WHAT THE LAW DOINCongress, in plain words

H.R. 8205 · 119th Congress

Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

Sent to PresidentHealth
IntroducedApr 6, 2026
Passed HouseJul 22, 2026
Passed SenateSep 28, 2026
To PresidentOct 26, 2026
Became lawNot yet

How this bill changes the law

Sourced

H.R. 8205 would change 3 sections of existing law. Read from the bill text in its final form, as sent to the President.

Public Law 117-79 An earlier law, changed directly

21 U.S.C. 360ee

21 U.S.C. 360aa

What the words would change: every change, in place (9)

Today's wording of each part of the law, with what would be struck out and added. Each change also gives the bill's own instruction, word for word.

  1. Public Law 117-79changedby H.R. 8205 Sec. 2(a)

    The bill says: Section 7 of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117–79) is amended by striking "2026" and inserting "2031".

    Bill text

  2. 21 U.S.C. 360ee(f)changedby H.R. 8205 Sec. 2(b)

    The bill says: Section 2(f) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by striking "2026" and inserting "2031".

    Bill text · Current law (21 U.S.C. 360ee)

  3. 21 U.S.C. 360ee(b)added (4)by H.R. 8205 Sec. 3(a)

    (4) Renewal of grants for research on therapies for ALS review.— In reviewing applications for renewals of a grant awarded under this section with respect to an investigational drug, the Secretary shall request from the manufacturer or sponsor, and assess, the enrollment, safety, and any available efficacy data relating to the investigational drug in the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis.

    The bill says: Section 2(b) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by adding at the end the following:

    Bill text · Current law (21 U.S.C. 360ee)

  4. 21 U.S.C. 360ee(c)(2)(B)changedby H.R. 8205 Sec. 3(b)

    The bill says: in paragraph (2)(B), by striking "and" at the end;

    Bill text · Current law (21 U.S.C. 360ee)

  5. 21 U.S.C. 360ee(c)(3)changedby H.R. 8205 Sec. 3(b)

    The bill says: in paragraph (3), by striking the period at the end and inserting "; and"; and

    Bill text · Current law (21 U.S.C. 360ee)

  6. 21 U.S.C. 360ee(c)added (4)by H.R. 8205 Sec. 3(b)

    (4) the entity seeking such grant will promptly report any new and serious adverse events and safety information that is considered to be unexpected with respect to the phase 3 trial to the grant-making institution, in addition to complying with the safety reporting requirements under section 312.32 of title 21, Code of Federal Regulations (or any successor regulations).

    The bill says: by adding at the end the following:

    Bill text · Current law (21 U.S.C. 360ee)

  7. 21 U.S.C. 360ee(e)added (4)by H.R. 8205 Sec. 3(c)

    (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.

    The bill says: Section 2(e) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by adding at the end the following:

    Bill text · Current law (21 U.S.C. 360ee)

  8. 21 U.S.C. 360aachangedby H.R. 8205 Sec. 4(1)

    The bill says: in the section heading, by striking "ALS and other rare neurodegenerative disease action plan" and inserting "FDA rare neurodegenerative disease action plan"; and

    Bill text · Current law (21 U.S.C. 360aa)

  9. 21 U.S.C. 360aaadded (c)by H.R. 8205 Sec. 4(2)

    (c) FDA rare neurodegenerative disease action plan.—(1) In general.— Not later than 18 months after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, the Commissioner of Food and Drugs shall publish on the website of the Food and Drug Administration an action plan that includes a description of the actions that the Food and Drug Administration intends to take during the 5-year period following publication of the action plan with respect to the program enhancements, policy development, regulatory science initiatives, and other appropriate initiatives described in subsection (a).(2) Report.— Not later than 5 years after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, the Commissioner of Food and Drugs shall publish on the website of the Food and Drug Administration a report that describes the actions taken by the Food and Drug Administration under the action plan published under paragraph (1) and the extent to which such action plan meets the requirements specified in paragraph (1).

