S. 4472: Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

S. 4472 would keep the federal ALS expanded-access and research program alive for 5 more years, through 2031.

That matters because the program is meant to help people with ALS reach investigational therapies before the normal approval process is over. The bill also extends ALS research grants over the same period.

But this is not just a clean extension. Applicants would have to explain how the data collected from expanded access will support ALS research or drug development, not just patient access alone.

The tradeoff is straightforward: patients keep a path to experimental treatment, while Congress requires more safety reporting, faster enrollment, and more follow-up data in return.

Grant recipients would have to promptly report available safety data from any ongoing clinical trial of the same drug. If a grant is being renewed, federal officials would also have to review enrollment, safety, and any available efficacy data from the drug sponsor before continuing support.

The bill also widens the pool of therapies that can qualify. A combined phase 2/3 trial would count, and even a planned phase 3 trial that has not started enrolling yet could fit the program.

It also sets a clock on the bureaucracy: funded projects must start enrolling patients on time, FDA must update its action planning within 1 year, and HHS must report back to Congress within 4 years on whether the program is actually working.

Most of the rest is oversight and cleanup, including recurring FDA updates every 5 years and a small technical correction to the underlying ALS law.