“To implement certain recommendations to promote the inclusion of pregnant and lactating women in clinical research, and for other purposes.”
No CRS summary available for this bill.
This section directs the Secretary of Health and Human Services, acting through the FDA Commissioner, to issue regulations harmonizing FDA human subject protection regulations (21 CFR parts 50 and 56) with HHS regulations relating to the inclusion of pregnant women as subjects in clinical research, to facilitate compliance with applicable protections and promote such inclusion. The Secretary must finalize the regulations not later than 180 days after the date of enactment.
This section directs the Secretary of Health and Human Services (HHS), in consultation with the Directors of the Centers for Disease Control and Prevention and National Institutes of Health and other relevant agencies, to establish and implement an education campaign to inform patients, families, health care providers, and other audiences about (1) benefits of including pregnant and lactating women in clinical research for maternal and infant health; (2) available registries and clinical trials enrolling such women; (3) the role of registries and postmarket surveillance in studying drugs used by pregnant and lactating women; and (4) how to identify and enroll in such trials or registries. In developing the campaign, HHS must consult with women's and infants' health organizations (including those serving high maternal mortality/morbidity populations), medical societies, industry, and others; conduct a needs assessment evaluating existing resources, barriers, target audiences, best practices, and messaging strategies; and disseminate materials via a public website with a user-friendly interface listing relevant trials and registries. The section authorizes $5 million for FY2027 through FY2031.
This section directs the National Institutes of Health (NIH) Director, acting through the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), to carry out priority research projects on existing and new drugs prescribed for pregnant and lactating women and to establish a research prioritization process. The process must consider (1) available evidence of unmet medical needs or scientific gaps, (2) research feasibility including disease prevalence and investigator expertise, and (3) potential impact including disease severity, treatment costs, drug use frequency, and alternative treatments. In developing the process, NIH must consult NICHD research networks, relevant medical societies, and organizations focused on the health of pregnant and lactating women and children (including those representing high maternal mortality populations); ensure projects are conducted by experts using peer-reviewed evidence; and provide for public comment. For accountability, NIH must submit to specified congressional committees (1) a work plan within 180 days of enactment covering funding and process development and (2) annual reports for the five fiscal years after enactment detailing prior-year funding, project descriptions, and prioritization rationales. The section authorizes appropriations of such sums as necessary for FY2027 through FY2031.