Extends the ALS therapy research grant program through fiscal year 2031, requires closer review of renewal applications, and adds safety reporting duties for grant recipients.

• Replaces the 2026 end dates in the Accelerating Access to Critical Therapies for ALS Act with 2031, extending its grant authority through fiscal year 2031.
• Requires the FDA to request and assess enrollment, safety, and any available efficacy data from manufacturers or sponsors when reviewing grant renewals for investigational drugs.
• Requires grant recipients to promptly report new serious adverse events and unexpected safety information from phase 3 trials to the grant-making institution.
• Counts a phase 2/3 combined trial as phase 3 if it begins enrollment within a timeframe the Secretary sets in the grant terms, and requires the FDA to publish an action plan within 18 months and a progress report within 5 years.

• Energy and Commerce Committee (House)
• Health Subcommittee

Health