What does Preamble of Advancing Safe Medications for Moms and Babies Act of 2026 do?

This bill, formally titled 'To implement certain recommendations to promote the inclusion of pregnant and lactating women in clinical research, and for other purposes,' aims to implement recommendations related to the inclusion of pregnant and lactating women in clinical research.

What does SHORT TITLE. of Advancing Safe Medications for Moms and Babies Act of 2026 do?

This bill is formally titled Advancing Safe Medications for Moms and Babies Act of 2026

What does UPDATING FDA REGULATIONS TO INCLUDE PREGNANT WOMEN IN CLINICAL of Advancing Safe Medications for Moms and Babies Act of 2026 do?

This section aims to facilitate compliance with federal regulations regarding the protection of pregnant women in research. It also seeks to promote the inclusion of pregnant women in clinical research. The Secretary of Health and Human Services, through the Commissioner of Food and Drugs, is directed to harmonize FDA regulations (including parts 50 and 56 of title 21, Code of Federal Regulations) with Department of Health and Human Services regulations regarding the inclusion of pregnant women in clinical research. The Secretary must finalize these regulations within 180 days of the Act's enactment.

What does RAISING AWARENESS OF RESEARCH THAT INCLUDES PREGNANT AND of Advancing Safe Medications for Moms and Babies Act of 2026 do?

The Secretary of Health and Human Services shall establish an education campaign on including pregnant and lactating women in clinical research. The campaign aims to educate patients, families, health care providers, and other target audiences on benefits and available resources. The Secretary shall consult with various organizations and representatives to carry out this section. A needs assessment and planning process will be conducted to identify target audiences and resource needs. Campaign materials will be published on a public website and regularly updated.

What does RESEARCH PRIORITIZATION PROCESS FOR PREGNANT AND LACTATING of Advancing Safe Medications for Moms and Babies Act of 2026 do?

This section directs the Director of the National Institutes of Health (NIH), through the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), to carry out priority research projects on drugs prescribed for pregnant and lactating women. The NIH Director must establish a research prioritization process to determine which projects receive priority funding. This prioritization process must consider factors such as unmet medical needs, research feasibility, and potential impact, including disease severity and treatment costs. The Director must seek feedback from NICHD research networks, relevant medical societies, and organizations with expertise in maternal and child health. Research projects must be conducted by experts and based on peer-reviewed scientific evidence. The Secretary must provide an opportunity for public comment on the program. The NIH Director must submit a work plan to specified congressional committees within 180 days of enactment. Annual reports detailing project funding, descriptions, and prioritization rationale must be submitted to congressional committees for five fiscal years. Appropriations are authorized for fiscal years 2027 through 2031 to carry out this section.

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Advancing Safe Medications for Moms and Babies Act of 2026

Last updated: 5/4/2026 · Introduced: 5/4/2026

Author: Kathy Castor (D-FL)

TL;DR (AI)

The Secretary of Health and Human Services is directed to harmonize FDA regulations with Department of Health and Human Services regulations regarding the inclusion of pregnant women in clinical research.
The Secretary of Health and Human Services shall establish an education campaign to educate patients, families, health care providers, and other target audiences on the benefits and available resources of including pregnant and lactating women in clinical research.
The Director of the National Institutes of Health shall carry out priority research projects on drugs prescribed for pregnant and lactating women, using a research prioritization process that considers factors such as unmet medical needs and potential impact.

119th Congressin committeeOfficial page

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Includes provisions on preamble, short title., and 3 more.

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