Advancing Safe Medications for Moms and Babies Act of 2026
Sponsored By: Representative Castor, Kathy [D-FL-14]
Introduced
Summary
This bill would improve maternal and infant medication safety by prioritizing and funding research that includes pregnant and lactating women and by aligning rules and public outreach to make those studies easier to run and find.
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- Families and pregnant people would get more evidence on medication risks and benefits through prioritized studies and a public website that lists trials and registries. The bill would fund an education campaign to help people find and enroll in those studies.
- Health care providers and caregivers would see targeted outreach and tested messaging about clinical trials and registries, including information on postmarket surveillance and how to identify relevant studies.
- Researchers and NIH would get a formal prioritization process for studies on drugs used in pregnancy and lactation, with criteria for selecting projects, a required work plan within 180 days, annual reports for five years, and authorized funding through 2031.
*Would increase federal spending by authorizing $5.0 million per year for the education campaign for 2027–2031 and additional unspecified NIH funds, raising outlays relative to current law.*
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Bill Overview
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Align FDA rules for pregnant research
This bill would direct the HHS Secretary, through the FDA Commissioner, to harmonize FDA human subject protection rules with HHS rules on including pregnant women in clinical research. The harmonization would explicitly address parts 50 and 56 of title 21, Code of Federal Regulations, as practicable and consistent with law. The Secretary would be required to finalize the harmonized regulations within 180 days after enactment. The change is intended to clarify protections and reduce barriers to including pregnant women in trials.
Education campaign for pregnant women
This bill would require the Secretary of HHS to create an education campaign about including pregnant and lactating women in clinical research. The campaign would inform patients, families, and health care providers about trial benefits, registries, postmarket surveillance, and how to join studies. HHS would do a needs assessment, consult experts and affected communities, test messaging, and publish materials on a public, user-friendly website. Congress would authorize $5,000,000 per year for fiscal years 2027 through 2031 for these activities.
NIH studies on drugs for pregnant women
This bill would require the NIH, through NICHD, to prioritize and carry out research projects on existing and new drugs prescribed for pregnant and lactating women. NIH would set a prioritization process that considers evidence gaps, feasibility, and potential impact, seek stakeholder feedback, ensure qualified investigators, and provide for public comment. The NIH Director would submit a work plan within 180 days of enactment and annual reports by October 1 for five fiscal years. Funding is authorized as may be necessary 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.
View on Congress.gov