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Part ofALS
HR8205FEDERALin_committee
High Impact

Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

April 6, 2026

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Where This Stands

Introduced
Committee
Floor Vote
Passed
Signed

Currently in_committee. The next step in the legislative lifecycle is Floor Vote.

Last action
Ordered to be Reported (Amended) by the Yeas and Nays: 46 - 0.May 21, 2026

Version history

Only one version on file - nothing to compare yet. As later stages (committee substitute, engrossed, enrolled) are captured, the redline appears here.

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The Frame

What this does

This legislation ensures the continuation of federal ALS research grants and regulatory programs through 2031, impacting the timeline for drug development and the availability of clinical trial data for patients and researchers.

Who is mentioned in the record

Potentially affected actors named in the source documents. Mention is not a position.

ALS patients and families

The bill dictates the timeline and regulatory framework for research into therapies for their condition.

Pharmaceutical manufacturers

Companies conducting ALS clinical trials must share interim data with the FDA to qualify for grant renewals.

Food and Drug Administration

The agency is tasked with new reporting requirements and oversight duties regarding clinical trial data.

What changed

Current stage: in_committee.

What's next

Floor Vote.

Summary

This bill extends federal funding and research programs for Amyotrophic Lateral Sclerosis (ALS) through 2031. It also introduces new requirements for clinical trial data sharing and mandates a comprehensive FDA report on progress in treating rare neurodegenerative diseases.

Key Facts

  • Extends the authorization of the Accelerating Access to Critical Therapies for ALS Act from 2026 to 2031.
  • Requires the FDA to assess clinical trial enrollment data when reviewing grant renewal applications for investigational drugs.
  • Mandates that manufacturers share interim clinical trial data with the FDA to facilitate grant renewal assessments.
  • Expands the definition of 'phase 3' clinical trials to include combined phase 2/3 trials and planned trials not yet enrolling participants.
  • Requires the FDA Commissioner to publish an updated action plan for ALS and other rare neurodegenerative diseases within one year of enactment.
  • Requires the FDA to report on the implementation and outcomes of the 2022 Action Plan for Rare Neurodegenerative Diseases.
  • Mandates a GAO report on the program's progress to be submitted to Congress within four years of enactment.
  • Expresses a Sense of Congress that funds should be directly appropriated to carry out the Act's provisions.

Why It Matters

This legislation ensures the continuation of federal ALS research grants and regulatory programs through 2031, impacting the timeline for drug development and the availability of clinical trial data for patients and researchers.

Frequently Asked Questions

How long will this program be extended?
The provisions of the Act are extended through fiscal year 2031.
What new information must drug manufacturers provide?
Manufacturers seeking grant renewals must share interim clinical trial data with the FDA so the agency can assess patient enrollment status.
When will the public see a report on these efforts?
The FDA must publish an updated action plan and report on the 2022 Action Plan within one year of the bill's enactment.

News Coverage

No news coverage found yet. Articles are indexed twice daily.

Sponsors

Discoveries

Patterns POLISCOPE noticed across the record. These are observations to investigate, not conclusions.

policy shift95% confidence

Increased Data Transparency

The bill shifts from simple funding authorization to requiring active sharing of interim clinical trial data between manufacturers and the FDA.

Connected Entities

personMr. CalvertMember of the House of Representatives who co-sponsored the bill.Map →
organizationFood and Drug AdministrationResponsible for implementing research programs and publishing the required actioMap →
personMr. QuigleyMember of the House of Representatives who introduced the bill.Map →
organizationGovernment Accountability OfficeRequired to submit a report on the program's progress within four years.Map →

Analysis Score

0–100
  • Significance75
    How much this matters to a regular citizen
  • Controversy10
    Intensity of disagreement among stakeholders
  • Entertainment5
    Compellingness for a non-policy-wonk reader
  • Buzz20
    Current news / social attention level

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