S. 4472 — Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

This section reauthorizes the Accelerating Access to Critical Therapies for ALS Act through 2031 (from 2026). It extends the period for grants for ALS research to 2031 (from 2026).

This section revises the expanded access grant program under the Accelerating Access to Critical Therapies for ALS Act. It requires grant applications to describe how data will support ALS research or development and to assure prompt reporting of safety data from ongoing clinical trials. It directs the Secretary to assess enrollment, safety, and efficacy data when considering grant renewals and expands the definition of phase 3 clinical trial to include phase 2/3 combined trials and planned phase 3 trials not yet enrolling.

This section requires the Food and Drug Administration to develop or update and publish an action plan for rare neurodegenerative diseases, including ALS, not later than one year after enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 and every five years thereafter. Each plan after the initial one must describe prior FDA actions taken, planned future actions, barriers to implementation, and related recommendations, including resource estimates.

This section requires the Secretary of Health and Human Services to submit a report to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce, not later than 4 years after enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, assessing the effectiveness of activities under sections 2, 3, and 5 of the Accelerating Access to Critical Therapies for ALS Act and recommending improvements. It also updates the existing GAO report reference to the reauthorization act.

This section corrects the spelling of “amyotrophic” in the statutory description of the Public-Private Partnership for Neurodegenerative Diseases and removes the word “rational” from the criteria for eligible entities under the Accelerating Access to Critical Therapies for ALS Act.