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H.R. 8651 (119th Congress)Committee
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Advancing Safe Medications for Moms and Babies Act of 2026

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The Advancing Safe Medications for Moms and Babies Act of 2026 directs the FDA to harmonize its clinical trial regulations to facilitate the inclusion of pregnant women in drug research studies. The bill requires the FDA to finalize updated regulations within 180 days and establishes a public education campaign to inform patients, healthcare providers, and families about clinical trials and registries involving pregnant and lactating women. Additionally, it directs the National Institutes of Health to establish a research prioritization process and fund studies on existing and new drugs used by pregnant and lactating women.

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