What This Bill Does
This bill would extend the Accelerating Access to Critical Therapies for ALS Act from 2026 to 2031 and make several changes to how ALS research grants are reviewed and reported on. It directs the Secretary of Health and Human Services to look at interim clinical trial data when reviewing renewal grants tied to investigational drugs and broadens the definition of a qualifying phase 3 trial to include phase 2/3 combined trials and planned phase 3 studies that have not yet started enrolling. It also requires the FDA to publish an updated ALS and rare neurodegenerative disease action plan report within one year and pushes the GAO reporting deadline out to five years after enactment.
- Extends the ALS law's authorization from 2026 to 2031.
- Requires clinical trial enrollment status review for grant renewals tied to investigational drugs.
- Directs the Secretary to request interim clinical trial data from manufacturers.
- Expands "phase 3" to include phase 2/3 combined trials and planned phase 3 trials not yet enrolling.
- Requires an FDA report within 1 year on ALS and other rare neurodegenerative disease action plans.
Who This Bill Affects
For someone with ALS, a family caregiver, or a researcher working on ALS treatments, this bill would extend federal support through fiscal year 2031 and could make grant renewals more data-informed by requiring interim clinical trial data and review of patient enrollment status. It may also broaden access to the program by counting phase 2/3 combined trials and planned but not-yet-enrolling phase 3 trials as qualifying phase 3 studies. For the general public, the direct effect is limited, but the bill could influence the pace and oversight of ALS therapy development.
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- ALS patients and family caregivers Supporters are likely to value a longer federal commitment to ALS research and therapy development. The extension through 2031 and the new reporting requirements signal continued attention to a disease with few effective treatment options.
- Clinical researchers and drug developers They may support clearer grant rules and a broader definition of phase 3 trials because it can help more studies qualify and align federal support with the real pace of clinical development. The updated FDA action plan report may also create a clearer roadmap for research priorities.
- Rare-disease advocates They may favor the requirement that FDA describe coordination with rare neurodegenerative disease communities beyond ALS. That could help spread lessons from ALS policy to related conditions that face similar development barriers.
- Some biotechnology companies and grant recipients They may object to the requirement that manufacturers share interim clinical trial data, especially for renewal reviews, because it can increase disclosure burdens and potentially reveal sensitive trial information earlier than they would prefer.
- Fiscal conservatives They may question extending the program to 2031 and adding additional reporting obligations if they see the law as creating long-running federal commitments with limited reach beyond a small patient population.
- Some patient privacy or trial confidentiality advocates They may worry that more data-sharing around interim clinical trial results could increase the risk of disclosing information that companies consider proprietary or that could be misunderstood before trials conclude.
Key Implications
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“"the Secretary shall request that the manufacturer ... share interim clinical trial data"”
This gives the federal government more real-time information when deciding whether to renew an ALS research grant, which could improve oversight. It also places an added burden on manufacturers participating in the program.
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“"the term 'phase 3' ... includes a phase 2/3 combined trial"”
This broadens eligibility so that certain hybrid trials can count as phase 3 for purposes of the ALS grant program. That can matter for studies that are close to late-stage testing but do not fit a narrow definition.
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“"striking '2026' and inserting '2031'"”
This pushes the existing ALS law's expiration date back five years, preserving the grant and program structure longer. People involved in ALS research would continue to have access to the same federal framework through fiscal year 2031.
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“"publish ... a report that contains an updated action plan"”
The FDA would have to publicly explain its next five years of ALS and related rare-disease work, including resources needed and coordination with non-ALS communities. That creates a clearer public record of federal priorities and progress.
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“"5 years after the date of enactment"”
This delays the GAO's reporting deadline, giving more time to observe how the reauthorized program performs. The report is also tied to a 10-year period starting on enactment, which shapes what outcomes will be reviewed.
Latest Status
June 17, 2026
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
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