Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed House
- Passed Senate
- To President
- Became Law
Overview
This bill reauthorizes the Accelerating Access to Critical Therapies for ALS Act through 2031, extending its support for research and access to treatments for Amyotrophic Lateral Sclerosis (ALS). It includes changes to improve the grant review process by requiring a review of clinical trial status and encouraging manufacturers to share interim data. The bill also directs the Food and Drug Administration to publish a report on its action plans for rare neurodegenerative diseases, including an update to the existing 2022 plan and an assessment of its impact.
Key provisions
- Extends the Accelerating Access to Critical Therapies for ALS Act through fiscal year 2031.
- Requires a review of clinical trial status when evaluating grant renewal applications for ALS therapies.
- Mandates manufacturers to share interim clinical trial data with the FDA.
- Clarifies the definition of ‘phase 3’ clinical trials to include combined phase 2/3 trials and planned phase 3 trials.
- Directs the FDA to publish a report on its action plans for rare neurodegenerative diseases, updating the 2022 plan.
- Requires the FDA report to assess the impact of the 2022 Action Plan and other initiatives.
- Instructs the GAO to submit a report analyzing data related to ALS research and treatment access.
Who is affected
- People with ALS and their families
- Researchers developing ALS therapies
- The Food and Drug Administration
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