Protecting Life from Chemical Abortions Act

Subjects: Health

Summary:  <p><b>Protecting Life from Chemical Abortions Act</b></p> <p>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.)</p> <p>The FDA regulates the use of 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 temporarily stopped enforcing the in-person dispensing requirement, which allowed mail-order pharmacies to fill and dispense mifepristone prescriptions. </p> <p>In January 2023, the FDA modified program requirements so as to (1) remove the in-person dispensing requirement, and (2) require pharmacies to be certified in the program in order to dispense mifepristone. The modifications allow retail pharmacies, after receiving certification, to dispense mifepristone pursuant to prescriptions that are written by program-certified prescribers.</p> <p>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. </p> <p>The bill also generally prohibits the declaration of a public health emergency with respect to abortions. </p> <p><br> </p>

<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 384 Introduced in House (IH)]

&lt;DOC&gt;






118th CONGRESS
  1st Session
                                H. R. 384

 To prohibit the use or declaration of a public health emergency with 
              respect to abortion, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 17, 2023

   Mr. Hern (for himself, Mr. Sessions, Mrs. Miller of Illinois, Mr. 
    Duncan, Mr. Aderholt, Mr. Ellzey, Mr. Babin, Mr. Grothman, Mr. 
  Feenstra, Mr. Wenstrup, Mr. Loudermilk, Mr. Guest, Mr. Pfluger, Mr. 
 Fry, Mrs. Harshbarger, Mr. Moolenaar, Mr. Rose, Mr. Jackson of Texas, 
Mr. Cline, Mr. Mast, Mr. Finstad, Mrs. Boebert, Mr. Green of Tennessee, 
Mr. Lamborn, Mr. Baird, Mrs. Hinson, Mr. LaMalfa, Mr. Clyde, Mr. Weber 
of Texas, Mr. Banks, Mr. Webster of Florida, Mr. Langworthy, Mr. Kelly 
of Mississippi, Mr. Rutherford, and Mr. Gosar) 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.
                                 &lt;all&gt;
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