Sponsors (3)
The bill aims to expand and accelerate pregnancy- and lactation-inclusive research, education, and transparency—improving evidence and clinician guidance for pregnant people—while imposing modest federal costs and risks of rushed or uneven implementation that could limit benefits for some populations.
Pregnant and lactating people (and patients with chronic conditions treated during pregnancy) will get more and faster evidence about drug safety and effectiveness because agency rules, outreach, and NIH-funded prioritized studies are designed to increase their inclusion in trials and registries.
Researchers and trial sponsors will face clearer, more consistent regulatory requirements across agencies, reducing compliance uncertainty and administrative burden for clinical research involving pregnancy.
Pregnant and lactating people, their families, and healthcare providers will have increased awareness and easier access to information about eligible clinical trials through a sustained national education campaign and a centralized public website, and providers will receive targeted messaging and resources to support counseling.
The NIH prioritization process could delay studies of some drugs/conditions because resources and attention may be focused on higher‑priority areas, leaving some pregnant or lactating patients without timely evidence.
A tight 180‑day deadline to harmonize agency rules may force rushed rulemaking, increasing the risk of insufficient stakeholder input, implementation problems, or legal challenges.
Phrases limiting changes “to the extent practicable and consistent with other Federal statutory law” may constrain the scope of reforms, slowing meaningful expansion of inclusion for pregnant people.
Based on analysis of 4 sections of legislative text.
Harmonizes federal human-subjects rules, funds an education campaign, and directs NIH to prioritize research on drugs used by pregnant and lactating women.
Introduced May 4, 2026 by Kathy Castor · Last progress May 4, 2026
Requires the Department of Health and Human Services to align FDA human-subjects rules with HHS policies to make it easier to include pregnant and lactating women in clinical research; creates a federal education campaign to inform patients, families, and providers about research and registries; and directs NIH (through NICHD) to fund and prioritize studies on drugs used during pregnancy and lactation. Deadlines and reporting requirements are set for agency actions, and limited multi-year funding is authorized for the education campaign and NIH research activities.