Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
Summary
What This Bill Does
The House-passed Accelerating Access to Critical Therapies for ALS Reauthorization Act extends both the underlying Act and its ALS research-grant authorization from 2026 through 2031. When HHS reviews renewal applications for grants involving an investigational ALS drug, it must request from the manufacturer or sponsor and assess enrollment, safety, and any available efficacy data concerning prevention, diagnosis, mitigation, treatment, or cure. Grant applicants must promise to promptly report new and serious adverse events and unexpected safety information to the grant-making institution in addition to existing FDA investigational-drug reporting. For grant purposes, phase 3 includes a combined phase 2/3 trial that begins enrollment within a timeframe set by HHS through grant terms. Within 18 months, FDA must publish a five-year rare-neurodegenerative-disease action plan covering program enhancements, policy development, regulatory science, and other initiatives already described in the underlying law. Within five years of enactment, FDA must publish a report describing actions taken and whether the plan met those requirements. Compared with the introduced bill, the House text removes the House committee's nonbinding endorsement of direct appropriations, removes the four-year GAO report, changes the grant-renewal review from enrollment status and interim-data requests to enrollment, safety, and available-efficacy review, adds serious unexpected adverse-event reporting, narrows the combined-trial definition, and replaces a one-year retrospective action-plan report with an 18-month prospective plan and a five-year implementation report.
Who Benefits and How
People living with ALS and their families benefit from continuation of federal therapy-access and research authorities through 2031, closer review of enrollment and efficacy, and prompt escalation of serious unexpected safety information. Researchers and qualifying expanded-access programs retain federal grant opportunities. FDA, HHS grant reviewers, clinicians, and rare-neurodegenerative-disease communities gain structured safety and efficacy information and a public five-year action plan. Congress and the public gain an implementation report, though the House text provides less independent GAO oversight than the introduced bill.
Who Bears the Burden and How
Investigational-drug manufacturers and sponsors must supply enrollment, safety, and available efficacy data when HHS reviews a renewal. Grant applicants must promptly report new serious and unexpected safety information to the grant-making institution as well as satisfy existing FDA reporting rules. HHS grant staff must request and assess clinical data and set enrollment timeframes for combined phase 2/3 trials. FDA must prepare, publish, implement, and evaluate a five-year action plan. Federal taxpayers remain exposed to program costs through 2031, but the final bill removes the direct-appropriation endorsement and GAO workload.
Key Provisions
- Extends the Accelerating Access to Critical Therapies for ALS Act and its grant authorization through 2031.
- Requires grant-renewal review of enrollment, safety, and available efficacy data.
- Requires prompt reporting of new serious and unexpected safety information to grant institutions.
- Includes qualifying combined phase 2/3 trials within the phase 3 definition.
- Requires FDA to publish a five-year rare-neurodegenerative-disease action plan within 18 months.
- Requires FDA to publish an implementation report within five years.
- Removes the introduced direct-appropriation endorsement and four-year GAO report.
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
Extends federal ALS therapy-access and research-grant authorities through 2031, strengthens safety and evidence review for grant renewals, and requires a new five-year FDA rare-neurodegenerative-disease action plan.
Key Policy Areas
Healthcare, Medical Research, Drug Regulation
Primary Purpose
Extends federal ALS therapy-access and research-grant authorities through 2031, strengthens safety and evidence review for grant renewals, and requires a new five-year FDA rare-neurodegenerative-disease action plan.
Policy Domains
Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
Identified Gains
- People living with amyotrophic lateral sclerosis
- ALS clinical-trial participants
- ALS therapy researchers
- Rare neurodegenerative disease communities
- ALS expanded-access programs
- Congressional health committees
Identified Costs
- Investigational ALS drug manufacturers
- Investigational ALS drug sponsors
- ALS research grant applicants
- Health and Human Services grant reviewers
- Food and Drug Administration planning staff
- Federal taxpayers
Sponsors
Legislative Progress
ReportedReceived in the Senate. Read twice. Placed on Senate Legislative …
Received; read twice and placed on the calendar
Motion to reconsider laid on the table Agreed to without …
On motion to suspend the rules and pass the bill, …
Passed/agreed to in House: On motion to suspend the rules …
Considered as unfinished business.
Considered as unfinished business. (consideration: CR H5159)
At the conclusion of debate, the chair put the question …
DEBATE - The House proceeded with forty minutes of debate …
Considered under suspension of the rules. (consideration: CR H4652-4654; text: …
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Congressional appropriations committees, Congressional health committees, FDA Commissioner
Congressional health committees, Food and Drug Administration planning staff, Health and Human Services grant reviewers face effects in multiple directions
Positive-direction: Government Accountability Office analysts
Negative-direction: FDA Commissioner, FDA rare disease staff, GAO analysts, HHS grant reviewers, Health and Human Services grant staff
ALS expanded-access programs, ALS research grant applicants, ALS research grant recipients
ALS therapy researchers, Investigational ALS drug manufacturers, Rare-disease therapy developers face effects in multiple directions
Positive-direction: ALS expanded-access programs, ALS therapy developers, Patients with rare neurodegenerative diseases, People living with ALS
Negative-direction: ALS research grant applicants, ALS research grant recipients, Investigational ALS drug sponsors
ALS clinical-trial participants, People living with amyotrophic lateral sclerosis, Rare neurodegenerative disease communities
ALS clinical-trial participants, People living with amyotrophic lateral sclerosis, Rare neurodegenerative disease communities, Taxpayers face effects in multiple directions
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 manufacturers and sponsors
- "oversight_body"
- → Congressional health committees
- "regulatory_lead"
- → Commissioner of Food and Drugs
- "grant_recipients"
- → ALS research and expanded-access entities
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