HR8205-119

What This Bill Does

The Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 extends the underlying ALS Act authorities from 2026 to 2031 and expresses House Energy and Commerce Committee support for direct appropriations to carry out each section. It improves the grants program for ALS therapies by requiring the Health and Human Services Secretary, when reviewing renewal applications for grants tied to investigational drugs, to assess clinical-trial status using patient-enrollment data and to request interim clinical-trial data from the drug manufacturer. It defines phase 3 to include phase 2/3 combined trials and planned phase 3 trials not yet enrolling participants. The bill requires the FDA Commissioner within one year to publish an updated action plan for ALS and other rare neurodegenerative diseases covering five-year program enhancements, policy development, regulatory science initiatives, needed resources, and coordination with rare neurodegenerative disease communities that are not specifically ALS communities. The report must also describe FDA actions under the June 23, 2022 Action Plan, effects on therapy development and regulatory consideration, programs and initiatives created, and implementation for non-ALS rare neurodegenerative diseases. GAO must report to House Energy and Commerce and Senate HELP committees within four years using analyses and data described in the existing Act.

Who Benefits and How

People living with ALS benefit from continued therapy-development authorities through 2031 and more attention to clinical-trial enrollment. Patients with rare neurodegenerative diseases other than ALS benefit because FDA must address coordination with non-ALS communities and implementation beyond ALS. ALS therapy researchers benefit from reauthorized grant programs and clearer renewal-review expectations. Investigational drug manufacturers benefit from continued program support but must share interim data when requested. FDA rare-disease staff benefit from a five-year action plan and resource needs analysis. Congressional health committees benefit from FDA and GAO reports on implementation and therapy-development effects.

Who Bears the Burden and How

The HHS Secretary and grant reviewers must assess clinical-trial status and enrollment data during grant renewals. Investigational drug manufacturers must respond to requests for interim clinical-trial data. The FDA Commissioner must publish an updated action plan and account for 2022 Action Plan implementation, program enhancements, regulatory science initiatives, resources, and non-ALS community coordination. FDA rare neurodegenerative disease staff must support five-year planning and reporting. GAO analysts must prepare a four-year report to Congress. Federal budget managers may face pressure to provide direct appropriations through 2031.

Key Provisions

• Extends the Accelerating Access to Critical Therapies for ALS Act from 2026 to 2031.
• Provides committee support for direct appropriations to carry out each section of the ALS Act.
• Requires grant-renewal reviews to assess clinical-trial enrollment status for investigational drugs.
• Requires the Secretary to request interim clinical-trial data from investigational-drug manufacturers.
• Defines phase 3 to include combined phase 2/3 trials and planned phase 3 trials not yet enrolling.
• Requires FDA to publish an updated ALS and rare neurodegenerative disease action plan within one year.
• Requires GAO to report to House Energy and Commerce and Senate HELP committees within four years.