H.R. 8205: Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
Sponsor
Mike Quigley
Democrat · IL-5
ALS patients shouldn't lose treatment access to a sunset date
Why it matters
The federal law that helps people with ALS get experimental drugs outside of clinical trials is set to expire in 2026. H.R. 8205 keeps it running through 2031, tightens how its grants get renewed, and gives the FDA 18 months to publish a public plan for ALS and other rare neurodegenerative diseases.
The 2021 ACT for ALS created a grant program that funds expanded access: getting investigational ALS drugs to patients who can't enroll in the late-stage trials testing them. Both the law and its grants are written to lapse in 2026.
H.R. 8205 moves that expiration to 2031, so patients, doctors and drug developers aren't planning around a program that could switch off.
The bill also changes what happens when a grant comes up for renewal. Federal reviewers would have to ask the drug's manufacturer or sponsor for enrollment numbers, safety data and any available evidence the drug works, and weigh all three before renewing.
Safety reporting gets a second channel. Grant recipients would have to promptly tell the grant-making institution about new, serious and unexpected side effects in the related late-stage trial, on top of what they already report to the FDA.
The definition of a qualifying late-stage trial widens slightly. A combined phase 2/3 study counts if it starts enrolling within a window the HHS Secretary sets in the grant terms.
Finally, the FDA would have 18 months to post a five-year action plan for rare neurodegenerative diseases, then publish a report within five years of enactment showing what it actually did. That gives patient groups a document they can hold the agency to.
Bill Progress
Latest Action · Sep 28, 2026
Passed Senate without amendment by Voice Vote. (consideration: CR S5120)
H.R. 8205 Bill Summary
What H.R. 8205 actually does.
Expanded access to ALS drugs continues through 2031
The ACT for ALS, including its authorization, is extended by five years, from 2026 to 2031.
Grants for patients outside trials keep running
The grant authority that funds expanded access to investigational ALS drugs is separately extended through 2031.
Renewals depend on enrollment, safety and results
Before renewing a grant for a specific drug, the HHS Secretary must request and assess enrollment, safety and any available efficacy data from the manufacturer or sponsor.
Serious surprises get reported to the funder
Grant recipients must promptly report new, serious and unexpected adverse events from the related phase 3 trial to the grant-making institution, in addition to existing FDA safety reporting.
Combined phase 2/3 trials can qualify
A phase 2/3 combined trial counts as phase 3 for the program if it begins enrollment within a timeframe the Secretary sets in the grant terms.
FDA owes a public five-year plan
The FDA Commissioner must post a rare neurodegenerative disease action plan within 18 months of enactment, and a report on actions taken under it within five years.
Who benefits from H.R. 8205?
People with ALS who can't get into a trial
Trials often exclude patients who are too far along or don't meet other criteria. Expanded access grants are a path to investigational drugs for them, and this bill keeps that path open through 2031.
Families planning around an ALS diagnosis
A five-year extension means treatment options reached through the program aren't tied to a 2026 cutoff.
ALS clinical researchers and trial sites
They get five more years of grant authority and written renewal criteria they can plan against.
Companies running combined phase 2/3 trials
Seamless phase 2/3 designs are common in rare disease research. The bill lets them qualify for the program if enrollment starts within the Secretary's window.
People with other rare neurodegenerative diseases
The FDA action plan covers the wider category of rare neurodegenerative diseases, not ALS alone.
Who is affected by H.R. 8205?
The FDA
Must publish a five-year action plan within 18 months and a public report on its follow-through within five years of enactment.
HHS grant reviewers
Must request and assess enrollment, safety and efficacy data before renewing a grant for any investigational drug.
Grant recipients
Take on an added duty to promptly report serious, unexpected safety findings to the grant-making institution, beyond FDA requirements.
Drug manufacturers and trial sponsors
Will be asked to hand over enrollment, safety and efficacy data when grants tied to their drugs come up for renewal.
What Congress Is Saying
H.R. 8205 has come up 21 times in the Congressional Record so far.
H.R. 8205 also appeared in 1 more House floor reference and 18 routine cosponsor filings.
HR8205 Legislative Journey
Passed
Sep 28, 2026
Passed Senate without amendment by Voice Vote. (consideration: CR S5120)
+1 more action this day
Sent to Senate
Jul 23, 2026
Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 466.
House: Vote Held
Jul 22, 2026
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.
House: Floor Debate
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.
House: Committee Action
Jul 9, 2026
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-733.
House: Vote: 46-0
May 21, 2026
Ordered to be Reported (Amended) by the Yeas and Nays: 46 - 0.