    The bill says: by adding at the end the following:

    Bill text · Current law (21 U.S.C. 360aa)

From the bill's official text on GovInfo and the U.S. Code, latest edition, which may not yet show changes made since.

What it does

Sourced

Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

This bill reauthorizes through FY2031 and revises programs that support research and development of drugs and other therapies to address amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease) and other neurodegenerative diseases.

The bill reauthorizes

• grants from the National Institutes of Health (NIH) for scientific research on investigational drugs to prevent or treat ALS for individuals not otherwise eligible for clinical trials,

• grants from the Food and Drug Administration (FDA) for research and development of therapies to prevent and treat ALS and other neurodegenerative diseases, and

• a Public-Private Partnership including the FDA and NIH that supports development and regulatory review of treatments for neurodegenerative diseases.

Also, the NIH, in considering renewal of its grants, must assess available information on the safety and efficacy of the investigational drugs. It must also require grantees to promptly report serious and unexpected adverse events associated with their investigational drugs.

Additionally, the FDA must publish a plan describing actions it will take over a five-year period to foster development of safe and effective drugs, and facilitate access to investigational drugs, that treat ALS and other rare neurodegenerative diseases. The FDA must also publish a report describing the actions it has taken under the plan.

Official summary by the Congressional Research Service (Reported to House, Jul 9, 2026).

Our plain-language breakdown, with what it means for you and the case for and against, is written once a bill starts to move.

What has happened

Sourced
  1. 2026-10-26Presented to President.House floor actions
  2. 2026-10-26Presented to President.Library of Congress
  3. 2026-10-14Message on Senate action sent to the House.Senate
  4. 2026-09-28Passed Senate without amendment by Voice Vote. (consideration: CR S5120)Senate
  5. 2026-09-28Passed/agreed to in Senate: Passed Senate without amendment by Voice Vote. (consideration: CR S5120)Library of Congress
  6. 2026-07-23Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 466.Senate
  7. 2026-07-22Motion to reconsider laid on the table Agreed to without objection.House floor actions
  8. 2026-07-22On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.House floor actions
  9. 2026-07-22Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.Library of Congress
  10. 2026-07-22Considered as unfinished business. (consideration: CR H5159)House floor actions
  11. 2026-07-20At 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 floor actions
  12. 2026-07-20DEBATE - The House proceeded with forty minutes of debate on H.R. 8205.House floor actions
  13. 2026-07-20Considered under suspension of the rules. (consideration: CR H4652-4654; text: CR H4653)House floor actions
  14. 2026-07-20Mr. Guthrie moved to suspend the rules and pass the bill, as amended.House floor actions
  15. 2026-07-09Placed on the Union Calendar, Calendar No. 637.House floor actions
  16. 2026-07-09Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-733.House floor actions
  17. 2026-07-09Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-733.Library of Congress
  18. 2026-05-21Ordered to be Reported (Amended) by the Yeas and Nays: 46 - 0.House committee actions
  19. 2026-05-21Committee Consideration and Mark-up Session HeldHouse committee actions
  20. 2026-05-13Forwarded by Subcommittee to Full Committee by Voice Vote.House committee actions
  21. 2026-05-13Subcommittee Consideration and Mark-up Session HeldHouse committee actions
  22. 2026-04-06Referred to the Subcommittee on Health.House committee actions
  23. 2026-04-06Referred to the House Committee on Energy and Commerce.House floor actions
  24. 2026-04-06Introduced in HouseLibrary of Congress
  25. 2026-04-06Introduced in HouseLibrary of Congress

