ALS Therapies Reauthorization Act 2026

Full Title:
Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

Summary#

This bill reauthorizes the Accelerating Access to Critical Therapies for ALS Act through fiscal year 2031 by changing date references in the original law. It adds new rules for the program that gives grants for ALS research. When reviewing renewals of research grants, the Food and Drug Administration (FDA) must assess clinical trial enrollment and may request that a drug manufacturer share interim clinical trial data. The bill clarifies that a "phase 3" trial can include a combined phase 2/3 trial and planned phase 3 trials that are not yet enrolling. The FDA must publish an updated action plan within one year that describes planned actions for five years, the resources needed, and how the agency will coordinate with rare neurodegenerative disease communities beyond ALS. The bill also asks for a Government Accountability Office (GAO) report to Congress within four years with the analyses described in the original Act. The Committee on Energy and Commerce expresses support for directly appropriating funds to carry out the Act's sections.

What it means for you#

  • Researchers and institutions that receive grants for ALS therapies may be asked to show clinical trial enrollment progress for grant renewals.
  • Drug manufacturers working on investigational ALS treatments may be requested to share interim clinical trial data with the FDA for grant review purposes.
  • The FDA will publish an updated 5-year action plan about ALS and other rare neurodegenerative diseases, including needed resources and coordination steps.
  • Advocacy groups for rare neurodegenerative diseases beyond ALS can expect the FDA plan to describe how the agency will work with those communities.
  • Congress will receive a GAO report with analyses related to the original Act within four years.

Expenses#

No publicly available information on total costs or specific appropriations is included in the bill text. The bill contains a "sense of Congress" expressing support for directly appropriating funds to carry out the Act, but it does not list dollar amounts or formal funding authorizations.

Proponents' View#

The bill text reauthorizes the program through 2031 and adds measures intended to improve grant review, clarify trial definitions, require an updated FDA action plan, and request a GAO report. The Committee on Energy and Commerce expresses support for direct appropriation of funds to carry out the Act. The bill was introduced by the listed sponsors.

Opponents' View#

No publicly available information in the bill text about opposition, objections, or views opposing the measure.