.
(4) The term ``unborn child'' means an individual organism
of the species homo sapiens, beginning at fertilization, until
the point of being born alive as defined in section 8(b) of
title 18, United States Code.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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