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Cosponsors

  • Alma S. Adams D-NC-12
  • Robert B. Aderholt R-AL-4
  • Mark Alford R-MO-4
  • Mark E. Amodei R-NV-2
  • Jake Auchincloss D-MA-4
  • Don Bacon R-NE-2
  • Joyce Beatty D-OH-3
  • Stephanie I. Bice R-OK-5
  • Gus M. Bilirakis R-FL-12
  • Sanford D. Bishop, Jr. D-GA-2
  • Suzanne Bonamici D-OR-1
  • Mike Bost R-IL-12
  • Nikki Budzinski D-IL-13
  • Janelle S. Bynum D-OR-5
  • Ken Calvert R-CA-41
  • John R. Carter R-TX-31
  • Troy A. Carter D-LA-2
  • Sean Casten D-IL-6
  • Emanuel Cleaver D-MO-5
  • Steve Cohen D-TN-9
  • Tom Cole R-OK-4
  • Herbert C. Conaway, Jr. D-NJ-3
  • J. Luis Correa D-CA-46
  • Angie Craig D-MN-2
  • Jason Crow D-CO-6
  • Donald G. Davis D-NC-1
  • Danny K. Davis D-IL-7
  • Madeleine Dean D-PA-4
  • Suzan K. DelBene D-WA-1
  • Scott DesJarlais R-TN-4
  • Mario Diaz-Balart R-FL-26
  • Debbie Dingell D-MI-6
  • Chuck Edwards R-NC-11
  • Brian K. Fitzpatrick R-PA-1
  • Valerie P. Foushee D-NC-4
  • Andrew R. Garbarino R-NY-2
  • Josh Gottheimer D-NJ-5
  • Adelita S. Grijalva D-AZ-7
  • Michael Guest R-MS-3
  • Jahana Hayes D-CT-5
  • James A. Himes D-CT-4
  • Jeff Hurd R-CO-3
  • Jonathan L. Jackson D-IL-1
  • David P. Joyce R-OH-14
  • Marcy Kaptur D-OH-9
  • Robin L. Kelly D-IL-2
  • Timothy M. Kennedy D-NY-26
  • Young Kim R-CA-40
  • Raja Krishnamoorthi D-IL-8
  • Darin LaHood R-IL-16
  • Nick LaLota R-NY-1
  • Greg Landsman D-OH-1
  • John B. Larson D-CT-1
  • George Latimer D-NY-16
  • Julia Letlow R-LA-5
  • Stephen F. Lynch D-MA-8
  • Seth Magaziner D-RI-2
  • Tracey Mann R-KS-1
  • Doris O. Matsui D-CA-7
  • Sarah McBride D-DE-At Large
  • Michael T. McCaul R-TX-10
  • Analilia Mejia D-NJ-11
  • Carol D. Miller R-WV-1
  • Gwen Moore D-WI-4
  • Tim Moore R-NC-14
  • Eleanor Holmes Norton D-DC-At Large
  • Jay Obernolte R-CA-23
  • Scott H. Peters D-CA-50
  • Chellie Pingree D-ME-1
  • Josh Riley D-NY-19
  • Deborah K. Ross D-NC-2
  • David Rouzer R-NC-7
  • John H. Rutherford R-FL-5
  • Maria Elvira Salazar R-FL-27
  • Mary Gay Scanlon D-PA-5
  • Janice D. Schakowsky D-IL-9
  • Bradley Scott Schneider D-IL-10
  • Kim Schrier D-WA-8
  • Pete Sessions R-TX-17
  • Terri A. Sewell D-AL-7
  • Brad Sherman D-CA-32
  • Adam Smith D-WA-9
  • Eric Sorensen D-IL-17
  • Melanie A. Stansbury D-NM-1
  • Greg Stanton D-AZ-4
  • Thomas R. Suozzi D-NY-3
  • Glenn Thompson R-PA-15
  • Mike Thompson D-CA-4
  • Rashida Tlaib D-MI-12
  • Paul Tonko D-NY-20
  • Ritchie Torres D-NY-15
  • Lauren Underwood D-IL-14
  • David G. Valadao R-CA-22
  • Jefferson Van Drew R-NJ-2
  • Marc A. Veasey D-TX-33
  • Eugene Simon Vindman D-VA-7
  • Tim Walberg R-MI-5
  • Bonnie Watson Coleman D-NJ-12
  • Randy K. Weber, Sr. R-TX-14
  • George Whitesides D-CA-27
  • Joe Wilson R-SC-2
  • Robert J. Wittman R-VA-1
  • Steve Womack R-AR-3