This bill directs federal health agencies to increase research and awareness about medicines used by pregnant and lactating women. It requires the Food and Drug Administration to update and harmonize its human subject protections rules to support including pregnant women in clinical trials and to finalize those regulations within 180 days of the bill becoming law. The Department of Health and Human Services must run an education campaign, with help from agencies like the CDC and NIH, to tell patients, families, and health care providers about clinical trials, registries, and how to join them. The campaign must publish and update materials on a public website and has $5,000,000 authorized per year for fiscal years 2027–2031. The National Institute of Child Health and Human Development (NICHD) must carry out priority research projects on drugs used by pregnant and lactating women and create a process to decide which projects get priority. That process must consider available evidence, feasibility, and potential impact. NICHD must seek input from research networks, medical societies, and community organizations, allow public comment, submit a work plan within 180 days, and file annual reports each October 1 for five years about funded projects. The bill authorizes additional appropriations for NICHD research as "such sums as may be necessary" for fiscal years 2027–2031.
The bill's stated goals are to facilitate compliance with protections for pregnant research participants, promote their inclusion in clinical research, increase public and provider awareness about trials and registries, and fund prioritized research to close gaps in knowledge about drugs used during pregnancy and lactation.
No publicly available information.