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Restoring Safeguards for Dangerous Abortion Drugs Act
To require the Secretary of Health and Human Services to approve a risk evaluation and mitigation strategy for mifepristone that is identical to the strategy previously approved, and for other purposes.
Summary
This bill would require the Secretary of Health and Human Services to replace the current risk evaluation and mitigation strategy (safety requirements) for mifepristone with the version approved in June 2011, and prohibit the Secretary from adopting different safety requirements for the drug in the future. It would create a federal private right of action allowing individuals to sue telehealth providers, pharmacies, or other entities that knowingly import or transport mifepristone in violation of law, with the ability to recover compensatory damages, punitive damages, and attorney's fees. The bill also would ban all importation of mifepristone into the United States. These provisions take effect 90 days after enactment.
AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.
Sponsor (1)
- Sen. Hawley, Josh [R-MO] (R-MO)
Actions (2)
- May 6, 2025 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. · senate
- May 6, 2025 Introduced in Senate
Similar bills (6)
Bills with similar text or summary — includes reintroductions across Congresses. Ranked by semantic similarity of the bill text (computed locally); a neutral discovery aid, not a claim the bills are duplicates.
Full text
IN THE SENATE OF THE UNITED STATES
May 6, 2025
Mr. Hawley introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions
A BILL
To require the Secretary of Health and Human Services to approve a risk evaluation and mitigation strategy for mifepristone that is identical to the strategy previously approved, 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 “Restoring Safeguards for Dangerous Abortion Drugs Act”.
SEC. 2. DEFINITION.
In this Act, the term “covered medication” means mifepristone, also known by the brand names, Mifeprex and Korlym, and the developmental code name, RU-486.
SEC. 3. MIFEPRISTONE REMS.
(a) In General.—Not later than 90 days after the date of enactment of this Act, the Secretary of Health and Human Services shall—
(1) withdraw approval of the risk evaluation and mitigation strategy pursuant to section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1) for the covered medication that is in effect on the date of enactment of this Act; and
(2) approve a risk evaluation and mitigation strategy for the covered medication that is identical to the risk evaluation and mitigation strategy for such covered medication that was approved by such Secretary in June 2011.
(b) Restriction.—Notwithstanding any provision of section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1), the Secretary of Health and Human Services—
(1) shall require a risk evaluation and mitigation strategy pursuant to such section 505-1 for the covered medication; and
(2) may not approve a risk evaluation and mitigation strategy pursuant to such section for the covered medication that is different from the strategy described in subsection
(a)(2).
SEC. 4. FEDERAL TORT FOR HARM TO WOMEN CAUSED BY ABORTION DRUGS.
(a) Definition.—In this section, the term “covered entity” means a telehealth provider, pharmacy, or any other person who knowingly imports or transports a covered medication in interstate or foreign commerce in violation of section 1462 of title 18, United States Code.
(b) Liability.—A covered entity shall be liable in accordance with this section to any individual who suffers bodily injury or harm to mental health (including any physical, psychological, emotional, or physiological harm) that is attributable, in whole or in part, to the individual’s use of a covered medication imported or transported as described in subsection (a).
(c) Private Right of Action.—An individual who suffers bodily injury or harm to mental health that is attributable, in whole or in part, to the individual’s use of a covered medication as described in subsection (b) may bring a civil action against the covered entity in an appropriate district court of the United States or a State court of competent jurisdiction for—
(1) compensatory damages;
(2) punitive damages; and
(3) attorney’s fees and costs.
(d) Rules of Construction.—Nothing in this section shall be construed to preempt any State law that makes available any other remedy to an individual described in subsection (b).
(e) Effective Date.—This section shall take effect on the date that is 90 days after the date of enactment of this Act.
SEC. 5. BAN ON IMPORTATION.
Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381) is amended—
(1) in the third sentence of subsection (a), by inserting “or is mifepristone,” after “under section 569D,”; and
(2) in subsection (d)(1), by adding at the end the following:
“(C) Notwithstanding any other provision of law, no person may import the drug mifepristone into the United States, including by mailing such drug to individuals.”. <all>
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