HR-8205 — Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

YourVoice.Now Summary

Your MoneyTransparency & Accountability

A program letting ALS patients try experimental drugs would run to 2031 — with tighter safety reporting.

Your Money

Experimental drug access for ALS patients — program runs through 2031

The law behind this program was set to run out in 2026. The bill pushes that date to 2031. The grants pay for people with ALS to get drugs still being tested, when they cannot join a trial.

Drugs ALS patients could try — earlier-stage trials now count

Grants are tied to drugs in a late-stage, or phase 3, trial. The bill also counts a combined phase 2/3 trial, if it starts signing up patients in time. Officials set that time limit.

Transparency & Accountability

Prompt reporting of unexpected serious harm — to the grant funder

Grant seekers already report bad reactions to the FDA. The bill adds one more duty. They must tell the group paying for the study, right away, when a new and serious problem shows up.

Safety checks at ALS grant renewal — including how well drugs work

Before renewing a grant, officials must ask the drug's maker for data on who enrolled, what harm showed up, and any sign the drug works. They must then review it.

FDA plan posted publicly — rare nerve diseases, within 18 months

Within 18 months of becoming law, the FDA must put a plan on its website. It has to say what the agency will do over the next five years for ALS and other rare nerve diseases.

FDA report on what it did — published within five years

Five years after the bill becomes law, the FDA must post a second document. It must say what the agency actually did under the plan, and whether it met what the law asked for.

More about this bill

If someone you love has ALS, this keeps a treatment door open. ALS, also called Lou Gehrig's disease, slowly takes away the ability to move, speak, and breathe. A federal program pays for people with ALS to try drugs that are still being tested. It is meant for patients who cannot get into a clinical trial. That program was set to end in 2026. It would now run through 2031. Most other people would see no change in daily life. The bill also widens which drugs can qualify, so some at an earlier stage of testing would count. At the same time, safety checks would tighten. Groups seeking these grants must promptly report serious, unexpected harm from a trial. Before a grant is renewed, officials must ask the drug maker for data and review it. The FDA would also have to post a public plan within 18 months. It must cover the agency's next five years of work on rare nerve diseases. A follow-up report on what it actually did is due within five years. The House passed the bill on July 22, 2026. The Senate has not voted.

Congressional Summary

Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026This bill reauthorizes through FY2031 and revises programs that support research and development of drugs and other therapies to address amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease) and other neurodegenerative diseases.The bill reauthorizesgrants from the National Institutes of Health (NIH) for scientific research on investigational drugs to prevent or treat ALS for individuals not otherwise eligible for clinical trials,grants from the Food and Drug Administration (FDA) for research and development of therapies to prevent and treat ALS and other neurodegenerative diseases, anda Public-Private Partnership including the FDA and NIH that supports development and regulatory review of treatments for neurodegenerative diseases. Also, the NIH, in considering renewal of its grants, must assess available information on the safety and efficacy of the investigational drugs. It must also require grantees to promptly report serious and unexpected adverse events associated with their investigational drugs.Additionally, the FDA must publish a plan describing actions it will take over a five-year period to foster development of safe and effective drugs, and facilitate access to investigational drugs, that treat ALS and other rare neurodegenerative diseases. The FDA must also publish a report describing the actions it has taken under the plan.

Details

Congress: 119th
Chamber: House
Status: summarized
Action: Reported to House
Action Date: 2026-07-09
Date Added: 2026-07-17
Source: Congress.gov →

Like reading a bill in plain English?

We're building an app that does this for every bill in Congress and lets you tell your reps how you want them to vote. We're a small team getting ready to launch, and we're trying to show investors that real people want this. Be one of them. Help us get it built. Leave your email and we'll tell you the moment the app is ready.