ACCELERATING ACCESS TO CRITICAL THERAPIES FOR ALS REAUTHORIZATION ACT OF 2026

On 2026-07-20, Representative Mike Quigley (D-IL-5) delivered a floor speech titled "ACCELERATING ACCESS TO CRITICAL THERAPIES FOR ALS REAUTHORIZATION ACT OF 2026" in the House.

ACCELERATING ACCESS TO CRITICAL THERAPIES FOR ALS REAUTHORIZATION ACT OF 2026

Congressional Record, Volume 172 Issue 118 (Monday, July 20, 2026) [Congressional Record Volume 172, Number 118 (Monday, July 20, 2026)] [House] [Pages H4652-H4654] From the Congressional Record Online through the Government Publishing Office [ www.gpo.gov ] ACCELERATING ACCESS TO CRITICAL THERAPIES FOR ALS REAUTHORIZATION ACT OF 2026 Mr. GUTHRIE. Mr. Speaker, I move to suspend the rules and pass the bill [[Page H4653]] (H.R. 8205) 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, as amended. The Clerk read the title of the bill. The text of the bill is as follows: H.R. 8205 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) Renewal of Grants for Research on Therapies for ALS 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) Renewal of grants for research on therapies for als review.--In reviewing applications for renewals of a grant awarded under this section with respect to an investigational drug, the Secretary shall request from the manufacturer or sponsor, and assess, the enrollment, safety, and any available efficacy data relating to the investigational drug in the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis.''. (b) Reporting Safety Data.--Section 2(c) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended-- (1) in paragraph (2)(B), by striking ``and'' at the end; (2) in paragraph (3), by striking the period at the end and inserting ``; and''; and (3) by adding at the end the following: ``(4) the entity seeking such grant will promptly report any new and serious adverse events and safety information that is considered to be unexpected with respect to the phase 3 trial to the grant-making institution, in addition to complying with the safety reporting requirements under section 312.32 of title 21, Code of Federal Regulations (or any successor regulations).''. (c) 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 that begins enrollment within a timeframe, determined by the Secretary through the terms and conditions of the grant awarded under this section.''. SEC. 4. FDA RARE NEURODEGENERATIVE DISEASE ACTION PLAN. Section 4 of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360aa note) is amended-- (1) in the section heading, by striking ``als and other rare neurodegenerative disease action plan'' and inserting ``fda rare neurodegenerative disease action plan''; and (2) by adding at the end the following: ``(c) FDA Rare Neurodegenerative Disease Action Plan.-- ``(1) In general.--Not later than 18 months 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 an action plan that includes a description of the actions that the Food and Drug Administration intends to take during the 5-year period following publication of the action plan with respect to the program enhancements, policy development, regulatory science initiatives, and other appropriate initiatives described in subsection (a). ``(2) Report.--Not later than 5 years 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 describes the actions taken by the Food and Drug Administration under the action plan published under paragraph (1) and the extent to which such action plan meets the requirements specified in paragraph (1).''. The SPEAKER pro tempore. Pursuant to the rule, the gentleman from Kentucky (Mr. Guthrie) and the gentlewoman from Colorado (Ms. DeGette) each will control 20 minutes. The Chair recognizes the gentleman from Kentucky. General Leave Mr. GUTHRIE. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days to revise and extend their remarks on the legislation and to include extraneous material on H.R. 8205. The SPEAKER pro tempore. Is there objection to the request of the gentleman from Kentucky? There was no objection. Mr. GUTHRIE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise today in strong support of H.R. 8205 led by my colleagues, Representative Quigley and Representative Calvert. H.R. 8205 reauthorizes the Accelerating Access to Critical Therapies for ALS Reauthorization Act, which has supported critical research and development for ALS therapies. The ACT for ALS program has worked to expand access to key therapies for both individuals with ALS and those with other rare neurodegenerative conditions. It is imperative that we pass this bill today to continue advancing research and therapeutic development in the fight against this disease. To my fellow Americans living with ALS and their caregivers, Mr. Speaker, I want to take a moment to let them know that I recognize their resilience and their commitment to a better future for themselves and other patients with ALS. Mr. Speaker, I want them to know that I stand with them, and I ask that my colleagues do the same. Mr. Speaker, I encourage my colleagues to support this bill, and I reserve the balance of my time. Ms. DeGETTE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, about 5,000 Americans are diagnosed with ALS every year. It is a disease that causes the nervous system to stop working and die, leading to muscle weakness and eventually paralysis. Essentially, when someone gets the diagnosis, it is a death sentence. I am all too familiar with this disease and its rapid progression because in 1996, I lost my father-in-law to ALS. The original Accelerating Access to Critical Therapies for ALS Act passed in 2021 and unleashed incredible Federal resources to improve our understanding of this relentless disease in search of a cure. It revolutionized the way FDA uses real-world evidence to foster the development of ALS therapeutics and gave patients a chance to try investigational drugs for rare neurodegenerative diseases. We have the opportunity today to ensure ALS patients can continue to access promising new therapies, and our preeminent biomedical research institutions can continue to work towards a cure. This reauthorization will provide the continuing statutory basis for the great work that the Accelerating Access to Critical Therapies for ALS Act began, and it couldn't come at a better moment. We have seen immense research progress in the 5 years since passage. Health Subcommittee members here today heard from Brian Wallach and Sandra Abrevaya in our hearing on this bill a few months ago when they told us with no uncertainty how important it is for people facing down this cruel disease that we keep this momentum going. Brian and Sandra are an inspiration to all of us and to people everywhere who are seeking cures for these terrible diseases. I want to tell Congressman Mike Quigley that his unwavering leadership on the original Accelerating Access to Critical Therapies for ALS Act and this reauthorization is saving and improving lives. I thank them for putting us on the path of finding a cure for ALS. Mr. Speaker, I yield 3 minutes to the gentleman from Illinois (Mr. Quigley), who is the sponsor of this bill. Mr. QUIGLEY. Mr. Speaker, I thank the gentlewoman from Colorado for her kind remarks. Mr. Speaker, several years ago, a Chicagoan named Brian Wallach came to my office and shared the fact that he was just diagnosed with ALS, a devastating disease that steals a person's ability to move or speak. The average life expectancy at the time with someone diagnosed with ALS was 2 to 5 years. When Brian came to visit us in Congress, that was the reality he was facing. He cofounded an organization called I AM ALS with his wife, Sandra Abrevaya. Sandra's life changed overnight, too when she became an ALS caretaker. Since then, she cofounded a company to improve the care of people living with ALS. This awe-inspiring couple came to my office with a big idea to advance ALS research and access to treatments. After meeting with Brian and Sandra, I was convinced that ALS was not incurable. The research was just underfunded. I was moved by their dedication to each other and the cause. [[Page H4654]] Like too many families across the country, my family has been touched by neurodegenerative disease. I lost my father to Parkinson's. However, since I started working on the first Accelerating Access to Critical Therapies for ALS Act, there hasn't been one Member of Congress whom I talked to who didn't have a personal story or know the impact of one of these diseases. Our bipartisan work on the first Accelerating Access to Critical Therapies for ALS Act broke through the bitter politics that can divide this place. I believe we have the opportunity 

Referenced legislation: HR8205, HR8205