# 119-hr-8651: Advancing Safe Medications for Moms and Babies Act of 2026

119-hr-8651, Advancing Safe Medications for Moms and Babies Act of 2026, is a 119th Congress bill sponsored by Rep. Castor, Kathy [D-FL-14] (D-FL); status introduced; PRIA reads it as touching household money (as of 2026-09-21).

- Canonical: https://policyrisk.com/legislation/119-hr-8651
- As of: 2026-09-21
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-hr-8651
- Congress: 119
- Title: Advancing Safe Medications for Moms and Babies Act of 2026
- Status: introduced
- Introduced: 2026-05-04
- Sponsor: Rep. Castor, Kathy [D-FL-14] (D-FL)
- Cosponsors: 2
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-09-21

## Summary

**Inclusion of pregnant and lactating women in clinical research** is the bill's central goal. It would align FDA and HHS human-subjects rules, fund a public awareness campaign, and charge the NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development to prioritize studies and reporting. - Pregnant and lactating families: Would get clearer information and easier enrollment paths through a public website and outreach materials, backed by a $5.0 million per year awareness campaign for 2027–2031. - Health care providers and researchers: Would face harmonized FDA and HHS protections to help enroll pregnant people in studies, with required FDA regulations finalized within 180 days. - NIH and research infrastructure: NICHD would lead a formal prioritization process for drugs used in pregnancy and lactation, must publish a work plan within 180 days, and provide annual reports for five fiscal years; funding is authorized as necessary to support this work. *This would authorize at least $25.0 million for the awareness campaign over 2027–2031 and additional unspecified NIH funding, increasing federal spending.*

## Cosponsors (2)

- Rep. Fitzpatrick, Brian K. [R-PA-1] (R-PA), 2026-05-04T00:00:00.000Z
- Rep. Underwood, Lauren [D-IL-14] (D-IL), 2026-05-04T00:00:00.000Z

## Provisions PRIA read

- Align research rules for pregnant people: benefit, medium. If enacted, the Secretary of Health and Human Services, acting through the FDA Commissioner, would be required to issue regulations to harmonize FDA human-subject protections (including 21 CFR parts 50 and 56) with HHS rules on including pregnant women in research. The regulations must be finalized…
- Public education on maternal research: benefit, low. If enacted, HHS would create and run a public education campaign to explain the benefits of including pregnant and lactating women in clinical research. The campaign would require stakeholder consultation, a needs assessment, audience targeting, tested messaging (including risk communication), and…
- Research priorities for pregnancy and breastfeeding: benefit, low. If enacted, the NIH Director, through the Eunice Kennedy Shriver National Institute of Child Health and Human Development, would set priorities and fund research on existing and new drugs used by pregnant and lactating women. The Director would develop a prioritization process, seek stakeholder inp…

## Related bills

- 119-hr-7977: Energy Bills Relief Act
- 119-hr-7973: Momnibus Act
- 119-hr-20: Richard L. Trumka Protecting the Right to Organize Act of 2025
- 119-hr-2086: Rights for the TSA Workforce Act
- 119-hr-3151: SHIPS for America Act of 2025
- 119-hr-1589: American Dream and Promise Act of 2025

## Sources
- [119-hr-8651 on Congress.gov](https://www.congress.gov/bill/119th-congress/house-bill/8651)

## Related
- [119-hr-7977: Energy Bills Relief Act](https://policyrisk.com/legislation/119-hr-7977)
- [119-hr-7973: Momnibus Act](https://policyrisk.com/legislation/119-hr-7973)
- [119-hr-20: Richard L. Trumka Protecting the Right to Organize Act of 2025](https://policyrisk.com/legislation/119-hr-20)
- [119-hr-2086: Rights for the TSA Workforce Act](https://policyrisk.com/legislation/119-hr-2086)
- [119-hr-3151: SHIPS for America Act of 2025](https://policyrisk.com/legislation/119-hr-3151)
- [119-hr-1589: American Dream and Promise Act of 2025](https://policyrisk.com/legislation/119-hr-1589)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-hr-8651 (as of 2026-09-21).