Sponsors (3)
The bill aims to expand inclusion of pregnant and lactating people in research and improve clinical guidance through aligned rules, outreach, and prioritized NIH funding—delivering better evidence and clinician support while creating new federal costs, administrative burdens, and risks that some groups or conditions may still be left behind.
Pregnant and lactating people will gain greater access to evidence and clinical trial opportunities because agency rules, outreach, and prioritized NIH funding are designed to increase inclusion and study of drugs used in pregnancy and lactation.
Clinicians and hospitals will get better, more timely guidance and targeted resources—improving counseling and prescribing for pregnant and lactating patients—through funded education and new peer‑reviewed study results.
Researchers and trial sponsors will face clearer, more consistent regulatory expectations across agencies, reducing compliance uncertainty and lowering administrative friction for pregnancy‑inclusive studies.
Taxpayers will face increased federal spending to support the education campaign and authorized research activities across FY2027–FY2031.
The process for prioritizing NIH studies could delay evidence for some drugs and, because feasibility and investigator availability are factors, may leave rare conditions or lower‑priority groups without timely studies.
A tight 180‑day rulemaking deadline risks rushed regulation that may omit full stakeholder input or create legal vulnerabilities during implementation.
Based on analysis of 4 sections of legislative text.
Harmonizes FDA/HHS human‑subjects rules, funds an education campaign, and directs NIH/NICHD to prioritize research on medications used by pregnant and lactating people.
Requires HHS (through FDA) to align human-subjects protections with HHS rules on inclusion of pregnant women in clinical research, launches a federally run education campaign about participation options for pregnant and lactating people, and directs NIH (via NICHD) to fund and prioritize research on drugs used during pregnancy and lactation. Provides multi-year authorized funding for education and allows NIH to receive necessary funds for priority research, with reporting and timelines for implementation.
Official title: To implement certain recommendations to promote the inclusion of pregnant and lactating women in clinical research, and for other purposes.
Introduced May 4, 2026 by Kathy Castor · Last progress May 4, 2026