SAVE Moms and Babies Act of 2026
- Bill Number
- S. 3697
- Origin Chamber
- Senate
- Congress
- 119th Congress, Session 2
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2026-01-27: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S292)
- Last Updated
- 2026-06-23T11:03:26Z
AI-Generated Summary
Purpose of the Legislation
This bill, titled the "Support And Value Expectant Moms and Babies Act of 2026" (or "SAVE Moms and Babies Act of 2026"), aims to restrict access to abortion drugs by amending the Federal Food, Drug, and Cosmetic Act (FD&C Act). It prohibits the U.S. Food and Drug Administration (FDA) from approving new abortion drugs or allowing their use in research that harms unborn children. For drugs already approved (such as mifepristone), it introduces stricter safety and distribution rules to limit their use and ensure oversight.
Key Provisions
- Prohibitions on New Approvals and Research:
- The FDA cannot approve applications to market new abortion drugs.
- The FDA cannot grant "investigational use exemptions" (temporary permissions for testing drugs before full approval) for abortion drugs or any research that knowingly destroys an unborn child of a pregnant woman.
- Existing investigational exemptions granted before the bill's enactment will be canceled after 3 years if they involve prohibited activities.
- Restrictions on Previously Approved Abortion Drugs:
- No changes to drug labeling can expand use beyond 70 days of gestation (pregnancy period counted from the first day of the last menstrual period) or allow dispensing without in-person administration by the prescribing doctor.
- These drugs must be treated as prescription-only medications requiring direct handover from the prescriber (not through pharmacies or mail).
- A mandatory "Risk Evaluation and Mitigation Strategy" (REMS, a FDA safety program) must include:
- Certification for prescribing doctors (excluding pharmacists), who must demonstrate skills to accurately date pregnancies, diagnose ectopic pregnancies (when a fertilized egg implants outside the uterus), perform surgery for incomplete abortions or severe bleeding, ensure access to emergency facilities for blood transfusions or resuscitation, and report deaths or adverse events (using non-identifiable patient codes and drug package numbers).
- In-person dispensing only in clinics, medical offices, or hospitals by the certified prescriber.
- Provision of written risk information to patients (e.g., serious complications like heavy bleeding or infection), with patient acknowledgment.
- Required reporting of all adverse events (e.g., death, ectopic pregnancy, hospitalization, severe infection, or blood loss needing transfusion) to the FDA by manufacturers, prescribers, and other healthcare providers (without patient-identifying details).
- Reporting of drug administration to match state laws on surgical abortions (or equivalent if no state law exists).
- Definitions:
- Abortion drug: Any drug or substance intended to end a known pregnancy by killing the unborn child, excluding cases aimed at live birth, removing a dead fetus, or treating ectopic pregnancy.
- Unborn child: A human organism from fertilization until live birth (as defined in federal law).
- Adverse event: Includes death, ectopic pregnancy, hospitalization, transfusion-requiring blood loss, or severe infections like sepsis.
- Health care practitioner: Licensed professionals authorized to prescribe certain prescription drugs.
- Rule of Construction: States and the federal government can add further restrictions on abortion drugs under other laws.
Significant Changes to Existing Law
- Adds a new subsection (bb) to Section 505 of the FD&C Act, which governs drug approvals, explicitly banning new abortion drug approvals and research exemptions while redesignating an existing subsection for numbering.
- For drugs like mifepristone (approved in 2000 and used for medication abortion up to 10 weeks), it reverses or limits post-approval expansions, such as 2016 and 2021 FDA changes allowing telemedicine prescribing and later gestation use.
- Introduces mandatory REMS elements tailored to abortion drugs, expanding beyond general FDA safety requirements to enforce in-person care, prescriber certification, and detailed reporting—stricter than current rules for similar medications.
- Requires all healthcare providers (not just prescribers) to report adverse events related to these drugs, creating broader monitoring than under existing FDA adverse event reporting systems.
Potential Impacts
- On Government Agencies: The FDA will face new enforcement duties, including reviewing and rescinding exemptions, certifying prescribers, and processing expanded adverse event reports, potentially increasing administrative workload and legal challenges to implementation.
