Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
What does the S 4472 do?
S 4472 is a Senate bill sponsored by Sen. Lisa Murkowski (R-AK). The 2021 Accelerating Access to Critical Therapies for ALS Act (Public Law 117-79) created an FDA expanded-access grant program for investigational drugs to prevent, diagnose, mitigate, treat, or cure amyotrophic lateral sclerosis, and directed FDA to publish an action plan on ALS and other rare neurodegenerative diseases. Its authorization of appropriations ran through fiscal year 2026, per the fetched Public Law 117-79 text. This reauthorization extends the underlying statute — both the general 5-year authorization and the Section 2(f) sunset date on new expanded-access grant awards — through fiscal year 2031, adds a safety-reporting requirement for grantees, refines the criteria FDA considers when reviewing and renewing grants, updates the FDA action-plan cadence to every 5 years (with new content requirements about prior-plan implementation and barriers), narrows the action plan's scope from "ALS and other rare neurodegenerative diseases" to "FDA action plans," and adds a new 4-year HHS effectiveness report. Two technical fixes correct misspellings in the ALS statute.
Did S 4472 pass? Where it stands
As of August 24, 2026, S 4472 has passed the Senate.
Status: Passed Senate
Latest vote: Senate Passed by voice vote on August 4, 2026
Outlook: Likely
Key provisions
- 5-Year Reauthorization
- General authorization of appropriations extended from "2022 through 2026" to "2027 through 2031"
- Section 2(f) sunset on new expanded-access grant awards extended by striking "2026" and inserting "2031"
- Bill does not itself alter the authorization dollar level
- Grantee Safety Reporting
- Grantees must promptly report to the Secretary available safety data from any ongoing clinical trial of the investigational drug
- Reporting terms are set in the terms and conditions of the grant
- Grant Renewal Criteria
- On renewal of an expanded-access grant, the Secretary must request from the investigational new drug application sponsor — and assess — the enrollment, safety, and any available efficacy data of the drug
- Data considered relates to the prevention, diagnosis, mitigation, treatment, or cure of ALS
- FDA Action Plan Cadence and Content
- New requirement: action plan updated not later than 1 year after enactment of this reauthorization and every 5 years thereafter
- Section 4 heading narrowed from "ALS and other" to "FDA" action plans
- Each new plan must describe previous actions to implement the prior plan, planned actions to implement the current plan, and any barriers to implementation (with a possible resource estimate)
- New HHS Effectiveness Report
- Not later than 4 years after enactment, HHS must submit a report to Senate HELP and House Energy and Commerce
- Report assesses the effectiveness of activities under sections 2, 3, and 5 of Public Law 117-79
- Report makes recommendations to improve those activities without duplicating the FDA action plan
Last updated August 12, 2026