Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

Lisa Murkowski

Republican · AK · Senator

Source: Congress.gov · FEC

• Christopher A. Coons (D-DE)Original· 2026-04-30
• Alex Padilla (D-CA)· 2026-06-15
• Amy Klobuchar (D-MN)· 2026-06-15
• Shelley Moore Capito (R-WV)· 2026-06-15
• Susan M. Collins (R-ME)· 2026-06-15
• Jim Banks (R-IN)· 2026-06-16
• John R. Curtis (R-UT)· 2026-06-16
• Kirsten E. Gillibrand (D-NY)· 2026-06-16
• Margaret Wood Hassan (D-NH)· 2026-06-16
• Edward J. Markey (D-MA)· 2026-06-24
• Steve Daines (R-MT)· 2026-06-24
• David McCormick (R-PA)· 2026-07-21
• Jeff Merkley (D-OR)· 2026-07-21
• John Barrasso (R-WY)· 2026-07-23
• Sheldon Whitehouse (D-RI)· 2026-07-23

Passed Senate with an amendment by Voice Vote.

2026-08-04

Source: Congress.gov

Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 This 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 reauthorizes grants 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, and a 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.

Plain-English rewrite of the Congressional Research Service summary published on Congress.gov. Cached and reviewed.

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [S. 4472 Introduced in Senate (IS)] <DOC> 119th CONGRESS 2d Session S. 4472 To amend the Accelerating Access to Critical Therapies for ALS Act to reauthorize the provisions of such Act through fiscal year 2031, and for other purposes. _______________________________________________________________________ IN THE SENATE OF THE UNITED STATES April 30, 2026 Ms. Murkowski (for herself and Mr. Coons) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions _______________________________________________________________________ A BILL To amend the Accelerating Access to Critical Therapies for ALS Act to reauthorize the provisions of such Act through fiscal year 2031, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026''. SEC. 2. REAUTHORIZATION OF ACCELERATING ACCESS TO CRITICAL THERAPIES FOR ALS ACT. (a) In General.--Section 7 of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117-79) is amended by striking ``2026'' and inserting ``2031''. (b) Grants for ALS Research.--Section 2(f) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by striking ``2026'' and inserting ``2031''. SEC. 3. IMPROVEMENTS TO PROGRAM FOR GRANTS FOR RESEARCH ON THERAPIES FOR ALS. (a) Clinical Trial Status Review.--Section 2(b) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by adding at the end the following: ``(4) Clinical trial status review.-- ``(A) In general.--In reviewing applications for renewals of a grant awarded under this section with respect to an investigational drug, the Secretary shall assess the status of a clinical trial carried out for such drug with respect to data on enrollment of patients in such clinical trial. ``(B) Interim clinical trial data.--To enable the Secretary to make the assessment under subparagraph (A) with respect to an investigational drug, the Secretary shall request that the manufacturer of the investigational drug share interim clinical trial data with respect to such drug with the Secretary.''. (b) Clarifying Participating Clinical Trial Definition.--Section 2(e) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by adding at the end the following: ``(4) The term `phase 3', with respect to a clinical trial, includes a phase 2/3 combined trial and a planned phase 3 clinical trial that is not yet enrolling participants.''. SEC. 4. REPORT ON ALS AND OTHER RARE NEURODEGENERATIVE DISEASE ACTION PLANS. Section 4 of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360aa note) is amended by adding at the end the following: ``(c) Report on ALS and Other Rare Neurodegenerative Disease Action Plans.--Not later than one year after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, the Commissioner of Food and Drugs shall publish on the website of the Food and Drug Administration a report that contains-- ``(1) an updated action plan, including-- ``(A) a description of the actions the Food and Drug Administration intends to take during the 5-year period following publication of the plan with respect to the program enhancements, policy development, regulatory science initiatives, and other appropriate initiatives described in subsection (a); ``(B) a description of the resources necessary to implement each section of the plan within such 5-year period; and ``(C) specific approaches the Commissioner will take to improve coordination of implementation of the plan with rare neurodegenerative disease communities that are…

not specifically ALS communities; and ``(2) with respect to the Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) published by the Food and Drug Administration on June 23, 2022 (referred to in this section as the `2022 Action Plan'), a description of-- ``(A) the actions taken by the Food and Drug Administration under the 2022 Action Plan; ``(B) the effect of the implementation of the 2022 Action Plan on the development of therapies and regulatory consideration of therapies for ALS and other rare neurodegenerative diseases; ``(C) any programs and initiatives that established or carried out as part of the implementation of the 2022 Action Plan; and ``(D) the extent to which the 2022 Action Plan was implemented with respect to rare neurodegenerative diseases that are not amyotrophic lateral sclerosis.''. SEC. 5. GAO REPORT. Section 6 of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117-79) is amended, in the matter preceding paragraph (1)-- (1) by striking ``4 years after the date of the enactment of this Act'' and inserting ``5 years after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026''; and (2) by inserting ``, with respect to the 10-year period starting on the date of enactment of this Act'' after ``containing''. <all>

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