Advancing Safe Medications for Moms and Babies Act of 2023

Advancing Safe Medications for Moms and Babies Act of 2023

This bill establishes programs and requirements to support the inclusion of pregnant and lactating women in clinical research.

For example, the bill requires the Department of Health and Human Services to align the Food and Drug Administration's regulations for human subjects in clinical trials with other departmental regulations for pregnant women in clinical research.

The bill also establishes (1) a national online clearinghouse with information about clinical trials that enroll pregnant and lactating women, (2) an advisory committee to help coordinate federal activities with respect to clinical research for pregnant and lactating women, and (3) an educational campaign on the importance of including pregnant and lactating women in clinical research.

The National Institutes of Health must also prioritize certain research projects on new and existing medications for pregnant and lactating women based on need, feasibility, and the potential impact of the research.