H.R. 8205: Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
This bill would extend and update a federal law aimed at helping ALS-related therapies move through research and development more effectively.
What it changes
- Extends the ALS therapy program through fiscal year 2031. Current authority that was set to expire in 2026 would be pushed out to 2031.
- Continues grant funding for ALS research. The bill extends the period during which the government can award grants for research on ALS therapies.
- Adds more review requirements for grant renewals. When a grant is renewed for an investigational ALS drug, the Secretary of Health and Human Services would have to request and evaluate data on:
- how many people enrolled in the trial,
- safety results, and
- any available evidence about whether the drug is effective.
- Requires quicker reporting of serious safety problems. Entities receiving grants would have to promptly report any new, serious, and unexpected adverse events or safety information from phase 3 trials to the grant-making institution, in addition to existing FDA safety-reporting rules.
- Clarifies what counts as a phase 3 trial. The bill says that a “phase 3” trial can include a combined phase 2/3 trial, as long as enrollment starts within a time frame set by the Secretary in the grant terms.
- Updates FDA planning requirements. It renames the existing ALS-focused FDA plan as an “FDA rare neurodegenerative disease action plan,” and requires FDA to:
- publish an action plan within 18 months of enactment describing steps it plans to take over the next 5 years, and
- publish a follow-up report within 5 years describing what it did and how well the plan was carried out.
Practical effect
In plain terms, the bill keeps a federal ALS research and access program going for several more years, adds some extra oversight for grant-funded drug trials, broadens how certain clinical trials can qualify, and requires FDA to publish a more detailed long-term plan for rare neurodegenerative diseases.
Relevant Companies
- BIIB — Biogen may be directly affected because it has been involved in ALS-related therapy development and could be influenced by federal research and regulatory pathways for neurodegenerative disease treatments.
- AMRN — Amarin is not an ALS company, but the bill’s broader FDA planning and trial-related provisions could indirectly affect clinical development practices for companies working on rare-disease therapies. Direct impact is likely limited.
This is an AI-generated summary of the bill text. There may be mistakes.
Sponsors
104 bill sponsors
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TrackMike Quigley
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TrackAlma S. Adams
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TrackRobert B. Aderholt
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TrackMark Alford
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TrackMark E. Amodei
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TrackJake Auchincloss
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TrackDon Bacon
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TrackJoyce Beatty
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TrackStephanie I. Bice
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TrackGus M. Bilirakis
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TrackSanford D. Bishop, Jr.
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TrackSuzanne Bonamici
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TrackMike Bost
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TrackNikki Budzinski
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TrackJanelle Bynum
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TrackKen Calvert
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TrackJohn R. Carter
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TrackTroy A. Carter
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TrackSean Casten
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TrackEmanuel Cleaver
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TrackSteve Cohen
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TrackTom Cole
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TrackHerbert Conaway
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TrackJ. Luis Correa
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TrackAngie Craig
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TrackJason Crow
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TrackDonald G. Davis
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TrackDanny K. Davis
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TrackMadeleine Dean
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TrackSuzan K. DelBene
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TrackScott DesJarlais
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TrackMario Diaz-Balart
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TrackDebbie Dingell
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TrackChuck Edwards
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TrackBrian K. Fitzpatrick
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TrackValerie P. Foushee
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TrackAndrew R. Garbarino
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TrackJosh Gottheimer
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TrackMichael Guest
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TrackJahana Hayes
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TrackJames A. Himes
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TrackJeff Hurd
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TrackJonathan L. Jackson
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TrackDavid P. Joyce
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TrackMarcy Kaptur
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TrackRobin L. Kelly
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TrackTimothy M. Kennedy
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TrackYoung Kim
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TrackRaja Krishnamoorthi
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TrackDarin LaHood
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TrackNick LaLota
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TrackGreg Landsman
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TrackJohn B. Larson
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TrackGeorge Latimer
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TrackJulia Letlow
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TrackStephen F. Lynch
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TrackSeth Magaziner
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TrackTracey Mann
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TrackDoris O. Matsui
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TrackSarah McBride
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TrackMichael T. McCaul
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TrackCarol D. Miller
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TrackTim Moore
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TrackGwen Moore
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TrackEleanor Holmes Norton
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TrackJay Obernolte
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TrackScott H. Peters
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TrackChellie Pingree
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TrackJosh Riley
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TrackDeborah K. Ross
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TrackDavid Rouzer
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TrackJohn H. Rutherford
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TrackMaria Elvira Salazar
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TrackMary Gay Scanlon
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TrackJanice D. Schakowsky
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TrackBradley Scott Schneider
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TrackKim Schrier
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TrackPete Sessions
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TrackTerri A. Sewell
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TrackBrad Sherman
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TrackAdam Smith
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TrackEric Sorensen
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TrackMelanie A. Stansbury
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TrackGreg Stanton
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TrackThomas R. Suozzi
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TrackMike Thompson
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TrackGlenn Thompson
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TrackRashida Tlaib
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TrackPaul Tonko
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TrackRitchie Torres
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TrackLauren Underwood
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TrackDavid G. Valadao
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TrackJefferson Van Drew
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TrackMarc A. Veasey
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TrackEugene Vindman
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TrackTim Walberg
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TrackBonnie Watson Coleman
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TrackRandy K. Weber, Sr.
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TrackGeorge Whitesides
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TrackJoe Wilson
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TrackRobert J. Wittman
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TrackSteve Womack
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Tracknan
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Tracknan
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Actions
20 actions
| Date | Action |
|---|---|
| Sep. 28, 2026 | Passed/agreed to in Senate: Passed Senate without amendment by Voice Vote. (consideration: CR S5120) |
| Sep. 28, 2026 | Passed Senate without amendment by Voice Vote. (consideration: CR S5120) |
| Jul. 23, 2026 | Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 466. |
| Jul. 22, 2026 | Considered as unfinished business. (consideration: CR H5159) |
| Jul. 22, 2026 | Motion to reconsider laid on the table Agreed to without objection. |
| Jul. 22, 2026 | On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. |
| Jul. 22, 2026 | Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. |
| Jul. 20, 2026 | At the conclusion of debate, the chair put the question on the motion to suspend the rules. Mr. Guthrie objected to the vote on the grounds that a quorum was not present. Further proceedings on the motion were postponed. The point of no quorum was considered as withdrawn. |
| Jul. 20, 2026 | Considered under suspension of the rules. (consideration: CR H4652-4654; text: CR H4653) |
| Jul. 20, 2026 | DEBATE - The House proceeded with forty minutes of debate on H.R. 8205. |
| Jul. 20, 2026 | Mr. Guthrie moved to suspend the rules and pass the bill, as amended. |
| Jul. 09, 2026 | Placed on the Union Calendar, Calendar No. 637. |
| Jul. 09, 2026 | Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-733. |
| May. 21, 2026 | Committee Consideration and Mark-up Session Held |
| May. 21, 2026 | Ordered to be Reported (Amended) by the Yeas and Nays: 46 - 0. |
| May. 13, 2026 | Forwarded by Subcommittee to Full Committee by Voice Vote. |
| May. 13, 2026 | Subcommittee Consideration and Mark-up Session Held |
| Apr. 06, 2026 | Introduced in House |
| Apr. 06, 2026 | Referred to the House Committee on Energy and Commerce. |
| Apr. 06, 2026 | Referred to the Subcommittee on Health. |
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