What does REAUTHORIZATION OF ACCELERATING ACCESS TO CRITICAL THERAPIES of Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 do?

This section reauthorizes portions of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117-79). Section 7 of the Accelerating Access to Critical Therapies for ALS Act has its expiration date extended from 2026 to 2031. Section 2(f) of the Accelerating Access to Critical Therapies for ALS Act also has its expiration date extended from 2026 to 2031. The Committee on Energy and Commerce of the House of Representatives supports the direct appropriation of funds to carry out the Accelerating Access to Critical Therapies for ALS Act.

What does IMPROVEMENTS TO PROGRAM FOR GRANTS FOR RESEARCH ON THERAPIES of Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 do?

This section amends the Accelerating Access to Critical Therapies for ALS Act. It modifies Section 2(b) to require the Secretary to assess the status of clinical trials, including patient enrollment data, when reviewing grant renewals for investigational drugs. The Secretary is authorized to request interim clinical trial data from the manufacturer of the investigational drug. It modifies Section 2(e) to clarify the definition of 'phase 3' clinical trials, including combined phase 2/3 trials and planned phase 3 trials not yet enrolling participants.

What does REPORT ON ALS AND OTHER RARE NEURODEGENERATIVE DISEASE ACTION of Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 do?

This section amends the Accelerating Access to Critical Therapies for ALS Act to require a report on ALS and other rare neurodegenerative disease action plans. The Commissioner of Food and Drugs must publish a report on the FDA website within one year of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026. The report must include an updated action plan detailing FDA actions over a 5-year period, resource needs, and coordination with neurodegenerative disease communities. The report must also describe actions taken under the 2022 Action Plan for Rare Neurodegenerative Diseases including ALS, its effect on therapy development, and implementation status. The updated action plan must include program enhancements, policy development, regulatory science initiatives, and other appropriate initiatives.

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Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

Q: What does Preamble of Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 do?

This bill amends the Accelerating Access to Critical Therapies for ALS Act. The bill reauthorizes the provisions of the Accelerating Access to Critical Therapies for ALS Act through fiscal year 2031. The bill is introduced by Mr. Quigley and Mr. Calvert and referred to the Committee on Energy and Commerce.

Q: What does SHORT TITLE. of Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 do?

This bill is formally titled the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026.

Q: What does GAO REPORT. of Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 do?

This section requires the Comptroller General of the United States to submit a report to specified congressional committees. The report must be submitted within four years of the Act's enactment. The report's content should include analyses and data described in section 6 of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117-79).

Last updated: 4/6/2026 · Introduced: 4/6/2026

Author: Mike Quigley (D-IL)

TL;DR (AI)

This bill extends the authorization of key provisions within the Accelerating Access to Critical Therapies for ALS Act through fiscal year 2031.
It requires the Secretary to evaluate clinical trial progress, including patient enrollment, when reviewing grant renewals for investigational drugs and authorizes requests for interim data.
The bill mandates a report from the FDA detailing actions, resource needs, and coordination efforts related to ALS and other rare neurodegenerative diseases over a five-year period.

119th Congressin committeeOfficial page

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