Congress could protect access to emerging ALS therapies by reauthorizing the ACT for ALS law before its Sept. 30, 2026 deadline, preserving $100 million a year that helped build research and clinical infrastructure for a disease affecting nearly 35,000 Americans. The push comes as the FDA opens path for faster ALS drug development through novel surrogate endpoints, raising the stakes for clinicians and patients who face a typical survival of just three to five years after diagnosis.

The Move

• Lawmakers are being urged to pass the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 before current funding expires.

• The original ACT for ALS authorized $100 million annually through 2026 to speed drug development, expand access to promising investigational therapies, and support public-private partnerships.

• If Congress does not renew the law, advocates warn that ongoing research, trial infrastructure, and treatment access efforts could be disrupted.

Why It Matters for Care

• ALS remains a rapidly progressive, terminal disease with fewer than a handful of approved treatment options and a usual survival of three to five years after diagnosis.

• For bedside care, faster trial enrollment and sustained access pathways could give eligible patients earlier opportunities to receive investigational or newly approved therapies.

• Clinicians may also benefit from a more durable research network that broadens where patients can be referred for studies and specialty treatment.

Between the Lines

• ALS has lagged behind areas like cancer and HIV in translating unmet need into a steady stream of drug approvals, despite its severity and speed.

• What is unusual here: science, FDA regulatory flexibility, and bipartisan political support are moving in the same direction at once.

• The broader policy fight is whether Congress will match the FDA’s evolving openness to biomarker-based and surrogate-endpoint approaches with sustained funding and statutory support.

What to Watch

• The key deadline is Sept. 30, 2026, when ACT for ALS funding expires absent reauthorization.

• Watch whether Congress advances the reauthorization bill during ALS Awareness Month and the 2026 legislative calendar.

• Also watch for further FDA action on surrogate endpoints in neurodegenerative disease and whether additional ALS therapies move toward accelerated review.

Source: RealClearHealth