S. 3697

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

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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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