Sponsors (104)
The bill seeks to speed and better-account for development of ALS and rare neurodegenerative therapies through expanded funding, safety reporting, and an FDA action plan, while trading off higher federal costs, new burdens on researchers, and some uncertainty or potential delays for certain trials.
People with ALS and other rare neurodegenerative diseases could get faster development and earlier access to therapies because the bill expands grant/contract support, treats certain phase 2/3 trials as phase 3 for eligibility, and promotes coordinated FDA priorities.
Patients and trial participants would benefit from stronger safety oversight and quicker detection of serious harms because the bill requires HHS review of enrollment/safety/efficacy at renewal and prompt adverse-event reporting to grant-makers in addition to FDA reporting.
Researchers, industry, and the public gain greater transparency and regulatory predictability because the FDA must publish an action plan and a 5-year progress report, improving accountability and planning for sponsors and investors.
People with ALS could see slower progress if stricter renewal data reviews lead to delayed or reduced grant renewals for investigational drugs, potentially slowing development timelines.
Taxpayers may face higher federal costs because expanded grant or planning requirements increase spending and impose administrative costs on FDA without specified offsets.
Researchers, hospitals, and sponsors will incur additional administrative and reporting burdens (extra data requests, prompt adverse-event reporting), which could slow trials, applications, and grant workflows.
Based on analysis of 4 sections of legislative text.
Modifies ALS grant law to add safety and data reporting rules, clarify phase 2/3 trial timing, and require an FDA five-year action plan and later report for rare neurodegenerative diseases.
Official title: Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
Introduced April 6, 2026 by Mike Quigley · Last progress July 23, 2026
Updates federal grant rules for investigational ALS therapies by adding reporting and review requirements for sponsors, applicants, and the Secretary when renewing grants, and clarifies that certain combined phase 2/3 trials qualify as phase 3 for the program. Requires the FDA Commissioner to publish a publicly posted five-year "rare neurodegenerative disease action plan" within 18 months and a follow-up report within five years describing actions taken and progress made. The bill modifies existing grant authority under 21 U.S.C. §360ee to require manufacturers/sponsors to provide enrollment, safety, and any available efficacy data on renewal; requires prompt reporting of new, serious, unexpected adverse events to grant-making institutions in addition to FDA reporting; and defines timing rules for phase 2/3 trials. It also directs new public-facing FDA planning and reporting for rare neurodegenerative diseases to guide program enhancements and regulatory science initiatives.