Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
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Progress
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- Introduced
- Passed Senate
- Passed House
- To President
- Became Law
Overview
This bill reauthorizes the Accelerating Access to Critical Therapies for ALS Act, extending its provisions through 2031. It makes several key changes to the program, including requiring the Food and Drug Administration to review the status of clinical trials for investigational ALS drugs and to publish a report on the agency’s plans for rare neurodegenerative diseases. The bill also extends the timeframe for the Government Accountability Office’s report on the Act’s implementation.
Key provisions
- Extends the Accelerating Access to Critical Therapies for ALS Act through fiscal year 2031.
- Requires the Secretary of Health and Human Services to assess the status of clinical trials when reviewing grant renewals for ALS therapies.
- Mandates the sharing of interim clinical trial data from drug manufacturers with the FDA.
- Expands the definition of ‘phase 3’ clinical trials to include combined phase 2/3 trials and planned phase 3 trials not yet enrolling participants.
- Directs the FDA to publish a report on its action plan for rare neurodegenerative diseases, including updates to the 2022 Action Plan.
- Extends the timeframe for the Government Accountability Office’s report on the Act’s implementation.
- Specifies the reporting period for the GAO report to be 5 years after the enactment of the reauthorization act.
Who is affected
- People with Amyotrophic Lateral Sclerosis (ALS)
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16 on record
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