Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

Apr 30, 2026
Apr 30, 2026

Summary

Continues government programs that support research and access to new treatments for Amyotrophic Lateral Sclerosis (ALS) through the year 2031.

What problem does this solve?

The law that helps find new treatments for ALS is set to end in 2026, which would stop important research. This bill extends the law until 2031, making sure that work to find a cure continues.

What does this bill do?

Extends ALS therapy program until 2031
Continues the Accelerating Access to Critical Therapies for ALS Act for five more years, from 2026 to 2031.
Continues grants for ALS research
Extends the authorization for grants for research on therapies for ALS through fiscal year 2031.
Adds new review for clinical trials
Requires the Secretary to check on the patient enrollment status of clinical trials when reviewing grant renewals and to request interim data from drug makers.
Requires FDA to publish an action plan
Directs the Food and Drug Administration to publish an updated 5-year action plan for ALS and other rare neurodegenerative diseases within one year.
Updates timeline for GAO report
Changes the deadline for a Government Accountability Office report on the program to 5 years after this new act passes.
Clarifies 'phase 3' clinical trial definition
Expands the definition of a 'phase 3' clinical trial to include combined phase 2/3 trials and planned phase 3 trials not yet enrolling patients.

Who does this affect?

  • Patients with ALS
  • Medical Researchers
  • Pharmaceutical Companies

What is the real world impact?

Ensures continued support for ALS patients
Extends a program that helps speed up the development of treatments for ALS, a fatal disease with no cure. It provides stability for ongoing research projects and patient access programs.

When does this start?

This bill contains multiple deadlines for government agencies to complete specific actions.
FDA action plan report
The Food and Drug Administration must publish its updated action plan on its website no later than one year after this bill becomes law.
GAO program report
The Government Accountability Office must submit a report on the program's progress within 5 years after this bill becomes law.