HR 5646 Re-checks Congress.gov for new actions and updates the bill's status, and fills in any sponsors, committees, or related bills that are missing. It does not re-pull sponsors/cosponsors/committees/related — those rarely change — and it skips all work if nothing has changed upstream, so it's cheap to click.
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
The bill requires the Secretary of Health and Human Services to withdraw the current Risk Evaluation and Mitigation Strategy (REMS) for mifepristone and approve a REMS identical to the one that was approved in June 2011, which contained more restrictive requirements. The bill prohibits approval of any alternative REMS for mifepristone that differs from the 2011 version. The bill creates a federal civil liability provision allowing individuals who suffer bodily injury or harm to mental health from use of mifepristone imported or transported illegally to sue telehealth providers, pharmacies, or other entities that participated in the importation or transportation, seeking compensatory damages, punitive damages, and attorney's fees. The bill bans all importation of mifepristone into the United States, including by mail. These provisions take effect 90 days after enactment, except for the importation ban which is effective immediately.
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)
8 cosponsors
- Rep. Biggs, Sheri [R-SC-3] (R-SC)
- Rep. Burchett, Tim [R-TN-2] (R-TN)
- Rep. Guest, Michael [R-MS-3] (R-MS)
- Rep. Harrigan, Pat [R-NC-10] (R-NC)
- Rep. Harris, Andy [R-MD-1] (R-MD)
- Rep. LaMalfa, Doug [R-CA-1] (R-CA)
- Rep. Moore, Barry [R-AL-1] (R-AL)
- Rep. Weber, Randy K. Sr. [R-TX-14] (R-TX)
Money behind the sponsor
Top reported contributors to Mary E. Miller’s campaign committee (2024 cycle) — who funds the bill’s sponsor, not a claim about this bill. Data from FEC.
- NULL $22,349
- SAULSBURY INDUSTRIES $13,200
- THOMPSON THRIFT DEVELOPMENT $11,600
- KASPAR LAW COMPANY $6,600
- INDECK ENERGY SERVICES $6,600
Organizations whose employees gave the most — itemized individual contributions grouped by the donor’s reported employer (FEC Schedule A). Full finance for Mary E. Miller → · Outside spending →
Actions (2)
- Sep 30, 2025 Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. · house
- Sep 30, 2025 Introduced in House
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.
Text versions (1)
Bills are re-published as they move (Introduced → Reported → Engrossed → Enrolled …). Each stage below is a separate text; pick two to see what changed. Data from Congress.gov.
Full text
IN THE HOUSE OF REPRESENTATIVES
September 30, 2025
Mrs. Miller of Illinois (for herself, Mr. Moore of Alabama, Mrs. Biggs of South Carolina, Mr. Weber of Texas, Mr. Harrigan, Mr. Burchett, and Mr. LaMalfa) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned
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>
Comments