This legislation reauthorizes the Accelerating Access to Critical Therapies for ALS Act, extending its provisions and funding for grants for ALS research through fiscal year 2031 . It also adjusts the timing for a Government Accountability Office (GAO) report , requiring it 5 years after this reauthorization's enactment, covering a 10-year period from the original Act. The bill introduces improvements to the grant program by requiring the Secretary to assess patient enrollment data in clinical trials when reviewing grant renewals for investigational drugs, with manufacturers sharing interim data. It also clarifies the definition of a "phase 3" clinical trial to include combined phase 2/3 trials and planned phase 3 trials not yet enrolling participants. A significant provision mandates that the Commissioner of Food and Drugs publish a report within one year, including an updated 5-year action plan for program enhancements and regulatory initiatives concerning ALS and other rare neurodegenerative diseases. This report must detail necessary resources, coordination with affected communities, and review actions taken under the 2022 Action Plan and its impact on therapy development.
Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
USA119th CongressS-4472| Senate
| Updated: 4/30/2026
This legislation reauthorizes the Accelerating Access to Critical Therapies for ALS Act, extending its provisions and funding for grants for ALS research through fiscal year 2031 . It also adjusts the timing for a Government Accountability Office (GAO) report , requiring it 5 years after this reauthorization's enactment, covering a 10-year period from the original Act. The bill introduces improvements to the grant program by requiring the Secretary to assess patient enrollment data in clinical trials when reviewing grant renewals for investigational drugs, with manufacturers sharing interim data. It also clarifies the definition of a "phase 3" clinical trial to include combined phase 2/3 trials and planned phase 3 trials not yet enrolling participants. A significant provision mandates that the Commissioner of Food and Drugs publish a report within one year, including an updated 5-year action plan for program enhancements and regulatory initiatives concerning ALS and other rare neurodegenerative diseases. This report must detail necessary resources, coordination with affected communities, and review actions taken under the 2022 Action Plan and its impact on therapy development.