Advancing Safe Medications for Moms and Babies Act of 2026
- Sponsor
- Rep. Castor, Kathy [D-FL-14]
- Committees
- Energy and Commerce Committee (primary)
- Last action
- May 4, 2026
Bottom line
This bill aims to improve maternal and infant health outcomes by promoting the inclusion of pregnant and lactating women in clinical research and disseminating information about safe medication use.
What it actually does
The bill directs the Food and Drug Administration (FDA) to harmonize its regulations to facilitate the inclusion of pregnant women in clinical research. It also mandates the Secretary of Health and Human Services to establish a public education campaign to raise awareness about research involving pregnant and lactating women. Furthermore, the bill requires the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to prioritize and conduct research on drugs used by these populations.
Proponents argue
Proponents argue that the historical exclusion of pregnant and lactating women from clinical trials has created a significant knowledge gap, forcing healthcare providers to make treatment decisions without adequate data, potentially endangering mothers and infants. They contend this bill will lead to safer, more effective medication use for these populations by generating crucial evidence, raising awareness, and fostering targeted research, ultimately improving health outcomes and reducing maternal and infant morbidity and mortality.
Opponents contend
While direct opposition to the bill's core goals is unlikely, potential concerns might revolve around the practical challenges and ethical complexities of conducting research on vulnerable populations. Critics might argue that the bill's timelines for regulatory harmonization are ambitious, or that the authorized appropriations might be insufficient to achieve the stated goals comprehensively, leading to underfunded mandates or diluted impact.
The bill is concise and clearly written, allowing for a quick read and easy understanding of its core provisions.
Section 2
Updating FDA Regulations to Include Pregnant Women in Clinical Trials
This section requires the Secretary of Health and Human Services, through the FDA Commissioner, to update and align its regulations concerning the protection of human subjects in clinical research, specifically parts 50 and 56 of title 21, Code of Federal Regulations. The goal is to harmonize these rules with broader HHS regulations to promote and facilitate the inclusion of pregnant women in clinical research, with a deadline of 180 days after enactment.
Supporters argue
Supporters argue that harmonizing regulations will remove existing barriers and ambiguities that have historically discouraged the inclusion of pregnant women in clinical trials, leading to a critical lack of data on drug safety and efficacy for this population. This provision is seen as a crucial first step to ensure that pregnant women receive evidence-based medical care.
Critics contend
No specific opposition is typically raised against this provision, as the goal of regulatory clarity and improved evidence for pregnant women is widely supported. However, some might express concerns about the administrative burden on the FDA to meet the 180-day deadline, or the potential for unintended consequences if harmonization is not carefully managed.
Tradeoffs
The tension lies between the ethical imperative to protect vulnerable populations (like pregnant women) from research risks and the ethical imperative to ensure they have access to evidence-based medical treatments, which requires their inclusion in research. This provision attempts to balance these by facilitating inclusion while maintaining protections.
Section 3
Raising Awareness of Research That Includes Pregnant and Lactating Women
This section directs the Secretary of HHS, in consultation with the CDC and NIH, to create and implement an education campaign. The campaign will inform patients, families, and healthcare providers about the benefits of including pregnant and lactating women in clinical research, available registries and trials, the role of postmarket surveillance, and how to identify and enroll in such studies. It also authorizes $5 million annually for fiscal years 2027 through 2031 for this purpose.
Section 4
Research Prioritization Process for Pregnant and Lactating Women at the Eunice Kennedy Shriver National Institute of Child Health and Human Development
This section directs the NIH, through NICHD, to conduct priority research on existing and new drugs for pregnant and lactating women. It establishes a formal prioritization process based on factors like unmet medical need, research feasibility, and potential impact. The NICHD Director must consult with experts, ensure rigorous research, and provide annual reports to Congress on projects and expenditures. It authorizes "such sums as may be necessary" for fiscal years 2027 through 2031.