Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
What does the HR 8205 do?
HR 8205 is a House bill sponsored by Rep. Mike Quigley (D-IL-5). This bill extends the 2021 Accelerating Access to Critical Therapies for ALS Act — which authorizes HHS and FDA grants for expanded-access research on investigational drugs for amyotrophic lateral sclerosis and other rare neurodegenerative diseases — through fiscal year 2031. It also tightens the underlying grants program by requiring safety and efficacy data on renewals, mandating prompt adverse-event reporting, expanding the "phase 3" definition to cover phase 2/3 combined trials, and requiring FDA to publish a new 5-year rare-neurodegenerative-disease action plan and follow-up report. Extends the ALS investigational-drug grant program and its $100M-per-year authorization through fiscal year 2031, and adds safety-reporting and renewal-review requirements.
Did HR 8205 pass? Where it stands
As of July 29, 2026, HR 8205 has passed the House.
Status: Passed House
Latest vote: House Passed by voice vote on July 22, 2026
Outlook: Likely
Key provisions
- What the Underlying Program Does
- HHS awards grants to small-business drug sponsors running expanded-access programs for people with ALS not eligible for clinical trials
- FDA-NIH Public-Private Partnership advances rare neurodegenerative disease research
- Authorized at $100M per year since fiscal year 2022
- What This Bill Extends
- Extends the $100M-per-year authorization of appropriations through fiscal year 2031
- Extends the grants program sunset from September 30, 2026 to September 30, 2031
- New Grant-Program Guardrails
- Grant renewals must include HHS review of enrollment, safety, and any available efficacy data
- Grantees must promptly report new and serious adverse events and unexpected safety information
- "Phase 3" now includes phase 2/3 combined trials that begin enrollment within a Secretary-set timeframe
- FDA Action Plan Refresh
- FDA must publish a new 5-year rare-neurodegenerative-disease action plan within 18 months of enactment
- FDA must publish a report on actions taken within 5 years of enactment
Last updated July 29, 2026