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

Where this section came from

Not in the first version (Introduced in House, Apr 6).

  1. 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 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.

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).