Advancing Safe Medications for Moms and Babies Act of 2026

This legislation seeks to facilitate the inclusion of pregnant and lactating women in clinical research by requiring the Secretary of Health and Human Services, through the Food and Drug Administration, to harmonize existing regulations related to human subject protection for pregnant women within 180 days of enactment. Concurrently, it mandates the establishment of an education campaign , in consultation with federal agencies and expert organizations, to inform patients, families, and healthcare providers about the benefits of including these populations in clinical research. The campaign will also highlight available registries and clinical trials, and guide women on how to easily identify and enroll in such studies. To further advance this goal, the bill directs the Director of the National Institutes of Health, via the Eunice Kennedy Shriver National Institute of Child Health and Human Development, to implement a research prioritization process for projects on drugs prescribed to pregnant and lactating women. This process will consider factors such as unmet medical need, research feasibility, and potential impact, and will involve feedback from relevant research networks and medical societies. The NIH Director must submit a work plan and annual reports to Congress on these research efforts. The bill authorizes specific appropriations for the education campaign and necessary sums for the research prioritization from fiscal years 2027 through 2031.