Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

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.

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