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H.R. 8205

Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

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.

Presented to President.

Rep. Quigley, Mike [D-IL-5](D-IL)Sponsor
103 cosponsors64 D39 R
103cosponsors1committees25actions2related bills12subjects
  1. Calendars

    Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 466.

  2. FloorH38310

    Motion to reconsider laid on the table Agreed to without objection.

  3. FloorH37300

    On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.

  4. Floor8000

    Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.

  5. FloorH30000

    Considered as unfinished business. (consideration: CR H5159)

  6. FloorH37210

    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.

  7. FloorH8D000

    DEBATE - The House proceeded with forty minutes of debate on H.R. 8205.

  8. FloorH30000

    Considered under suspension of the rules. (consideration: CR H4652-4654; text: CR H4653)

  9. FloorH30300

    Mr. Guthrie moved to suspend the rules and pass the bill, as amended.

  10. CalendarsH12410

    Placed on the Union Calendar, Calendar No. 637.

  11. CommitteeH12200

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-733.

    Energy and Commerce Committee
  12. Committee5000

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-733.

    Energy and Commerce Committee
  13. Committee

    Ordered to be Reported (Amended) by the Yeas and Nays: 46 - 0.

    Energy and Commerce Committee
  14. Committee

    Committee Consideration and Mark-up Session Held

    Energy and Commerce Committee
  15. Committee

    Forwarded by Subcommittee to Full Committee by Voice Vote.

    Health Subcommittee
  16. Committee

    Subcommittee Consideration and Mark-up Session Held

    Health Subcommittee
  17. Committee

    Referred to the Subcommittee on Health.

    Health Subcommittee
  18. IntroReferralH11100

    Referred to the House Committee on Energy and Commerce.

    Energy and Commerce Committee
  19. IntroReferralIntro-H

    Introduced in House

  20. IntroReferral1000

    Introduced in House