Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

The reauthorization window was clarified from simply extending to 2031 to explicitly covering fiscal years 2027 through 2031 (replacing 2022 through 2026).

The FDA action plan report was changed from a one-time requirement to a recurring obligation: an initial report within one year of enactment and updated reports every five years thereafter, with each subsequent plan required to describe previous actions taken, planned actions, and barriers with resource estimates.

The GAO report deadline was changed from four years after enactment of the original Act to five years after enactment of this Reauthorization Act of 2026, and the section was restructured into separate GAO and HHS report subsections.

Grant applications must now include a description of how data generated through the expanded access grant will be used to support ALS research or development, and an assurance that the entity will promptly report available safety data from any ongoing clinical trial of the investigational drug.

For grant renewals, the Secretary must now request from the sponsor and assess enrollment, safety, and any available efficacy data of the drug related to ALS prevention, diagnosis, mitigation, treatment, or cure.

The definition of phase 3 clinical trial was moved into the statutory definitions section and a new requirement was added that a phase 3 trial must begin enrollment within a timeframe determined by the Secretary through grant terms and conditions.

A new HHS report is required within four years of enactment, in which the Secretary of Health and Human Services must submit to the Senate HELP Committee and House Energy and Commerce Committee an assessment of the effectiveness of activities under sections 2, 3, and 5, with recommendations for improvement.

A new Section 6 makes two technical corrections: fixes the typo 'amytrophic' to 'amyotrophic' in Section 3(a) and removes the stray word 'rational' from Section 3(b)(3)(A)(iii).