Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

Key Points

• This bill extends the Accelerating Access to Critical Therapies for ALS Act through fiscal year 2031, ensuring that federal support for ALS research grants and treatment access programs continues for five more years beyond the current 2026 expiration.
• The bill adds a new requirement for the government to review how many patients are actually enrolling in clinical trials when deciding whether to renew research grants. Drug manufacturers would also need to share interim trial data with federal officials.
• The definition of qualifying clinical trials is broadened to include combined phase 2/3 trials and planned phase 3 trials that have not yet started enrolling patients, which could let more experimental drugs qualify for support earlier in their development.
• The FDA must publish a new five-year action plan for ALS and other rare brain and nervous system diseases within one year, and must also report on what was accomplished under its 2022 action plan, including how well it served diseases beyond ALS.
• A Government Accountability Office report is required within four years to evaluate the program's effectiveness, providing Congress with data to inform future decisions about ALS research funding.