Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
Summary
What This Bill Does
The Senate-passed Accelerating Access to Critical Therapies for ALS Reauthorization Act extends the underlying Act and expanded-access grant authorization through 2031. It formally labels the research awards as expanded-access grants and revises applications to explain how generated data will support ALS research or development and to assure prompt reporting of available safety data from ongoing trials. For renewal applications, HHS must request from the investigational-new-drug sponsor and assess enrollment, safety, and available efficacy data. A phase 3 clinical trial includes combined phase 2/3 trials and planned phase 3 trials not yet enrolling; a related grant condition allows HHS to set the timeframe for enrollment. FDA must develop or update its rare-neurodegenerative-disease action plan within one year and every five years thereafter. Each later plan must describe implementation of the prior plan, additional planned actions, implementation barriers, recommendations, and potentially resource estimates. The existing GAO report is reset relative to the 2026 reauthorization, and HHS must report within four years on the effectiveness of activities under sections 2, 3, and 5 without duplicating the FDA plan. The bill also corrects two statutory drafting errors. Compared with the introduced text, the Senate version broadens grant applications and safety reporting, replaces a one-time updated plan with recurring five-year plans, and supplements independent GAO oversight with a separate HHS effectiveness report.
Who Benefits and How
People living with ALS, expanded-access participants, and their families benefit from program continuation through 2031, clearer use of grant-generated evidence, prompt safety-data reporting, and renewal review of enrollment, safety, and available efficacy. ALS researchers and qualifying access programs retain federal funding opportunities. FDA, HHS, Congress, and rare-neurodegenerative-disease communities gain recurring public plans, implementation-barrier analysis, resource estimates, a GAO report, and an HHS effectiveness assessment. Therapy sponsors may benefit from clearer grant terminology and clinical-trial eligibility, including planned phase 3 trials.
Who Bears the Burden and How
Expanded-access grant applicants must describe research use of data and promptly report ongoing-trial safety data. Investigational-new-drug sponsors must supply enrollment, safety, and available efficacy information for renewal review, and grantees must meet HHS-set enrollment timeframes. HHS must administer extended grants, assess renewal evidence, define enrollment timing, and prepare a four-year effectiveness report. FDA must update its action plan every five years and disclose implementation barriers. GAO must complete the reset review, and federal taxpayers bear continued program costs through 2031.
Key Provisions
- Extends ALS therapy-access authorities and expanded-access grant funding through 2031.
- Requires grant applications to explain research use of data and promptly report available safety data.
- Requires renewal review of enrollment, safety, and available efficacy data.
- Expands phase 3 eligibility to combined phase 2/3 and planned phase 3 trials under grant timing rules.
- Requires FDA action-plan updates within one year and every five years thereafter.
- Requires GAO and HHS reports on program performance and effectiveness.
- Corrects statutory references and drafting errors in the underlying Act.
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
Reauthorizes ALS therapy-access programs through 2031, strengthens expanded-access grant data and safety requirements, establishes recurring FDA action plans, and adds independent and departmental effectiveness reports.
Key Policy Areas
Healthcare, Medical Research, Drug Regulation
Primary Purpose
Reauthorizes ALS therapy-access programs through 2031, strengthens expanded-access grant data and safety requirements, establishes recurring FDA action plans, and adds independent and departmental effectiveness reports.
Policy Domains
Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
Identified Gains
- People living with amyotrophic lateral sclerosis
- ALS expanded-access participants
- ALS therapy researchers
- Expanded-access grant recipients
- Rare neurodegenerative disease communities
- Congressional health committees
Identified Costs
- Investigational ALS drug sponsors
- Expanded-access grant applicants
- Health and Human Services grant reviewers
- Food and Drug Administration planning staff
- Government Accountability Office analysts
- Federal taxpayers
Sponsors
Legislative Progress
Passed SenateHeld at the desk.
Received in the House.
Message on Senate action sent to the House.
Passed Senate with an amendment by Voice Vote. (consideration: CR …
Passed/agreed to in Senate: Passed Senate with an amendment by …
Placed on Senate Legislative Calendar under General Orders. Calendar No. …
Committee on Health, Education, Labor, and Pensions. Reported by Senator …
Reported by Mr. Cassidy, with an amendment
Committee on Health, Education, Labor, and Pensions. Ordered to be …
Read twice and referred to the Committee on Health, Education, …
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Congressional health committees, FDA grant-renewal reviewers for ALS therapies, FDA rare-neurodegenerative-disease program staff
Congressional health committees, Food and Drug Administration planning staff, Government Accountability Office analysts, Health and Human Services grant reviewers face effects in multiple directions
ALS expanded-access programs, ALS program grant recipients, ALS research grant recipients
Rare-disease therapy developers faces effects in multiple directions
Positive-direction: ALS expanded-access programs, ALS therapy researchers, Investigational ALS drug manufacturers, Planned phase 3 trial sponsors
Negative-direction: ALS program grant recipients, ALS research grant recipients, Expanded-access grant recipients, Investigational ALS drug sponsors
ALS expanded-access participants, People living with amyotrophic lateral sclerosis, Rare neurodegenerative disease communities
ALS expanded-access participants, People living with amyotrophic lateral sclerosis, Rare neurodegenerative disease communities face effects in multiple directions
ALS research compliance counsel, Legislative compliance counsel
ALS investigational-drug manufacturers, ALS therapy developers with phase 2/3 trials
Positive-direction: ALS therapy developers with phase 2/3 trials
Negative-direction: ALS investigational-drug manufacturers
ALS patient advocacy organizations, Rare neurodegenerative disease patient communities outside ALS
Congressional health-oversight staff, Government Accountability Office health-program reviewers
Positive-direction: Congressional health-oversight staff
Negative-direction: Government Accountability Office health-program reviewers
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "patients"
- → People living with amyotrophic lateral sclerosis
- "grant_lead"
- → Secretary of Health and Human Services
- "data_providers"
- → Investigational ALS drug sponsors
- "regulatory_lead"
- → Commissioner of Food and Drugs
- "grant_recipients"
- → ALS expanded-access research entities
- "independent_auditor"
- → Comptroller General of the United States
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology