Newborn Screening Saves Lives Reauthorization Act of 2025
Newborn Screening Saves Lives Reauthorization Act of 2025 (H.R. 4709) would reauthorize and expand key federal activities under the Public Health Service Act related to genetic diseases and newborn screening. Primarily, it aims to strengthen the system for screening newborns, following up with families, and providing ongoing care for individuals with heritable disorders. The bill would increase funding authorizations, broaden education and outreach to parents and advocates, improve data collection and surveillance, and enhance oversight and transparency around the screening process and the use of genetic testing in newborns and children. It also updates provisions governing research using newborn genetic material (like dried blood spots) and expands recommendations for ensuring ethical practices. Overall, the bill seeks to modernize and scale up newborn screening programs through better education, data integration, test development, follow-up, and research ethics, with a long-range focus through 2030.
Key Points
- 1Strengthened information and outreach to families and patient groups about screening, follow-up, treatment, and long-term care, with an emphasis on delivering materials at appropriate literacy levels and re-engaging individuals who did not receive recommended follow-up services.
- 2Expanded duties for the Advisory Committee on Heritable Disorders in Newborns and Children, including: publishing consumer-friendly explanations of the screening panel nomination process and data needs; clarifying how to obtain technical assistance and when assistance could create conflicts of interest; and adding guidance on the appropriate use of safe and effective genetic testing in newborns and children.
- 3Enhanced laboratory surveillance and data sharing, including: developing new screening tests; improving data analysis, interpretation, and harmonization; and coordinating real-time surveillance from screening through diagnosis and long-term care, with linkages to state birth defects and developmental disabilities surveillance programs to help families access services.
- 4New requirements for the Hunter Kelly Research Program to emphasize piloting reliable newborn screening technologies and to require practical coordination with state health departments.
- 5Substantially updated funding authorizations for newborn screening programs, increasing annual appropriations and aligning them to future years (2026 and 2030), signaling a larger federal investment in national and state newborn screening activities.
- 6Ethics and research oversight: retooling Institutional Review Board (IRB) guidance to treat research on nonidentified newborn dried blood spots as a form of secondary research under existing federal rules, potentially easing certain federally funded research involving de-identified samples.