Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 (S. 4472)

Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

This bill reauthorizes through FY2031 and revises programs that support research and development of drugs and other therapies to address amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease) and other neurodegenerative diseases.

The bill reauthorizes

• grants from the National Institutes of Health (NIH) for scientific research on investigational drugs to prevent or treat ALS for individuals not otherwise eligible for clinical trials,
• grants from the Food and Drug Administration (FDA) for research and development of therapies to prevent and treat ALS and other neurodegenerative diseases, and
• a Public-Private Partnership including the FDA and NIH that supports development and regulatory review of treatments for neurodegenerative diseases. 

Also, the bill revises the NIH grants to require (1) the NIH, in considering grant renewal, to assess available information on the safety and efficacy of the investigational drugs; (2) grantees to promptly report available safety data from ongoing clinical trials; and (3) the NIH to determine the timeframe for enrollment in clinical trials for the investigational drugs.

Additionally, every five years, the FDA must publish a plan describing actions it will take over a five-year period to foster development of safe and effective drugs, and facilitate access to investigational drugs, for ALS and other rare neurodegenerative diseases. Each plan must include the FDA's previous actions and recommendations for improvements.

Finally, the Government Accountability Office and the Department of Health and Human Services must report on the impacts of these grants.