Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
Sponsored By: Representative Quigley
Introduced
Summary
Extends the ALS Act authorization through 2031 and would tie grant renewals to clinical trial enrollment data while strengthening FDA planning and independent review to speed therapy development for ALS and related rare neurodegenerative diseases.
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- Families and patients: Would aim to keep funding and program support available through 2031 and push for faster, more transparent trial enrollment information that could clarify when later-stage studies are ready to enroll patients.
- Researchers and drug sponsors: Would require sponsors to share interim clinical trial data and let grant reviewers assess enrollment status when considering renewals, and it clarifies that combined phase 2/3 and planned phase 3 trials count as phase 3 for ALS purposes.
- FDA and oversight bodies: Would require the FDA Commissioner to publish a five-year action plan within one year that covers program and regulatory priorities across rare neurodegenerative diseases, and it would require a Government Accountability Office report within four years analyzing data called for in the ALS Act.
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Bill Overview
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Extend ALS research grants authorization
If enacted, the bill would extend the ALS Act's grant authorization by replacing "2026" with "2031." This would keep the program's grant authority in effect through 2031. The change would not itself appropriate new funds.
New FDA plan and GAO report
If enacted, the bill would require the FDA Commissioner to publish, within one year, an updated five-year action plan on the FDA website. The plan would list actions, resources needed, and approaches to coordinate with non-ALS rare neurodegenerative disease communities, and would describe the June 23, 2022 action plan and actions taken. The bill would also require the Comptroller General to deliver a GAO report to two congressional committees within four years, containing the analyses and data described in section 6 of the ALS Act.
New trial data and enrollment checks
If enacted, the bill would require the HHS Secretary to assess patient enrollment in clinical trials when reviewing renewal applications for grants tied to investigational drugs. The Secretary would request interim clinical trial data from drug sponsors to support that assessment. The bill would also treat phase 2/3 combined trials and planned phase 3 trials not yet enrolling as "phase 3" for program purposes.
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Sponsors & CoSponsors
Sponsor
Quigley
IL • D
Cosponsors
Calvert
CA • R
Sponsored 4/6/2026
Fitzpatrick
PA • R
Sponsored 4/9/2026
Schakowsky
IL • D
Sponsored 4/9/2026
McCaul
TX • R
Sponsored 4/9/2026
Garbarino
NY • R
Sponsored 4/16/2026
Auchincloss
MA • D
Sponsored 4/9/2026
DesJarlais
TN • R
Sponsored 4/9/2026
Craig
MN • D
Sponsored 4/9/2026
Valadao
CA • R
Sponsored 4/14/2026
Crow
CO • D
Sponsored 4/14/2026
Thompson (PA)
PA • R
Sponsored 4/14/2026
Moore (WI)
WI • D
Sponsored 4/14/2026
Hurd (CO)
CO • R
Sponsored 4/14/2026
Schneider
IL • D
Sponsored 4/14/2026
Joyce (OH)
OH • R
Sponsored 4/15/2026
Veasey
TX • D
Sponsored 4/15/2026
Salazar
FL • R
Sponsored 4/15/2026
Bonamici
OR • D
Sponsored 4/15/2026
Bilirakis
FL • R
Sponsored 4/16/2026
Sherman
CA • D
Sponsored 4/16/2026
Lynch
MA • D
Sponsored 4/16/2026
Bacon
NE • R
Sponsored 4/20/2026
Cohen
TN • D
Sponsored 4/20/2026
Sessions
TX • R
Sponsored 4/20/2026
Smith (WA)
WA • D
Sponsored 4/20/2026
Obernolte
CA • R
Sponsored 4/20/2026
Dean (PA)
PA • D
Sponsored 4/20/2026
Cole
OK • R
Sponsored 4/20/2026
Foushee
NC • D
Sponsored 4/20/2026
Sewell
AL • D
Sponsored 4/21/2026
Rutherford
FL • R
Sponsored 4/21/2026
Roll Call Votes
No roll call votes available for this bill.
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