Summary
Updates rules and funds research to safely include pregnant and nursing women in clinical trials to learn more about how medicines affect them and their babies.
What problem does this solve?
Pregnant and nursing women are often excluded from medical research, leaving doctors and patients with little information on medication safety for them or their babies. This bill changes federal rules to encourage their inclusion, creates an education campaign, and funds new research to fill this knowledge gap.
What does this bill do?
Updates FDA rules for clinical trials
Requires the Food and Drug Administration (FDA) to change its rules to make it easier and clearer to include pregnant women in clinical research studies.
Creates a public education campaign
Starts a national campaign to teach patients, families, and doctors about the benefits of including pregnant and nursing women in research and how to join studies.
Funds new research on medications
Directs the National Institutes of Health (NIH) to fund and prioritize research projects on new and existing drugs used by pregnant and nursing women.
Authorizes funding for education
Approves $5 million per year from 2027 to 2031 to fund the public education campaign about clinical trials for pregnant and nursing women.
Requires reports to Congress
Mandates that the National Institutes of Health (NIH) submit a work plan and annual reports to Congress detailing the research projects funded and their progress.
Who does this affect?
- Pregnant and lactating women
- Infants and children
- Healthcare providers
What is the real world impact?
•
Improves medication safety for mothers and babies
Gathers crucial data on how drugs affect pregnant and nursing women, which is currently lacking. This helps doctors make safer and more effective treatment decisions for them and their infants.
•
Balances research benefits with potential risks
Including pregnant women in clinical trials introduces risks to both the mother and the developing fetus. Critics may worry that the push for more data could lead to ethical challenges or unforeseen harm if a new drug has negative effects.
When does this start?
This bill sets multiple deadlines for federal agencies to complete specific actions after it becomes law.
FDA regulation update
The Secretary of Health and Human Services must finalize new rules for including pregnant women in clinical trials within 180 days of the bill becoming law.
NIH research work plan
The National Institutes of Health must submit a work plan for its research projects to Congress within 180 days of the bill becoming law.
Annual NIH progress reports
The National Institutes of Health must report to Congress on its research program by October 1st each year for five years after the bill becomes law.
Education campaign funding
Authorizes funding for the public education campaign for the fiscal years 2027 through 2031.