Congress Passes ACT for ALS Reauthorization, Extending Research Programs

Congress has passed the Accelerating Access to Critical Therapies (ACT) for ALS Reauthorization Act of 2026, a measure that would extend key amyotrophic lateral sclerosis (ALS) research and investigational treatment access programs through fiscal year 2031. The legislation was sent to the president for signature following congressional passage.¹

"We must accelerate research and technology to help make ALS livable and cure it," said Calaneet Balas, president and CEO of the ALS Association, in a statement.¹ "ACT for ALS invests in that research, and it gives some people who can't join clinical trials a path to investigational therapies. Today, Democrats and Republicans came together to keep that progress going."

The reauthorization builds on the original ACT for ALS Act, enacted in 2021 to accelerate the development of ALS therapies and expand access to investigational treatments for individuals who may not qualify for clinical trials. The legislation extends the authorization period for the act's programs and grants supporting ALS therapeutic research through 2031.¹

Under the reauthorization, the research grant program would include additional requirements for reviewing grant renewals associated with investigational drugs, including assessments of patient enrollment, safety, and available efficacy data. The legislation also includes provisions intended to strengthen oversight of expanded access grants and improve transparency around investigational therapies.¹

The measure also addresses the US Food and Drug Administration's (FDA) work on rare neurodegenerative diseases. Provisions in the legislation call for the FDA to develop or update an action plan outlining regulatory and scientific initiatives related to these diseases, with subsequent reporting on the agency's implementation efforts.¹

The ALS Association supported the reauthorization through advocacy efforts involving individuals living with ALS, families, and bipartisan congressional partners. ACT for ALS was designed to help address challenges in developing treatments for a progressive neurodegenerative disease that affects motor neurons in the brain and spinal cord. As ALS progresses, individuals can experience worsening muscle weakness and loss of motor function, including difficulties with speaking, swallowing, and breathing. Although approved therapies are available, treatment options remain limited, underscoring the need for additional approaches that can slow disease progression and improve clinical outcomes.

The reauthorization would maintain federal support for ALS therapeutic research and expanded access programs through 2031. Its impact will depend in part on implementation, continued research progress, and the generation of evidence needed to establish the safety and efficacy of investigational treatments.

REFERENCES
1. The ALS Association Helps Secure Landmark Reauthorization of ACT for ALS. ALS Association. News Release. September 29, 2026. Accessed September 30, 2026. https://www.als.org/stories-news/als-association-helps-secure-landmark-reauthorization-act-als-0