S. 4472: Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
Sponsor
Lisa Murkowski
Republican · AK
Keep the door to experimental ALS drugs open
Why it matters
ALS usually kills within three to five years of the first symptoms, according to NIH — faster than most drugs can finish trials. S. 4472 keeps the federal program that funds early access to investigational ALS treatments running five more years, through 2031, and requires the access to produce research data in return.
In 2021, Congress passed the Accelerating Access to Critical Therapies for ALS Act, which funds grants that let people with ALS who can't join clinical trials receive investigational drugs anyway. Its authority runs out after fiscal year 2026.
S. 4472 extends the program for five more fiscal years, 2027 through 2031, so patients outside clinical trials keep a funded path to experimental ALS drugs. ALS research grants under the same law are extended on the same timeline.
The extension comes with conditions. Anyone applying for an expanded-access grant would have to explain how the data it generates will feed ALS research or drug development. Grant recipients would also have to promptly report safety data from any ongoing trial of the same drug.
Renewals get a closer look. Before continuing a grant, HHS would have to request and review the drug sponsor's enrollment, safety, and any available efficacy data. Funded projects would also have to start enrolling patients within a deadline HHS sets.
More drugs could qualify earlier: a combined phase 2/3 trial counts, and so does a planned phase 3 trial that hasn't started enrolling yet. That matters for patients because the program is tied to drugs already in late-stage testing.
The FDA would have to update its ALS and rare neurodegenerative disease action plan within one year, then every five years, including what it did under the last plan and what's in its way. HHS would owe Congress a report on whether the program is working within four years.
The rest is housekeeping, including fixing a misspelling of "amyotrophic" in the original law.
Bill Progress
Latest Action · Aug 10, 2026
Passed the Senate, received in House
S. 4472 Bill Summary
What S. 4472 actually does.
Early access to ALS drugs lasts through 2031
Extends federal expanded-access grants and ALS research grants for fiscal years 2027 through 2031, replacing the 2022-2026 window in the original law.
Access has to produce research
Grant applicants must describe how data from their expanded-access program will support research or development for preventing, diagnosing, treating, or curing ALS.
Safety problems get reported quickly
Grant recipients must promptly report available safety data from any ongoing clinical trial of the investigational drug, under the grant's terms.
Renewals depend on the data
Before renewing a grant, HHS must request and assess the drug sponsor's enrollment, safety, and any available efficacy data.
Drugs can qualify at an earlier stage
A combined phase 2/3 trial counts as a phase 3 trial, and so does a planned phase 3 trial that isn't enrolling yet. Funded projects must begin enrolling patients within a timeframe HHS sets.
FDA and HHS must report on progress
FDA must update its ALS and rare neurodegenerative disease action plan within 1 year and every 5 years, including barriers and resources needed. HHS must report to Congress on the program's effectiveness within 4 years.
Who benefits from S. 4472?
People with ALS who can't get into a clinical trial
Patients who are too sick, too far from a trial site, or outside a study's eligibility rules keep a federally funded route to investigational drugs through 2031.
Patients waiting on drugs still early in late-stage testing
Because planned phase 3 and combined phase 2/3 trials now count, a drug can enter the program before its main trial starts enrolling.
Families and caregivers
They get more predictability: a program with a five-year runway instead of one whose authority lapses after fiscal year 2026.
ALS researchers and future patients
Data from expanded-access patients must now be put to research use, so treatment given outside trials can inform what gets approved next.
Who is affected by S. 4472?
Hospitals and clinics applying for grants
They must show upfront how their program's data will support ALS research, and commit to enrolling patients within an HHS deadline.
Drug companies with ALS therapies in development
When a grant tied to their drug is renewed, they must hand HHS enrollment, safety, and any available efficacy data for review.
Grant recipients
They must promptly pass along safety data from ongoing clinical trials of the same drug.
FDA and HHS
FDA takes on a recurring action-plan update every 5 years; HHS owes Congress an effectiveness review within 4 years.
S4472 Legislative Journey
House: Action Taken
Aug 10, 2026
Held at the desk.
