Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
Sponsored By: Representative Quigley, Mike [D-IL-5]
Introduced
Summary
Extends and strengthens the federal program to speed development of ALS therapies through 2031. This bill would reauthorize the Accelerating Access to Critical Therapies for ALS Act and add requirements for clinical-trial data sharing, clearer trial phase definitions, and agency planning and oversight.
Show full summary
- Families and patients: Aims to improve therapy development by requiring manufacturers to share interim clinical trial data and by clarifying that combined phase 2/3 trials and planned phase 3 trials count as phase 3, which affects how late-stage studies are judged.
- Researchers and drug makers: Would tie grant renewal reviews for investigational drugs to enrollment data and require sharing of interim trial results to support those renewal decisions.
- FDA and oversight: Directs the Food and Drug Administration to publish a five-year action plan with resource needs within 1 year and requires the Comptroller General to deliver a Government Accountability Office report to Congress within 4 years.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
Extend ALS therapies program through 2031
This bill would extend the Accelerating Access to Critical Therapies for ALS Act through fiscal year 2031. It would also clarify that a combined phase 2/3 trial and a planned phase 3 trial not yet enrolling count as "phase 3" for the program. These changes would keep the grant program authority in place and adjust how some trials are classified, but would not itself appropriate money or change who is eligible.
New data rules for ALS drug grants
This bill would require the Secretary to assess clinical trial status using patient enrollment data when reviewing renewals of grants for investigational ALS drugs. It would also require the Secretary to request interim clinical-trial data from the drug manufacturer to enable that assessment. If enacted, grant applicants and drug makers would need to provide this interim data as part of renewal reviews.
Sponsors & CoSponsors
Sponsor
Quigley, Mike [D-IL-5]
IL • D
Cosponsors
Rep. Calvert, Ken [R-CA-41]
CA • R
Sponsored 4/6/2026
Rep. Fitzpatrick, Brian K. [R-PA-1]
PA • R
Sponsored 4/9/2026
Schakowsky
IL • D
Sponsored 4/9/2026
Rep. McCaul, Michael T. [R-TX-10]
TX • R
Sponsored 4/9/2026
Auchincloss
MA • D
Sponsored 4/9/2026
DesJarlais
TN • R
Sponsored 4/9/2026
Craig
MN • D
Sponsored 4/9/2026
Rep. Valadao, David G. [R-CA-22]
CA • R
Sponsored 4/14/2026
Crow
CO • D
Sponsored 4/14/2026
Rep. Thompson, Glenn [R-PA-15]
PA • R
Sponsored 4/14/2026
Rep. Moore, Gwen [D-WI-4]
WI • D
Sponsored 4/14/2026
Rep. Hurd, Jeff [R-CO-3]
CO • R
Sponsored 4/14/2026
Rep. Schneider, Bradley Scott [D-IL-10]
IL • D
Sponsored 4/14/2026
Rep. Joyce, David P. [R-OH-14]
OH • R
Sponsored 4/15/2026
Rep. Veasey, Marc A. [D-TX-33]
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
Rep. Sherman, Brad [D-CA-32]
CA • D
Sponsored 4/16/2026
Rep. Garbarino, Andrew R. [R-NY-2]
NY • R
Sponsored 4/16/2026
Rep. Lynch, Stephen F. [D-MA-8]
MA • D
Sponsored 4/16/2026
Rep. Bacon, Don [R-NE-2]
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
Rep. Dean, Madeleine [D-PA-4]
PA • D
Sponsored 4/20/2026
Cole
OK • R
Sponsored 4/20/2026
Rep. Foushee, Valerie P. [D-NC-4]
NC • D
Sponsored 4/20/2026
Rutherford
FL • R
Sponsored 4/21/2026
Sewell
AL • D
Sponsored 4/21/2026
Rep. Wilson, Joe [R-SC-2]
SC • R
Sponsored 4/22/2026
Davis (IL)
IL • D
Sponsored 4/22/2026
Aderholt
AL • R
Sponsored 4/23/2026
Rep. Torres, Ritchie [D-NY-15]
NY • D
Sponsored 4/23/2026
Rep. Mann, Tracey [R-KS-1]
KS • R
Sponsored 4/30/2026
Del. Norton, Eleanor Holmes [D-DC-At Large]
DC • D
Sponsored 4/30/2026
Van Drew
NJ • R
Sponsored 5/4/2026
Rep. Krishnamoorthi, Raja [D-IL-8]
IL • D
Sponsored 5/4/2026
Rep. Alford, Mark [R-MO-4]
MO • R
Sponsored 5/7/2026
Rep. Underwood, Lauren [D-IL-14]
IL • D
Sponsored 5/7/2026
LaLota
NY • R
Sponsored 5/7/2026
Schrier
WA • D
Sponsored 5/7/2026
Rep. Kim, Young [R-CA-40]
CA • R
Sponsored 5/11/2026
Rep. Matsui, Doris O. [D-CA-7]
CA • D
Sponsored 5/11/2026
Edwards
NC • R
Sponsored 5/11/2026
Rep. Dingell, Debbie [D-MI-6]
MI • D
Sponsored 5/11/2026
Rep. Walberg, Tim [R-MI-5]
MI • R
Sponsored 5/12/2026
Rep. Tlaib, Rashida [D-MI-12]
MI • D
Sponsored 5/12/2026
Rep. Weber, Randy K. Sr. [R-TX-14]
TX • R
Sponsored 5/12/2026
Thompson (CA)
CA • D
Sponsored 5/12/2026
Bost
IL • R
Sponsored 5/12/2026
Rep. Tonko, Paul [D-NY-20]
NY • D
Sponsored 5/12/2026
Rep. Bice, Stephanie I. [R-OK-5]
OK • R
Sponsored 5/13/2026
DelBene
WA • D
Sponsored 5/13/2026
Rep. Diaz-Balart, Mario [R-FL-26]
FL • R
Sponsored 5/14/2026
Rep. Correa, J. Luis [D-CA-46]
CA • D
Sponsored 5/14/2026
LaHood
IL • R
Sponsored 5/14/2026
Kennedy (NY)
NY • D
Sponsored 5/14/2026
Roll Call Votes
No roll call votes available for this bill.
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