- On Citizens: Pregnant individuals seeking medication abortions (a non-surgical option used in over half of U.S. abortions) may face reduced access, higher costs, and barriers like mandatory in-person visits, especially in rural or underserved areas. This could shift more abortions to surgical procedures or delay care, affecting health outcomes.
- On International Relations: No direct impacts mentioned, though it could influence U.S. drug export policies or global views on reproductive health if manufacturers face U.S.-specific restrictions.
Main Stakeholders Affected
- Pregnant Women and Patients: Primary users of abortion drugs, who may experience limited options and increased safety requirements.
- Healthcare Providers: Doctors (especially OB-GYNs) must meet certification and reporting standards; pharmacists are excluded from dispensing, potentially reducing their role.
- Drug Manufacturers: Companies producing abortion drugs (e.g., those making mifepristone) face ongoing restrictions, reporting mandates, and no path for new approvals, possibly leading to market withdrawal.
- FDA and Regulators: Directly tasked with enforcement, monitoring, and strategy implementation.
- Advocacy Groups: Anti-abortion organizations may support the restrictions, while reproductive rights groups could oppose them as barriers to care.
- States: Can layer additional rules but must align reporting with federal standards.
Notable Legal, Constitutional, or Political Implications
- Legal Implications: The bill could face lawsuits challenging FDA authority limits or drug access restrictions, building on recent court cases like those involving mifepristone's approval. It preserves state-level abortion regulations post the 2022 Dobbs v. Jackson decision (which ended federal abortion rights), but federalizes drug-specific rules.
- Constitutional Implications: May raise questions under the Due Process Clause (14th Amendment) regarding bodily autonomy or equal protection, especially if seen as disproportionately burdening low-income or rural women. It defines "unborn child" from fertilization, aligning with fetal personhood debates but not granting full legal rights.
- Political Implications: Introduced by a large bipartisan group of Senate Republicans, it reflects ongoing national divides on abortion post-Roe v. Wade overturn. Passage could energize conservative bases but provoke backlash in pro-choice states, influencing midterm or future elections. The 3-year grace period for research suggests a phased approach to avoid immediate disruption.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (34)
Sen. Daines, Steve [R-MT], Sen. Risch, James E. [R-ID], Sen. Rounds, Mike [R-SD], Sen. Wicker, Roger F. [R-MS], Sen. Lankford, James [R-OK], Sen. McConnell, Mitch [R-KY], Sen. Lummis, Cynthia M. [R-WY], Sen. Cruz, Ted [R-TX], Sen. Banks, Jim [R-IN], Sen. Marshall, Roger [R-KS], Sen. Britt, Katie Boyd [R-AL], Sen. Scott, Rick [R-FL], Sen. Hawley, Josh [R-MO], Sen. Crapo, Mike [R-ID], Sen. Budd, Ted [R-NC], Sen. Graham, Lindsey [R-SC], Sen. Cassidy, Bill [R-LA], Sen. Cornyn, John [R-TX], Sen. Ernst, Joni [R-IA], Sen. Lee, Mike [R-UT], Sen. Cramer, Kevin [R-ND], Sen. Ricketts, Pete [R-NE], Sen. Fischer, Deb [R-NE], Sen. Kennedy, John [R-LA], Sen. Hoeven, John [R-ND], Sen. Young, Todd [R-IN], Sen. Hagerty, Bill [R-TN], Sen. Cotton, Tom [R-AR], Sen. Moran, Jerry [R-KS], Sen. Blackburn, Marsha [R-TN], Sen. Barrasso, John [R-WY], Sen. Tuberville, Tommy [R-AL], Sen. Thune, John [R-SD], Sen. Boozman, John [R-AR]
Recent Actions
- 2026-01-27: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S292)
- 2026-01-27: Introduced in Senate
Bill Versions
- Support And Value Expectant Moms and Babies Act of 2026 — issued 2026-01-27 — PDF (8 pages)