HR8205Referred to Committee

Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

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Introduced
In Committee
3
Passed One Chamber
4
Passed Both
5
Signed into Law
119th
Congress
2026-04-06
Introduced
103
Cosponsors
HR
ⓘ
Type

Sponsor

Mike Quigley
Mike Quigley
Democrat · IL · Representative
Votes with party: 97.8% (580 recorded votes)

Full profile: /officials/Q000023

Source: Congress.gov · FEC

Cosponsors (103)

Members who have signed on to support this bill since introduction. Source: Congress.gov.

Latest Action

The most recent step in the bill's legislative path. Committee Activity below shows referrals and reports; the full action-by-action history including floor proceedings lives at Congress.gov →

Placed on the Union Calendar, Calendar No. 637.

2026-07-09

Source: Congress.gov

Committee Activity

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Plain-English Summary

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 NIH, in considering renewal of its grants, must assess available information on the safety and efficacy of the investigational drugs. It must also require grantees to promptly report serious and unexpected adverse events associated with their investigational drugs. Additionally, 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, that treat ALS and other rare neurodegenerative diseases. The FDA must also publish a report describing the actions it has taken under the plan.

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

Subjects

Health

Full Bill Text

Verbatim text published on Congress.gov via GovInfo. Use Cmd+F / Ctrl+F to search within this excerpt.

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [H.R. 8205 Introduced in House (IH)] <DOC> 119th CONGRESS 2d Session 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. _______________________________________________________________________ IN THE HOUSE OF REPRESENTATIVES April 6, 2026 Mr. Quigley (for himself and Mr. Calvert) introduced the following bill; which was referred to the Committee on Energy and Commerce _______________________________________________________________________ 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''. (c) Sense of Congress.--The Committee on Energy and Commerce of the House of Representatives expresses support for directly appropriating funds to carry out each section of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117-79). 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…
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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. Not later than 4 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report containing the analyses and data described in section 6 of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117- 79) (as in effect on the date of enactment of this Act). <all>
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