H.R. 8205

Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

Sponsor: Mike Quigley

103 cosponsors
Follow this bill

Official summary

Written by the Congressional Research Service.

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.

Text of the bill

Collapse all
Sec. 1. Short title Since introduced

This Act may be cited as the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026.

Sec. 2. Reauthorization of Accelerating Access to Critical Therapies for ALS Act Changed · Jul 9

(a) In general. Section 7 of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117–79) is amended by striking 2026 and inserting 2031.

(b) Grants for ALS research. 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.

Sec. 3. Improvements to program for grants for research on therapies for ALS Changed · Jul 9

(a) Renewal of grants for research on therapies for ALS review. 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:

Text this section adds to the law

(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.

(b) Reporting safety data. Section 2(c) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended—

(1) in paragraph (2)(B), by striking and at the end;

(2) in paragraph (3), by striking the period at the end and inserting ; and; and

(3) by adding at the end the following:

Text this section adds to the law

(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).

(c) Clarifying participating clinical trial definition. 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:

Text this section adds to the law

(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.

Sec. 4. FDA rare neurodegenerative disease action plan Added Jul 9

Section 4 of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360aa note) is amended—

(1) in the section heading, by striking ALS and other rare neurodegenerative disease action plan and inserting FDA rare neurodegenerative disease action plan; and

(2) by adding at the end the following:

Text this section adds to the law

(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).