House: Vote Held
May 13, 2026
Forwarded by Subcommittee to Full Committee by Voice Vote.
House: Committee Action
Apr 6, 2026
Referred to the Subcommittee on Health.
About the Sponsor
Mike Quigley
Democrat, Illinois's 5th congressional district · 17 years in Congress
Committees: Appropriations, House Permanent Select Committee on Intelligence
View full profile →
Cosponsors (103)
This bill has 103 cosponsors: 64 Democrats, 39 Republicans, reflecting bipartisan support. Cosponsors represent 37 states: Alabama, Arkansas, Arizona, and 34 more.
Ken Calvert
Republican · CA
Brian Fitzpatrick
Republican · PA
Janice Schakowsky
Democrat · IL
Michael McCaul
Republican · TX
Jake Auchincloss
Democrat · MA
Scott DesJarlais
Republican · TN
Angie Craig
Democrat · MN
David Valadao
Republican · CA
Jason Crow
Democrat · CO
Glenn Thompson
Republican · PA
Gwen Moore
Democrat · WI
Jeff Hurd
Republican · CO
Cosponsor Coverage Map
Committee Sponsors
Energy and Commerce Committee
14 of 54 committee members cosponsored
13 Democrats across this committee haven't cosponsored yet. Mobilize their constituents
What laws does H.R. 8205 change?
4 changes
Sections Amended
Section 7 of Accelerating Access to Critical Therapies for ALS Act (Public Law 117-79)
striking ``2026'' and inserting ``2031''
Section 2(f) of Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note)
striking ``2026'' and inserting ``2031''
Section 2(b) of Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note)
adding at the end the following: ``(4) Renewal of grants for research on therapies for als review
Section 2(e) of Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note)
adding at the end the following: ``(4) The term `phase 3', with respect to a clinical trial, includes a phase 2/3 combined trial that begins enrollment within a timeframe, determined by the Secretary through the terms and conditions of the grant awarded under this section
H.R. 8205 Quick Facts
- Committee
- Energy and Commerce
- Chamber
- House
- Policy
- Health
- Introduced
- Apr 6, 2026
Passed Senate without amendment by Voice Vote. (consideration: CR S5120)
Sep 28, 2026
Official Sources
Official text, actions and cosponsors for the ACT for ALS Reauthorization Act of 2026.
The 2021 law whose 2026 sunsets H.R. 8205 moves to 2031.
How the FDA carries out the law: the public-private partnership, the action plan and the grant program.
The current five-year plan written under Section 4 of the 2021 law, which H.R. 8205 requires the FDA to renew and report on.
Explains how patients reach investigational drugs outside clinical trials, the pathway the ACT for ALS grants fund.
The FDA grant program launched under the ACT for ALS for research on ALS and related diseases.
The existing FDA safety reporting rule that the bill layers a second reporting duty on top of.
H.R. 8205 Common Questions
What does H.R. 8205 do?
It extends the 2021 ACT for ALS through 2031, adds new review standards for renewing its grants, requires faster reporting of serious safety problems, and makes the FDA publish a five-year plan for rare neurodegenerative diseases.
When does the ACT for ALS expire?
Under current law, 2026. H.R. 8205 moves that date to 2031 for both the law and its research grants.
Can I get an experimental ALS drug if I don't qualify for a trial?
Possibly. The ACT for ALS funds expanded access, which provides investigational drugs to some patients who can't enroll in the trials testing them. Availability depends on the drug and its sponsor. Ask your neurologist or an ALS clinic.
Does H.R. 8205 add new ALS funding?
No. It extends the existing authority through 2031 without setting a new dollar amount. How much the program gets is decided each year in appropriations.
What changes when an ALS grant is renewed?
Reviewers would have to request enrollment, safety and any available efficacy data from the drug's manufacturer or sponsor, and assess it before renewing.
Do phase 2/3 ALS trials count under the program?
Yes, if the combined trial starts enrolling within a timeframe the HHS Secretary sets in the grant terms.
What is the FDA rare neurodegenerative disease action plan?
A public plan the FDA would have to post within 18 months, laying out what it intends to do over the next five years. A follow-up report on what it actually did is due within five years of enactment.
Has H.R. 8205 passed?
It passed the House by voice vote on July 22, 2026, and was placed on the Senate calendar the next day. It still needs a Senate vote and the President's signature.
Based on H.R. 8205 bill text
H.R. 8205 Bill Text
“To amend the Accelerating Access to Critical Therapies for ALS Act to reauthorize the provisions of such Act through fiscal year 2031, and for other purposes.”
Source: U.S. Government Publishing Office
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