Safeguarding Women from Chemical Abortion Act

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4066 Introduced in Senate (IS)]

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119th CONGRESS
  2d Session
                                S. 4066

To provide that the approved application under the Federal Food, Drug,
   and Cosmetic Act for the drug mifepristone for the purpose of the
termination of intrauterine pregnancy is deemed to have been withdrawn,
   to establish a Federal tort for harm to women caused by chemical
                abortion drugs, and for other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             March 11, 2026

  Mr. Hawley introduced the following bill; which was read twice and
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

To provide that the approved application under the Federal Food, Drug,
   and Cosmetic Act for the drug mifepristone for the purpose of the
termination of intrauterine pregnancy is deemed to have been withdrawn,
   to establish a Federal tort for harm to women caused by chemical
                abortion drugs, 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 ``Safeguarding Women from Chemical
Abortion Act''.

SEC. 2. WITHDRAWAL OF APPROVAL OF THE DRUG MIFEPRISTONE FOR TERMINATION
              OF PREGNANCY.

    Effective upon the expiration of 14 days after the date of the
enactment of this Act:
            (1) Approval of an application submitted under subsection
        (b) of section 505 of the Federal Food, Drug, and Cosmetic Act
        (21 U.S.C. 355) for the drug mifepristone (marketed as
        Mifeprex, and also known as RU-486) with an indication for the
        termination of intrauterine pregnancy, and of any application
        submitted under subsection (j) of such section for a drug with
        the same indication and for which mifepristone is the reference
        drug, is deemed to have been withdrawn under subsection (e) of
        such section.
            (2) For purposes of sections 301(d) and 304 of the Federal
        Food, Drug, and Cosmetic Act (21 U.S.C. 331(d); 334), the
        introduction or delivery for introduction of a drug, the
        approval of which has been withdrawn as described in paragraph
        (1), into interstate commerce shall be considered a violation
        of section 505 of such Act (21 U.S.C. 355).
            (3) The drug mifepristone shall be considered misbranded
        for purposes of sections 301 and 304 of the Federal Food, Drug,
        and Cosmetic Act (21 U.S.C. 331; 334) if the drug bears
        labeling providing that the drug may be used for the
        termination of intrauterine pregnancy or that the drug may be
        used in conjunction with another drug for the termination of
        intrauterine pregnancy.

SEC. 3. FEDERAL TORT FOR HARM TO WOMEN CAUSED BY CHEMICAL ABORTION
              DRUGS.

    (a) Definitions.--In this section:
            (1) Covered entity.--The term ``covered entity'' means a
        person that manufactures a covered medication for introduction
        into interstate commerce.
            (2) Covered medication.--The term ``covered medication''
        means the drug mifepristone (marketed as Mifeprex, and also
        known as RU-486), with an indication for the termination of
        intrauterine pregnancy, approved pursuant to an application
        submitted under subsection (b) or (j) of section 505 of the
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355).
    (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 manufactured by a covered
entity.
    (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. 4. RULE OF CONSTRUCTION.

    Nothing in this Act shall be construed to affect any provision of
section 1461 of title 18, United States Code.
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