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

This section extends the authorization of the Accelerating Access to Critical Therapies for ALS Act through 2031 (from 2026). It also extends the period for grants supporting ALS research under the Act through 2031 (from 2026).

This section requires the Secretary to request and assess enrollment, safety, and efficacy data for an investigational ALS drug when reviewing applications to renew grants under the Accelerating Access to Critical Therapies for ALS Act. It also requires grant recipients to promptly report new and serious unexpected adverse events from phase 3 trials to the grant-making institution, and it defines phase 3 to include phase 2/3 combined trials that begin enrollment within a Secretary-determined timeframe.

This section renames the FDA rare neurodegenerative disease action plan and requires the Commissioner of Food and Drugs to publish on the FDA website, not later than 18 months after enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, an action plan describing intended actions over the following 5-year period on program enhancements, policy development, and regulatory science initiatives for rare neurodegenerative diseases. It also requires publication of a report not later than 5 years after enactment describing actions taken and the extent to which the plan meets its requirements.