Advancing Safe Medications for Moms and Babies Act of 2026
- Bill Number
- H.R. 8651
- Origin Chamber
- House
- Congress
- 119th Congress, Session 2
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2026-05-04: Referred to the House Committee on Energy and Commerce.
- Last Updated
- 2026-05-18T16:13:07Z
AI-Generated Summary
Advancing Safe Medications for Moms and Babies Act of 2026 (H.R. 8651)
Purpose
This bill aims to promote the safe inclusion of pregnant and lactating women in clinical research by updating regulations, raising awareness, and prioritizing related research. It seeks to address gaps in medical knowledge about drugs used during pregnancy and breastfeeding, ultimately benefiting maternal and infant health.
Key Provisions
- Regulatory Harmonization (Sec. 2): Requires the Secretary of Health and Human Services (HHS), through the Food and Drug Administration (FDA), to align FDA rules on protecting human research subjects (e.g., informed consent and ethics reviews) with broader HHS rules on including pregnant women in studies. Final rules due within 180 days of enactment.
- Education Campaign (Sec. 3): Directs HHS, in consultation with CDC and NIH, to launch a public awareness campaign targeting patients, families, and providers. Covers benefits of inclusion in research, available clinical trials/registries, post-market drug monitoring, and easy enrollment methods. Includes needs assessment, website with trial listings, and $5 million authorized annually (FY 2027–2031).
- Research Prioritization (Sec. 4): Mandates NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to fund priority studies on drugs for pregnant/lactating women. Establishes a prioritization process based on evidence gaps, feasibility, and potential impact (e.g., disease severity, drug usage). Requires consultations, expert-led studies, public comment, a 180-day work plan, annual reports to Congress, and "such sums as necessary" authorized (FY 2027–2031).
Significant Changes to Existing Law
- Harmonizes FDA protections (21 CFR Parts 50 and 56) with HHS research inclusion rules, potentially easing barriers to enrolling pregnant women while maintaining safety standards.
- Introduces new federal mandates for awareness campaigns and structured research funding prioritization at NICHD, which previously lacked such targeted processes for this population.
Potential Impacts
- Government Agencies: FDA and NIH/NICHD gain new rulemaking, planning, reporting, and funding duties; HHS/CDC involved in education efforts. Increases administrative workload but provides dedicated appropriations.
- Citizens: Pregnant and lactating women, along with their infants, could access better safety data on medications, reducing reliance on untested treatments. Providers and families benefit from improved awareness and trial access.
- International Relations: Minimal direct impact, though enhanced U.S. research could influence global standards on maternal drug studies.
Main Stakeholders Affected
- Pregnant and lactating women and families: Direct beneficiaries of safer drugs and easier trial access.
- Healthcare providers and medical societies: Gain resources for patient education and research participation.
- Researchers and NICHD networks: Receive prioritized funding and guidance.
- Pharmaceutical industry: Affected by harmonized regs and post-market surveillance emphasis.
- Advocacy organizations: Involved in consultations, especially those focused on high maternal mortality groups.
- Federal agencies: FDA, NIH, HHS, CDC bear implementation responsibilities.
Notable Legal, Constitutional, or Political Implications
- Legal: Strengthens ethical research frameworks by balancing protections with inclusion, without overriding existing safety laws. Mandates public comment and congressional oversight for transparency.
- Constitutional: No apparent challenges; aligns with federal authority over public health and interstate commerce.
- Political: Bipartisan sponsorship (introduced by Reps. Castor, Fitzpatrick, Underwood); emphasizes maternal health equity, potentially advancing related policy debates without controversy.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (2)
Rep. Fitzpatrick, Brian K. [R-PA-1], Rep. Underwood, Lauren [D-IL-14]
Recent Actions
- 2026-05-04: Referred to the House Committee on Energy and Commerce.
- 2026-05-04: Introduced in House
- 2026-05-04: Introduced in House
Bill Versions
- Advancing Safe Medications for Moms and Babies Act of 2026 — issued 2026-05-04 — PDF (9 pages)