S.Amdt. 6206

This amendment, known as the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, aims to extend and improve the existing Accelerating Access to Critical Therapies for ALS Act.

Its primary purpose is to make the following changes:

• Reauthorization: It extends the act and grants for ALS research from the 2022-2026 period to the 2027-2031 period.

• Grant Improvements: It updates the program for research grants by:

  • Requiring a description of how data from expanded access grants will support the prevention, diagnosis, mitigation, treatment, or cure of ALS.
  • Requiring entities to promptly report available safety data from ongoing clinical trials to the Secretary.
  • Requiring the assessment of enrollment, safety, and efficacy data for grant renewals.
  • Requiring enrollment to begin within a timeframe determined by the Secretary.
  • Defining phase 3 clinical trial to include planned phase 3 trials not yet enrolling participants and combined phase 2/3 trials.

• Action Plan Updates: It requires the FDA to develop or update action plans for ALS and other rare neurodegenerative diseases every 5 years. New plans must describe previous actions taken, planned future actions, and any barriers to implementation, including resource estimates.

• Reporting: It adds a requirement for the Secretary of Health and Human Services to submit a report within 4 years assessing the effectiveness of activities under sections 2, 3, and 5 and providing recommendations for improvement.

• Technical Fixes: It corrects spelling errors for the words amyotrophic and rational.