H.R. 8651: Advancing Safe Medications for Moms and Babies Act of 2026

This bill, titled the Advancing Safe Medications for Moms and Babies Act of 2026, aims to improve the inclusion of pregnant and breastfeeding women in clinical research. It sets forth several key actions to enhance the understanding of how medications affect this demographic and to promote their health and safety during clinical trials.

Updating FDA Regulations

The bill mandates the Secretary of Health and Human Services, through the Commissioner of Food and Drugs, to revise existing regulations to ensure pregnant women are adequately protected while participating in clinical research. This involves:

• Facilitating compliance with federal regulations protecting the rights and well-being of pregnant women in research.
• Promoting greater inclusion of pregnant women in clinical studies.

Additionally, the updated regulations must be finalized within 180 days after the bill's enactment.

Raising Awareness

The Secretary, in collaboration with other federal agencies like the CDC and NIH, is required to establish an educational campaign to:

• Inform about the benefits of including pregnant and breastfeeding women in clinical research.
• Provide information about available clinical trials and registries suitable for these groups.
• Highlight the role of registries in post-market drug surveillance.
• Facilitate how pregnant women can find and participate in clinical trials.

This campaign will also involve a needs assessment to identify existing resources, barriers to awareness, and best practices to reach target audiences. A budget of $5 million per fiscal year from 2027 to 2031 is authorized to support this initiative.

Research Prioritization

The bill outlines a framework for prioritizing research on drugs for pregnant and breastfeeding women, specifically under the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Key components include:

• Identifying and funding priority research projects related to medications used by these women.
• Establishing a research prioritization process based on factors like unmet medical needs and research feasibility.
• Engaging with existing research networks and relevant medical experts to gather feedback in developing this prioritization process.

The findings from these projects must be peer-reviewed to ensure scientific rigor.

Accountability and Reporting

The Director of the NIH is tasked with creating a work plan to fund the priority research projects and report on progress annually for five years following the bill's enactment. Reports will include financial details and justifications for research prioritization.

Authorization of Appropriations

The bill permits necessary appropriations for carrying out various initiatives related to the research prioritization process and the awareness campaign for fiscal years 2027 through 2031.

Relevant Companies

• PFE (Pfizer Inc.): As a major pharmaceutical company, Pfizer may need to adjust its clinical trial processes to increase participation of pregnant and lactating women in studies for medications.
• NVS (Novartis AG): Similar to Pfizer, Novartis may be impacted in terms of developing new drugs specifically tested on pregnant and lactating women, as indicated by the focus of this bill.
• BMY (Bristol-Myers Squibb Company): This company may see a push to include more focused research on how their medications affect pregnant and lactating women, aligning with new regulatory requirements set forth by the bill.