H.R. 8205

Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

Sponsor: Mike Quigley

103 cosponsors
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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

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

Where this section came from

  1. Apr 6, 2026 · Introduced in House Referred to House Committee on Energy and Commerce, Apr 6
  2. Jul 9, 2026 · Reported in House Marked up by House Committee on Energy and Commerce, May 21 Reported by House Committee on Energy and Commerce, Jul 9 Committee members' individual votes aren't in our records.
What changed in the text

(a) Clinical Renewal trial of status 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:

[Inserted into the law:

(4) Clinical Renewal trial of status grants review. for (A) research In on general 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 assess request from the status manufacturer of or a sponsor, clinical and trial assess, carried the out for such drug with respect to data on enrollment , of safety, patients and in any such available clinical efficacy trial. (B) Interim clinical trial data . To relating enable the Secretary to make the assessment under subparagraph (A) with respect to an investigational drug , in the Secretary prevention, shall diagnosis, request mitigation, that treatment, the or manufacturer cure of the amyotrophic investigational lateral drug share interim clinical trial data with respect to such drug with the Secretary sclerosis .

]

(b) Clarifying Reporting participating safety clinical trial definition data . Section 2( e 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:

[Inserted into the law:

(4) The the term entity phase seeking 3, such grant will promptly report any new and serious adverse events and safety information that is considered to be unexpected with respect to a the clinical phase 3 trial to the grant-making institution , includes in a addition phase to 2/3 complying combined with trial the and safety a reporting planned requirements phase under 3 section clinical 312.32 trial of that title is 21, not Code yet of enrolling Federal participants. 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:

[Inserted into 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.

]

What is a markup?

A markup is a committee meeting where members go through a bill and vote on changes before sending it to the full chamber.

(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.