[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5646 Introduced in House (IH)]

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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 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.''.
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