Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
- Bill Number
- S. 4472
- Origin Chamber
- Senate
- Congress
- 119th Congress, Session 2
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2026-06-17: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- Last Updated
- 2026-06-25T12:18:24Z
AI-Generated Summary
Purpose of the Legislation
This bill reauthorizes and updates the Accelerating Access to Critical Therapies for ALS Act (Public Law 117-79) to extend support for research and access to therapies for amyotrophic lateral sclerosis (ALS) and related rare neurodegenerative diseases through fiscal year 2031. It aims to sustain funding and improve program oversight for developing treatments.
Key Provisions
- Reauthorization: Extends the overall Act and specific grants for ALS research from 2026 to 2031.
- Grant Program Improvements:
- Requires the Secretary of Health and Human Services to review clinical trial enrollment data when considering grant renewals for investigational drugs.
- Mandates that manufacturers share interim clinical trial data to support these reviews.
- Clarifies that "phase 3" clinical trials include phase 2/3 combined trials and planned phase 3 trials not yet enrolling participants.
- New Reporting Requirement: Directs the Commissioner of Food and Drugs to publish a report within one year of enactment, including an updated five-year action plan for ALS and other rare neurodegenerative diseases, resource needs, and coordination with affected communities. The report must also assess the 2022 Action Plan for Rare Neurodegenerative Diseases, covering actions taken, effects on therapy development, programs established, and coverage of non-ALS conditions.
- GAO Report Adjustment: Changes the Government Accountability Office report deadline to five years after this bill's enactment and limits its scope to a 10-year period starting from the original Act's enactment.
Significant Changes to Existing Law
- Updates the expiration date in Section 7 and Section 2(f) of the original Act from 2026 to 2031.
- Adds new subsections to the grant program (Section 2(b) and 2(e)) for clinical trial oversight and definition clarifications.
- Introduces a new subsection (c) to Section 4 requiring detailed FDA reporting on action plans.
- Modifies the timing and content requirements in Section 6 for the GAO report.
Potential Impacts
- On Government Agencies: Extends FDA and HHS responsibilities for grant administration, data reviews, and reporting, potentially requiring additional resources for implementation and coordination.
- On Citizens: May support continued development of ALS therapies, benefiting patients and families by sustaining research access programs.
- On International Relations: No direct provisions affect international matters, as the focus remains on U.S. domestic health policy and regulatory processes.
Main Stakeholders Affected
- Patients with ALS and other rare neurodegenerative diseases, along with their families and advocacy groups.
- Pharmaceutical manufacturers developing investigational drugs for these conditions.
- The Food and Drug Administration and Department of Health and Human Services, responsible for program oversight and reporting.
- Researchers and clinical trial participants involved in ALS therapy development.
- The Government Accountability Office, tasked with evaluation.
Notable Legal, Constitutional, or Political Implications
- The bill operates within existing federal health authority under the Food, Drug, and Cosmetic Act, with no apparent constitutional challenges as it involves standard reauthorization and reporting mandates.
- It emphasizes expanded oversight of clinical trials and broader inclusion of rare diseases, which could influence regulatory policy without altering core legal frameworks.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (11)
Sen. Coons, Christopher A. [D-DE], Sen. Collins, Susan M. [R-ME], Sen. Klobuchar, Amy [D-MN], Sen. Padilla, Alex [D-CA], Sen. Capito, Shelley Moore [R-WV], Sen. Curtis, John R. [R-UT], Sen. Gillibrand, Kirsten E. [D-NY], Sen. Hassan, Margaret Wood [D-NH], Sen. Banks, Jim [R-IN], Sen. Markey, Edward J. [D-MA], Sen. Daines, Steve [R-MT]
Recent Actions
- 2026-06-17: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- 2026-04-30: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 2026-04-30: Introduced in Senate
Bill Versions
- Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 — issued 2026-04-30 — PDF (5 pages)