Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
This bill extends federal funding through 2031 for research grants that give ALS patients access to investigational treatments. It strengthens oversight by requiring grant recipients to promptly report serious unexpected side effects and submit patient safety and effectiveness data when applying for grant renewals. It also makes combined phase 2 and 3 trials eligible for funding and requires the Food and Drug Administration to publish a five-year plan to advance treatments for rare neurodegenerative diseases.
What this bill touches.
Who it helps · who it burdens.
Who it helps
- ALS and neurodegenerative disease researchers and clinical trial sponsorsExtends federal grant funding authorizations for ALS and neurodegenerative disease research through 2031, and expands trial eligibility to include combined phase 2 and phase 3 clinical trials (Sec. 2, Sec. 3(c)).
Who it burdens
- ALS drug manufacturers and grant recipientsMust provide enrollment, safety, and efficacy data when applying for grant renewals and are required to promptly report unexpected, serious adverse events from phase 3 trials directly to the grant-making agency (Sec. 3(a), Sec. 3(b)).
- Food and Drug Administration (FDA)Must publish a five-year action plan for rare neurodegenerative diseases on its website within 18 months of enactment, followed by a progress report within five years (Sec. 4).
- Department of Health and Human ServicesMust request and assess patient enrollment, safety, and efficacy data from manufacturers or sponsors before renewing experimental ALS drug research grants (Sec. 3(a)).
The provisions, in plain language.
Extends funding authorizations for federal ALS research grants and related neurodegenerative disease programs through 2031.
Requires the Department of Health and Human Services to request and review patient enrollment, safety, and available efficacy data before approving grant renewals for experimental ALS drugs.
Requires grant recipients to promptly report any unexpected, serious adverse health events from phase 3 trials directly to the grant-making agency.
Expands grant eligibility to include combined phase 2 and phase 3 clinical trials that begin patient enrollment within a timeframe set by federal officials.
Requires the Food and Drug Administration to publish a five-year action plan for rare neurodegenerative diseases within 18 months, followed by a progress report within five years.