Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
Latest action (3 Nov 2026): Became Public Law No: 119-138.
What this bill does
H.R. 8205 would extend the Accelerating Access to Critical Therapies for ALS Act, which funds grants supporting research into treatments for amyotrophic lateral sclerosis (ALS), through fiscal year 2031. It also makes several adjustments to how the grant program operates: when reviewing renewal applications for grants tied to an investigational drug, the Secretary of Health and Human Services would be required to request and review enrollment, safety, and available efficacy data; grant recipients would be required to promptly report serious, unexpected adverse events in phase 3 trials; and the definition of a "phase 3" trial would be clarified to include certain combined phase 2/3 trials. The bill also directs the FDA Commissioner to publish an action plan within 18 months addressing rare neurodegenerative disease initiatives, followed by a report after five years assessing progress.
The bill primarily affects the FDA, grant-making institutions, and pharmaceutical companies or researchers developing ALS therapies, as well as patients and advocacy groups who rely on continued federal support for ALS research. By extending funding authority and adding reporting requirements, it aims to keep research grants flowing while improving oversight of safety and progress data.
The bill passed the House on July 22, 2026, by voice vote under a suspension of the rules, indicating broad bipartisan support. It now moves to the Senate for consideration; it would need Senate passage and the President's signature to become law.
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 act 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 act 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 NIH, in considering renewal of its grants, must assess available information on the safety and efficacy of the investigational drugs. It must also require grantees to promptly report serious and unexpected adverse events associated with their investigational drugs.
Additionally, 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, that treat ALS and other rare neurodegenerative diseases. The FDA must also publish a report describing the actions it has taken under the plan.
Timeline
3 Nov 2026
Became Public Law No: 119-138.
Common questions
- What does H.R. 8205 do?
- H.R. 8205 would extend the Accelerating Access to Critical Therapies for ALS Act, which funds grants supporting research into treatments for amyotrophic lateral sclerosis (ALS), through fiscal year 2031. It also makes several adjustments to how the grant program operates: when reviewing renewal applications for grants tied to an investigational drug, the Secretary of Health and Human Services would be required to request and review enrollment, safety, and available efficacy data; grant recipients would be required to promptly report serious, unexpected adverse events in phase 3 trials; and the definition of a "phase 3" trial would be clarified to include certain combined phase 2/3 trials. The bill also directs the FDA Commissioner to publish an action plan within 18 months addressing rare neurodegenerative disease initiatives, followed by a report after five years assessing progress. The bill primarily affects the FDA, grant-making institutions, and pharmaceutical companies or researchers developing ALS therapies, as well as patients and advocacy groups who rely on continued federal support for ALS research. By extending funding authority and adding reporting requirements, it aims to keep research grants flowing while improving oversight of safety and progress data. The bill passed the House on July 22, 2026, by voice vote under a suspension of the rules, indicating broad bipartisan support. It now moves to the Senate for consideration; it would need Senate passage and the President's signature to become law.
- Has H.R. 8205 become law?
- Yes. H.R. 8205 has been enacted. Status last updated 3 Nov 2026.
- Who sponsored H.R. 8205?
- H.R. 8205 was sponsored by Rep. Quigley, Mike [D-IL-5] (D-IL), with 103 cosponsors.
- What's the latest action on H.R. 8205?
- Became Public Law No: 119-138. (3 Nov 2026).
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