YourVoice.Now Summary
Average Household ImpactTransparency & AccountabilityExtends through 2031 the program paying for people with ALS to get experimental drugs outside clinical trials.
Average Household Impact
- Expanded access grants for ALS — Program extended through fiscal year 2031
Transparency & Accountability
- Safety data reporting — Grantees must promptly report available safety data from ongoing trials
- Renewal review — Enrollment, safety, and efficacy data must be assessed before a grant is renewed
- FDA action plan updates — Republished within a year and every 5 years, with barriers and resource needs
- Reporting requirements — A new HHS effectiveness report is added alongside the GAO review
The details
ACT for ALS, the 2021 law that pays for people with ALS to receive experimental drugs outside of clinical trials, runs out after 2026. Its expanded access grants and research grants would continue through 2031. ALS is a progressive nerve disease with no cure, and most patients do not qualify for the trials testing new treatments. The renewal adds conditions. Grant applicants must explain how the data they collect will advance ALS research. They must promptly hand over safety data from ongoing trials. Before renewing a grant, the government must review enrollment, safety, and any efficacy data. The FDA would also refresh its rare neurodegenerative disease action plan within a year, and every five years after. Each update must say what the agency has done, what it plans next, and what is blocking progress.
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 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
Details
- Congress
- 119th
- Chamber
- Senate
- Status
- summarized
- Action
- Reported to Senate
- Action Date
- 2026-07-16
- Date Added
- 2026-07-28
- Source
- Congress.gov →
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