Passed 4425-4426
Aug 4, 2026
Passed Senate with an amendment by Voice Vote. (consideration: CR S4425-4426; text: CR S4425-4426)
+1 more action this day
Committee Action
Jul 16, 2026
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Passed Committee
Jun 17, 2026
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Committee Action
Apr 30, 2026
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
About the Sponsor
Lisa Murkowski
Republican, AK · 24 years in Congress
Committees: Indian Affairs, Appropriations, Health, Education, Labor, and Pensions
View full profile →
Cosponsors (15)
This bill has 15 cosponsors: 8 Democrats, 7 Republicans, reflecting bipartisan support. Cosponsors represent 15 states: California, Delaware, Indiana, and 12 more.
Christopher Coons
Democrat · DE
Susan Collins
Republican · ME
Amy Klobuchar
Democrat · MN
Alex Padilla
Democrat · CA
Shelley Capito
Republican · WV
John Curtis
Republican · UT
Kirsten Gillibrand
Democrat · NY
Maggie Hassan
Democrat · NH
Jim Banks
Republican · IN
Edward Markey
Democrat · MA
Steve Daines
Republican · MT
Jeff Merkley
Democrat · OR
Committee Sponsors
Health, Education, Labor, and Pensions Committee
4 of 23 committee members cosponsored
10 Republicans across this committee haven't cosponsored yet. Mobilize their constituents
What laws does S. 4472 change?
2 changes
Sections Amended
Section 7 of Accelerating Access to Critical Therapies for ALS Act (Public Law 117-79)
striking ``2022 through 2026'' and inserting ``2027 through 2031''
Section 2(f) of Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note)
striking ``2026'' and inserting ``2031''
S. 4472 Quick Facts
- Committee
- Health, Education, Labor, and Pensions
- Chamber
- Senate
- Policy
- Health
- Introduced
- Apr 30, 2026
Passed the Senate, received in House
Aug 10, 2026
Official Sources
Official text, status, and cosponsors for the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026.
FDA hub for implementing the 2021 law this bill reauthorizes, including the action plan, grants, and public-private partnership.
The five-year action plan S. 4472 would require FDA to update within one year and every five years after.
How patients outside clinical trials can seek investigational drugs, the pathway the bill's grants fund for ALS.
FDA grants for ALS and other rare neurodegenerative disease research, authorized by the same 2021 law the bill extends.
Official text of the original Accelerating Access to Critical Therapies for ALS Act that S. 4472 amends.
The HHS public-private partnership for rare neurodegenerative diseases, which the bill corrects in its technical amendments.
S. 4472 Common Questions
What does S. 4472 do?
It keeps the federal program that funds early access to experimental ALS drugs running through 2031, and adds requirements for research data, safety reporting, and faster patient enrollment.
What happens to ALS expanded access if S. 4472 doesn't pass?
The program's authority covers fiscal years 2022 through 2026. Without an extension, there's no authorization for new funding after September 30, 2026, though Congress could still act later.
How can I get an experimental ALS drug if I don't qualify for a clinical trial?
Expanded access lets doctors request investigational drugs for patients outside trials. This program funds those efforts for drugs in late-stage testing. Ask your neurologist or an ALS clinic whether one is available for you.
Can a drug qualify before its phase 3 trial starts?
Yes. The bill counts a planned phase 3 trial that isn't enrolling yet, plus combined phase 2/3 trials. That lets drugs enter the program earlier in development.
Does S. 4472 require data from patients who get expanded access?
Grant applicants would have to explain how data from the program will support ALS research or drug development. Renewals also depend on HHS reviewing the drug's enrollment, safety, and efficacy data.
Does S. 4472 cover diseases other than ALS?
The grants are ALS-only. But FDA's recurring action plan also covers other rare neurodegenerative diseases, and must list barriers to developing treatments and the resources needed to address them.
Has S. 4472 passed?
It passed the Senate by voice vote on August 4, 2026, and is held at the desk in the House, so the House can vote on it without committee action first. It has bipartisan cosponsors.
Who will check whether the ALS program is working?
HHS must send Congress a report on the program's effectiveness, with recommendations, within 4 years of enactment. FDA must update its ALS action plan within 1 year and every 5 years after.
Based on S. 4472 bill text
S. 4472 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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