H.R. 8205 · Passed both chambers · Health

Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

Sponsor: Mike Quigley (D-IL)

What it does

• Reauthorize NIH grants through FY2031 for research on investigational drugs to prevent or treat ALS for individuals not eligible for clinical trials.
• Reauthorize FDA grants through FY2031 for research and development of therapies to prevent and treat ALS and other neurodegenerative diseases.
• Require NIH to assess safety and efficacy information when renewing grants and require grantees to promptly report serious and unexpected adverse events.
• Require FDA to publish a five-year plan describing actions to foster development and facilitate access to investigational drugs for ALS and rare neurodegenerative diseases, and later publish a report on actions taken und

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 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…

Latest action

Sep 28, 2026: Passed Senate without amendment by Voice Vote. (consideration: CR S5120)

Committee: House Energy and Commerce