S. 3697Senate119th Congress (2025-2027)In Committee

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.

Introduced January 27, 2026

AI-Generated Summary

Updated February 19, 2026 at 3:55 AM UTC

The SAVE Moms and Babies Act of 2026 amends the Federal Food, Drug, and Cosmetic Act to block the FDA from approving new abortion‑inducing drugs and from allowing investigational use of such drugs. It also adds strict new rules for drugs already approved, limiting how they can be labeled, prescribed, and dispensed, and requiring extensive certification and reporting requirements for prescribers. The bill affects the FDA, drug manufacturers, health‑care practitioners who prescribe these drugs, and patients seeking them.

Key Provisions

  • The FDA may not approve any new drug that is intended to terminate a pregnancy, nor grant investigational‑use exemptions for such drugs or for studies that intentionally destroy an unborn child.
  • For abortion drugs already approved before the law takes effect, the FDA cannot allow labeling that permits use after 70 days of gestation or dispensing by anyone other than the prescribing practitioner in person.
  • Existing abortion drugs must be subject to a risk‑evaluation and mitigation strategy that requires prescribers to be certified, able to accurately date pregnancies, diagnose ectopic pregnancies, provide surgical care for complications, ensure access to blood‑transfusion facilities, and report serious adverse events.
  • Dispensing of these drugs is limited to in‑person administration in clinics, medical offices, or hospitals; they may not be dispensed in pharmacies or other settings.
  • Prescribers must give patients written information about serious risks and obtain acknowledgment; manufacturers, prescribers, and other health‑care providers must report all adverse events to the FDA without identifying patients.
  • Any investigational‑use exemptions for abortion drugs granted before enactment are automatically rescinded three years after the law’s effective date if the new prohibitions apply.

Legislative Activity

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1 earlier action
SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S292)

January 27, 2026

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SenateIntro Referral

Introduced in Senate

January 27, 2026

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S292)

January 27, 2026

Floor Debate

13 members

What members said about S. 3697 on the floor

8 Republicans5 Democrats
Bill Cassidy
Sen. Bill CassidyR-LA · Jan 27, 2026

Mr. President, this past Friday, thousands of Americans, young and old, marched peacefully to call attention to the sanctity and inherent value of each life. Their advocacy and passion drive our work…

Charles E. Schumer
Sen. Charles E. SchumerD-NY · Jan 27, 2026

Mr. President, the Senate gavels into session with the conscience of this Nation shaken to its core. Last Saturday, in the Eat Street district of Minneapolis, 37-year-old Alex Pretti was shot and…

John Thune
Sen. John ThuneR-SD · Jan 27, 2026

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, I ask unanimous consent to waive the mandatory quorum call with respect to the motion to proceed…

Mazie K. Hirono
Sen. Mazie K. HironoD-HI · Jan 27, 2026

Mr. President, I rise today in opposition to S. 3627, the so-called Pregnant Students' Rights Act. But before I begin, I want to take a moment to honor Alex Pretti and Renee Good, who were…

Cindy Hyde-Smith
Sen. Cindy Hyde-SmithR-MS · Jun 24, 2026

Mr. President, 4 years ago today, our Nation took the historic step when the U.S. Supreme Court's Dobbs decision overturned the so-called right to end a baby's life in America and returned the…

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Angela D. Alsobrooks
Sen. Angela D. AlsobrooksD-MD · Jun 24, 2026

Mr. President, reserving the right to object. Let's be clear. This bill would roll back the clock by 25 years. It limits access to a safe and effective medication that has been approved by the FDA…

Joni Ernst
Sen. Joni ErnstR-IA · Jan 27, 2026

Mr. President, last Friday, thousands of Americans and many Iowans braved nearly freezing temperatures to join this year's March for Life. I stand united with them in a simple truth: Life is a gift…

Katie Boyd Britt
Sen. Katie Boyd BrittR-AL · Jan 27, 2026

Mr. President, I rise today to celebrate life. Last week, our Nation's Capital saw thousands who traveled here to march in the 53rd annual March for Life. My team was proud to host many Alabamians…

Ashley Moody
Sen. Ashley MoodyR-FL · Jan 27, 2026

Mr. President, it is an honor to stand on the Senate floor today and speak in support of my Pregnant Students' Rights Act. Today, I am proud to continue this important work to protect the most…

Cindy Hyde-Smith
Sen. Cindy Hyde-SmithR-MS · Jan 27, 2026

Last week, tens of thousands of Americans of all ages, from across the country, gathered in our Nation's Capital to march for the most vulnerable among us: preborn children. I am so proud to live in…

Cindy Hyde-Smith
Sen. Cindy Hyde-SmithR-MS · Jan 27, 2026

Last week, tens of thousands of Americans of all ages, from across the country, gathered in our Nation's Capital to march for the most vulnerable among us: preborn children. I am so proud to live in…

Chuck Grassley
Sen. Chuck GrassleyR-IA · Jan 27, 2026

Mr. President, I move to proceed to Calendar No. 302, Mr. President, yesterday marked the start of the 2026 tax filing season. This year, taxpayers can expect to see some of the largest tax refunds…

Cindy Hyde-Smith
Sen. Cindy Hyde-SmithR-MS · Jan 27, 2026

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, today, we are also voting on another important effort to protect pregnant moms: Senator Moody's…

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Chris Van Hollen
Sen. Chris Van HollenD-MD · Jan 27, 2026

Mr. President, today we consider S. 3627. This legislation would limit the information students receive about their healthcare and family planning options. No one disagrees that pregnant and…

John Barrasso
Sen. John BarrassoR-WY · Jan 27, 2026

The following Senators are necessarily absent: the Senator from West Virginia (Mrs. Capito), the Senator from Tennessee (Mr. Hagerty), the Senator from West Virginia (Mr. Justice), the Senator from…

Richard J. Durbin
Sen. Richard J. DurbinD-IL · Jan 27, 2026

I announce that the Senator from Pennsylvania (Mr. Fetterman) and the Senator from Georgia (Mr. Warnock) are necessarily absent.

Bill Text

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Introduced in SenateIssued January 27, 2026

II

119th CONGRESS

2d Session

S. 3697

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.

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.

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.