Bill Summary
The "Safeguarding Women from Chemical Abortion Act" is a legislative proposal aimed at addressing the use of the drug mifepristone, commonly known as Mifeprex or RU-486, which is used for terminating intrauterine pregnancies.
Key provisions of the bill include:
1. **Withdrawal of Approval**: The bill mandates that the approval for mifepristone as an abortion medication is deemed withdrawn 14 days after the enactment of the Act. This means that the drug would no longer be legally available for the purpose of terminating pregnancies.
2. **Labeling and Misbranding**: Following the withdrawal, any labeling that suggests mifepristone can be used for abortion would be considered misbranding, making its sale or distribution a violation of federal law.
3. **Establishment of Federal Tort**: The bill introduces a legal framework allowing individuals who suffer physical or mental harm from using mifepristone to file lawsuits against manufacturers of the drug. It establishes liability for covered entities (manufacturers) and allows for claims for compensatory and punitive damages, as well as attorneys’ fees.
4. **Private Right of Action**: Individuals harmed by mifepristone can pursue civil actions in federal or state courts against manufacturers, emphasizing the bill's intent to hold these entities accountable.
5. **Effect on State Laws**: The bill clarifies that it does not preempt state laws that provide additional remedies for individuals harmed by the drug.
Overall, this legislation seeks to eliminate the availability of mifepristone for abortion purposes and establish legal recourse for any harms associated with its use.
Possible Impacts
The proposed legislation, titled the "Safeguarding Women from Chemical Abortion Act," could affect people in several significant ways:
1. **Access to Medication Abortion**: By deeming the approval of mifepristone withdrawn, the legislation would effectively ban the use of this drug for terminating pregnancies. This would limit access to medication abortion for women who seek this method, potentially forcing them to pursue surgical options or travel to jurisdictions where such options remain available, thereby increasing logistical and financial burdens.
2. **Legal Liability for Manufacturers**: The establishment of a federal tort for harm caused by chemical abortion drugs means that manufacturers of mifepristone could face civil lawsuits from individuals who claim to have suffered bodily injury or harm to mental health due to the use of the drug. This could lead to increased legal challenges for pharmaceutical companies and potentially discourage the development and distribution of similar medications, impacting future access to reproductive healthcare options.
3. **Psychological and Emotional Impact**: Women who rely on mifepristone for terminating pregnancies may experience heightened psychological stress and emotional distress due to the sudden removal of this option. The legislation could also foster stigmatization of abortion services and create a more hostile environment for women seeking reproductive healthcare, potentially affecting their mental health and overall well-being.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4066 Introduced in Senate (IS)]
<DOC>
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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