Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

This legislation reauthorizes the Accelerating Access to Critical Therapies for ALS Act, extending its provisions and grants for research into Amyotrophic Lateral Sclerosis (ALS) through fiscal year 2031 . The bill aims to ensure continued support for the development of critical therapies for this debilitating disease, with a Sense of Congress encouraging direct appropriations for the Act's implementation. This extension provides a longer-term framework for ongoing research and development efforts. The bill introduces significant improvements to the grant program for ALS research. It requires the Secretary to assess the clinical trial enrollment status of investigational drugs when reviewing grant renewals, requesting interim data from manufacturers to facilitate this assessment. Furthermore, it clarifies the definition of a "phase 3" clinical trial to include combined phase 2/3 trials and planned phase 3 trials that have not yet begun enrolling participants, thereby broadening the scope of eligible research and accelerating therapy development. New reporting requirements are also established to enhance transparency and accountability. The Food and Drug Administration (FDA) Commissioner must publish an updated action plan within one year, detailing future actions, necessary resources, and improved coordination with various rare neurodegenerative disease communities. Additionally, the Comptroller General is mandated to submit a report to Congress within four years, providing an analysis of the program's effectiveness and data as outlined in the original Act, ensuring comprehensive oversight.