Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
Latest action (4 Aug 2026): Passed Senate with an amendment by Voice Vote.
What this bill does
S. 4472, the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, would extend and update an existing federal program supporting research into treatments for amyotrophic lateral sclerosis (ALS). It reauthorizes the underlying 2021 law's programs and funding through fiscal year 2031 (previously set to expire after 2026). It also revises the FDA's expanded-access grant program for ALS drug developers—clarifying application and reporting requirements, adding a requirement that grant recipients promptly report safety data from ongoing clinical trials, and expanding the definition of "phase 3 clinical trial" to include combined phase 2/3 trials and planned-but-not-yet-enrolling trials. The bill further directs FDA to periodically update (not just issue once) its action plan for ALS and other rare neurodegenerative diseases, and adds a new HHS reporting requirement to Congress assessing the program's effectiveness. Minor technical corrections to statutory text are also made.
The bill primarily affects the FDA, drug sponsors pursuing ALS treatments, and patients seeking expanded access to investigational ALS therapies, by keeping the program's grant and reporting infrastructure operating for several more years and tightening its data and safety reporting.
The bill passed the Senate by voice vote on August 4, 2026, with an amendment. It now goes to the House of Representatives, which must pass it (potentially with further changes) before it could go to the President for signature.
Plain-English summary generated by Bill100 AI from the official record. Always verify against the source below.
Official summary
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.
Timeline
4 Aug 2026
Passed Senate with an amendment by Voice Vote.
17 Jun 2026
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Common questions
- What does S. 4472 do?
- S. 4472, the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, would extend and update an existing federal program supporting research into treatments for amyotrophic lateral sclerosis (ALS). It reauthorizes the underlying 2021 law's programs and funding through fiscal year 2031 (previously set to expire after 2026). It also revises the FDA's expanded-access grant program for ALS drug developers—clarifying application and reporting requirements, adding a requirement that grant recipients promptly report safety data from ongoing clinical trials, and expanding the definition of "phase 3 clinical trial" to include combined phase 2/3 trials and planned-but-not-yet-enrolling trials. The bill further directs FDA to periodically update (not just issue once) its action plan for ALS and other rare neurodegenerative diseases, and adds a new HHS reporting requirement to Congress assessing the program's effectiveness. Minor technical corrections to statutory text are also made. The bill primarily affects the FDA, drug sponsors pursuing ALS treatments, and patients seeking expanded access to investigational ALS therapies, by keeping the program's grant and reporting infrastructure operating for several more years and tightening its data and safety reporting. The bill passed the Senate by voice vote on August 4, 2026, with an amendment. It now goes to the House of Representatives, which must pass it (potentially with further changes) before it could go to the President for signature.
- Has S. 4472 become law?
- Not yet. As of 4 Aug 2026, S. 4472 is passed senate (house next).
- Who sponsored S. 4472?
- S. 4472 was sponsored by Sen. Lisa Murkowski [R-AK] (Republican-AK), with 15 cosponsors.
- What's the latest action on S. 4472?
- Passed Senate with an amendment by Voice Vote. (4 Aug 2026).
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