Protecting Life from Chemical Abortions Act

Bill: 118-hr-384
Sponsor: full_name: Rep. Hern, Kevin [R-OK-1]
Introduced: 2023-01-17
Policy area: Health
Latest action: action_date: 2023-01-27
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2023-01-17
action_desc: Introduced in House
text: <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>

tv_txt: I 118th CONGRESS 1st Session H. R. 384 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.

1. Short title This Act may be cited as the Protecting Life from Chemical Abortions Act . 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. 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.