Drugs

Accelerating ALS Therapies Act Heads to President’s Desk

David McFarland

— 1 min read
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The Senate has approved a House version of Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 (HR 8205) by unanimous consent. The bill, which extends the original ACT for ALS programs through fiscal year 2031 to maintain funding and access to investigational treatments, now heads to president Trump’s desk for his signature. The timing was critical because the current program was set to expire 9/30.

Key provisions of the legislation:

  • Program Extension: Reauthorizes NIH and FDA grants, along with public-private partnerships, through 9/2031.
  • Expanded Access Programs (EAPs): Continues pathways for patients ineligible for conventional clinical trials to receive promising investigational therapies while generating real-world clinical data.
  • FDA Action Plans: Requires FDA to publish a new five-year action plan outlining regulatory science initiatives and program enhancements no later than 18 months after enactment.
  • Accountability and Oversight: Mandates ongoing safety and efficacy assessments, clinical trial status reviews, and transparent adverse event reporting.

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