I 
119TH CONGRESS 
1ST SESSION H. R. 5646 
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. 
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 Com-
mittee on the Judiciary, for a period to be subsequently determined by 
the Speaker, in each case for consideration of such provisions as fall with-
in 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 Representa-
tives 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’’. 
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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 mitiga-
tion strategy pursuant to such section 505–1 for the 
covered medication; and 
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(2) may not approve a risk evaluation and miti-
gation strategy pursuant to such section for the cov-
ered 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 cov-
ered medication in interstate or foreign commerce in viola-
tion of section 1462 of title 18, United States Code. 
(b) LIABILITY.—A covered entity shall be liable in ac-
cordance 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 at-
tributable, 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 appro-
priate district court of the United States or a State court 
of competent jurisdiction for— 
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(1) compensatory damages; 
(2) punitive damages; and 
(3) attorney’s fees and costs. 
(d) RULES OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to preempt any State law that 
makes available any other remedy to an individual de-
scribed 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.’’. 
Æ 
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