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HR8651119th CongressWALLET

Advancing Safe Medications for Moms and Babies Act of 2026

Sponsored By: Representative Castor, Kathy [D-FL-14]

Introduced

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.

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  • 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.*

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Bill Overview

Analyzed Economic Effects

3 provisions identified: 3 benefits, 0 costs, 0 mixed.

Align research rules for pregnant people

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 not later than 180 days after enactment. The change would align agency rules and is intended to make it clearer and easier for sponsors, investigators, and review boards to include pregnant people in clinical trials.

Public education on maternal research

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 a public website that lists and updates trials and registries with a user-friendly interface. The bill authorizes $5,000,000 to be appropriated for each fiscal year from 2027 through 2031 to carry out this work. The campaign authority would sunset on September 30, 2031.

Research priorities for pregnancy and breastfeeding

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 input, publish a work plan within 180 days after enactment, and provide annual reports by October 1 for five fiscal years showing projects, spending, and prioritization rationale. Funding is authorized as needed for fiscal years 2027 through 2031.

Sponsors & CoSponsors

Sponsor

Castor, Kathy [D-FL-14]

FL • D

Cosponsors

  • Rep. Fitzpatrick, Brian K. [R-PA-1]

    PA • R

    Sponsored 5/4/2026

  • Rep. Underwood, Lauren [D-IL-14]

    IL • D

    Sponsored 5/4/2026

Roll Call Votes

No roll call votes available for this bill.

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