SAVE Moms and Babies Act of 2026

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3697 Introduced in Senate (IS)]

<DOC>

119th CONGRESS
  2d Session
                                S. 3697

   To amend the Federal Food, Drug, and Cosmetic Act to prohibit the
    approval of new abortion drugs, to prohibit investigational use
  exemptions for abortion drugs, and to impose additional regulatory
 requirements with respect to previously approved abortion drugs, and
                          for other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                            January 27, 2026

 Mrs. Hyde-Smith (for herself, Mr. Daines, Mr. Risch, Mr. Rounds, Mr.
 Wicker, Mr. Lankford, Mr. McConnell, Ms. Lummis, Mr. Cruz, Mr. Banks,
Mr. Marshall, Mrs. Britt, Mr. Scott of Florida, Mr. Hawley, Mr. Crapo,
Mr. Budd, Mr. Graham, Mr. Cassidy, Mr. Cornyn, Ms. Ernst, Mr. Lee, Mr.
Cramer, Mr. Ricketts, Mrs. Fischer, Mr. Kennedy, Mr. Hoeven, Mr. Young,
Mr. Hagerty, Mr. Cotton, Mr. Moran, and Mrs. Blackburn) introduced the
 following bill; which was read twice and referred to the Committee on
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

   To amend the Federal Food, Drug, and Cosmetic Act to prohibit the
    approval of new abortion drugs, to prohibit investigational use
  exemptions for abortion drugs, and to impose additional regulatory
 requirements with respect to previously approved 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 ``Support And Value Expectant Moms and
Babies Act of 2026'' or the ``SAVE Moms and Babies Act of 2026''.

SEC. 2. ABORTION DRUGS PROHIBITED.

    (a) In General.--Section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) is amended--
            (1) by redesignating the second subsection (z), as added by
        section 3601(a) of division FF of Public Law 117-328, as
        subsection (aa); and
            (2) by adding at the end the following:
    ``(bb) Abortion Drugs.--
            ``(1) Prohibitions.--The Secretary shall not approve--
                    ``(A) any application submitted under subsection
                (b) or (j) for marketing an abortion drug; or
                    ``(B) grant an investigational use exemption under
                subsection (i) for--
                            ``(i) an abortion drug; or
                            ``(ii) any investigation in which the
                        unborn child of a woman known to be pregnant is
                        knowingly destroyed.
            ``(2) Previously approved abortion drugs.--If an approval
        described in paragraph (1) is in effect for an abortion drug as
        of the date of enactment of the Support And Value Expectant
        Moms and Babies Act of 2026, the Secretary shall--
                    ``(A) not approve any labeling change--
                            ``(i) to approve the use of such abortion
                        drug after 70 days gestation; or
                            ``(ii) to approve the dispensing of such
                        abortion drug by any means other than in-person
                        administration by the prescribing health care
                        practitioner;
                    ``(B) treat such abortion drug as subject to
                section 503(b)(1); and
                    ``(C) require such abortion drug to be subject to a
                risk evaluation and mitigation strategy under section
                505-1 that at a minimum--
                            ``(i) requires health care practitioners
                        who prescribe such abortion drug--
                                    ``(I) to be certified in accordance
                                with the strategy; and
                                    ``(II) to not be acting in their
                                capacity as a pharmacist;
                            ``(ii) as part of the certification process
                        referred to in clause (i), requires such
                        practitioners--
                                    ``(I) to have the ability to assess
                                the duration of pregnancy accurately;
                                    ``(II) to have the ability to
                                diagnose ectopic pregnancies;
                                    ``(III) to have the ability to
                                provide surgical intervention in cases
                                of incomplete abortion or severe
                                bleeding;
                                    ``(IV) to have the ability to
                                ensure patient access to medical
                                facilities equipped to provide blood
                                transfusions and resuscitation, if
                                necessary; and
                                    ``(V) to report any deaths or other
                                adverse events associated with the use
                                of such abortion drug to the Food and
                                Drug Administration and to the
                                manufacturer of such abortion drug,
                                identifying the patient by a non-
                                identifiable reference and the serial
                                number from each package of such
                                abortion drug;
                            ``(iii) limits the dispensing of such
                        abortion drug to patients--
                                    ``(I) in a clinic, medical office,
                                or hospital by means of in-person
                                administration by the prescribing
                                health care practitioner; and
                                    ``(II) not in pharmacies or any
                                setting other than the health care
                                settings described in subclause (I);
                            ``(iv) requires the prescribing health care
                        practitioner to give to the patient
                        documentation on any risk of serious
                        complications associated with use of such
                        abortion drug and receive acknowledgment of
                        such receipt from the patient;
                            ``(v) requires all known adverse events
                        associated with such abortion drug to be
                        reported, excluding any individually
                        identifiable patient information, to the Food
                        and Drug Administration by the--
                                    ``(I) manufacturers of such
                                abortion drug; and
                                    ``(II) prescribers of such abortion
                                drug; and
                            ``(vi) requires reporting of administration
                        of the abortion drug as required by State law,
                        or in the absence of a State law regarding such
                        reporting, in the same manner as a surgical
                        abortion.
            ``(3) Reporting on adverse events by other health care
        practitioners.--The Secretary shall require all other health
        care practitioners to report to the Food and Drug
        Administration any adverse events experienced by their patients
        that are connected to use of an abortion drug, excluding any
        individually identifiable patient information.
            ``(4) Rule of construction.--Nothing in this section shall
        be construed to restrict the authority of the Federal
        Government, or of a State, to establish, implement, and enforce
        requirements and restrictions with respect to abortion drugs
        under provisions of law other than this section that are in
        addition to the requirements and restrictions under this
        section.
            ``(5) Definitions.--In this section:
                    ``(A) The term `abortion drug' means any drug,
                substance, or combination of drugs or substances that
                is intended for use or that is in fact used
                (irrespective of how the product is labeled) to
                intentionally kill the unborn child of a woman known to
                be pregnant, or to intentionally terminate the
                pregnancy of a woman known to be pregnant, with an
                intention other than--
                            ``(i) to produce a live birth;
                            ``(ii) to remove a dead unborn child; or
                            ``(iii) to treat an ectopic pregnancy.
                    ``(B) The term `adverse event' includes each of the
                following:
                            ``(i) A fatality.
                            ``(ii) An ectopic pregnancy.
                            ``(iii) A hospitalization.
                            ``(iv) A blood loss requiring a
                        transfusion.
                            ``(v) An infection, including endometritis,
                        pelvic inflammatory disease, and pelvic
                        infections with sepsis.
                            ``(vi) A severe infection.
                    ``(C) The term `gestation' means the period of days
                of pregnancy beginning on the first day of the last
                menstrual period.
                    ``(D) The term `health care practitioner' means any
                individual who is licensed, registered, or otherwise
                permitted, by the United States or the jurisdiction in
                which the individual practices, to prescribe drugs
                subject to section 503(b)(1).
                    ``(E) The term `unborn child' means an individual
                organism of the species homo sapiens, beginning at
                fertilization, until the point of being born alive as
                defined in section 8(b) of title 1, United States
                Code.''.
    (b) Ongoing Investigational Use.--In the case of any
investigational use of a drug pursuant to an investigational use
exemption under section 505(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(i)) that was granted before the date of enactment of
this Act, such exemption is deemed to be rescinded as of the day that
is 3 years after the date of enactment of this Act if the Secretary
would be prohibited by section 505(bb)(1)(B) of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a), from granting such
exemption as of such day.
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