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H.R. 8205: Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

This bill, known as the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, aims to extend the provisions of the Accelerating Access to Critical Therapies for ALS Act until the fiscal year 2031. Here are the key points regarding what the bill will do:

1. Extension of Provisions

The bill amends certain sections of the original Accelerating Access to Critical Therapies for ALS Act by changing the expiration date from 2026 to 2031 for the following:

Grants for research related to Amyotrophic Lateral Sclerosis (ALS).
Other relevant provisions supporting clinical research and therapies for ALS.

2. Support for Grant Applications

The bill emphasizes that the committee in charge expresses support for appropriating funds for the implementation of all sections under the Accelerating Access to Critical Therapies for ALS Act. This indicates a push for financial backing to advance ALS research and treatment initiatives.

3. Improvements to Research Programs

The bill introduces enhancements to how grants for ALS research are managed:

The Secretary in charge will review grant applications by assessing the clinical trial status of investigational drugs, particularly looking at patient enrollment data.
Manufacturers of investigational drugs will be required to share interim clinical trial data with the Secretary to support this assessment.

4. Definition Clarification

The bill clarifies the definition of participating clinical trials to include:

Phase 2/3 combined trials.
Planned phase 3 clinical trials that have not yet started enrolling participants.

5. Reporting Requirements

Within one year of the bill's enactment, the Commissioner of Food and Drugs must publish a report on the Food and Drug Administration's (FDA) website that includes:

An updated action plan for ALS and other rare neurodegenerative diseases, including actions to be taken, necessary resources, and coordination efforts.
A review of the previously established action plan for rare neurodegenerative diseases, detailing actions taken, impacts on therapy development, and ongoing initiatives.

6. GAO Report

Four years after the enactment of this bill, a report will be submitted by the Comptroller General of the United States. This report will analyze data as outlined in the original Accelerating Access to Critical Therapies for ALS Act.

Relevant Companies

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This is an AI-generated summary of the bill text. There may be mistakes.

Actions

7 actions

Date	Action
May. 21, 2026	Committee Consideration and Mark-up Session Held
May. 21, 2026	Ordered to be Reported (Amended) by the Yeas and Nays: 46 - 0.
May. 13, 2026	Forwarded by Subcommittee to Full Committee by Voice Vote.
May. 13, 2026	Subcommittee Consideration and Mark-up Session Held
Apr. 06, 2026	Introduced in House
Apr. 06, 2026	Referred to the House Committee on Energy and Commerce.
Apr. 06, 2026	Referred to the Subcommittee on Health.

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