S-4472 — Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

YourVoice.Now Summary

Your MoneyTransparency & Accountability

People with ALS could keep getting drugs still in testing — five more years, with new safety reports.

Your Money

ALS drug access outside clinical trials — funding allowed through 2031

The law that allows this funding ends after 2026. The bill would let it run for five more years, through fiscal year 2031. The program helps people with ALS get drugs that are still being tested, outside a clinical trial.

Drugs that qualify for ALS access — more trial types count

The program's rules turn on whether a drug is in a phase 3 trial, the last big testing stage. Combined phase 2/3 trials would also count. So would planned phase 3 trials that have not started enrolling, if enrollment begins by a deadline the government sets.

Transparency & Accountability

Safety reports from ALS drug trials — must reach the government promptly

Anyone getting one of these grants would have to promise to send the government safety findings from any ongoing trial of the drug. The promise would be written into the grant's terms.

Safety data checked before ALS grants are renewed

Before renewing a grant, the government would have to ask the drug's maker for data. That means enrollment numbers, safety findings, and any results showing whether the drug works. It would then have to review what it gets.

Public FDA plan for rare brain-and-nerve diseases — updated every five years

The FDA would have to publish an updated plan within a year. After that, a new plan would come every five years. The plan sets out how the agency will help bring drugs to people with ALS and other rare brain-and-nerve diseases.

Public accounting for the FDA's last ALS plan — progress and roadblocks

Each new plan would have to describe what the FDA did under the plan before it, and what else it means to do. It would also have to name what is getting in the way. The agency may add an estimate of what it would cost to fix that.

Reviews of whether ALS programs work — two reports ordered

The GAO, Congress's watchdog office, would have to report again on these programs. Health and Human Services would owe Congress its own report within four years. It would have to say whether the programs work and how to make them better.

More about this bill

If you or someone close to you has ALS, a program that helps people get drugs still in testing would keep going. The law behind it runs out after 2026. It would be renewed for five more years, through fiscal year 2031. The program pays for "expanded access" — trying a drug that is still being tested, outside a clinical trial. The grant rules would also get tighter. Grant holders would have to report safety findings from ongoing trials right away. Before renewing a grant, the government would have to get enrollment and safety data from the drug's maker. It would have to review that data, not just collect it. Applicants would also have to explain how the grant's data would help ALS research. More trials would count as well, including combined phase 2/3 trials and planned phase 3 trials that have not started enrolling. Public reporting would grow too. The FDA would publish an updated plan for ALS and other rare brain-and-nerve diseases within a year, then every five years. Each plan would have to say what the agency did under the last one. It would also have to name what is blocking progress. Two reviews would be ordered as well: one by the GAO, Congress's watchdog office, and one by Health and Human Services within four years.

Congressional Summary

Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 This 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 reauthorizes grants 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, and a Public-Private Partnership including the FDA and NIH that supports development and regulatory review of treatments for neurodegenerative diseases. Also, the bill revises the NIH grants to require (1) the NIH, in considering grant renewal, to assess available information on the safety and efficacy of the investigational drugs; (2) grantees to promptly report available safety data from ongoing clinical trials; and (3) the NIH to determine the timeframe for enrollment in clinical trials for the investigational drugs. Additionally, every five years, 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, for ALS and other rare neurodegenerative diseases. Each plan must include the FDA's previous actions and recommendations for improvements. Finally, the Government Accountability Office and the Department of Health and Human Services must report on the impacts of these grants.

Legislative Subjects

Department of Health and Human ServicesDrug therapyFood and Drug Administration (FDA)Government information and archivesHealth programs administration and fundingInternet, web applications, social mediaMedical researchNational Institutes of Health (NIH)Neurological disordersPublic-private cooperationResearch administration and funding

Details

Congress: 119th
Chamber: Senate
Status: summarized
Action: Passed Senate
Action Date: 2026-08-04
Date Added: 2026-07-28
Source: Congress.gov →

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