Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
- Bill Number
- H.R. 8205
- Origin Chamber
- House
- Congress
- 119th Congress, Session 2
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2026-07-09: Placed on the Union Calendar, Calendar No. 637.
- Last Updated
- 2026-07-10T10:23:20Z
AI-Generated Summary
Purpose This legislation reauthorizes and updates the Accelerating Access to Critical Therapies for ALS Act (Public Law 117-79) to extend support for research and regulatory efforts on treatments for amyotrophic lateral sclerosis (ALS) and other rare neurodegenerative diseases through fiscal year 2031.
Key Provisions
- Extends the overall authorization of the original Act and related grant programs from 2026 to 2031.
- Requires the Secretary of Health and Human Services to review renewal grant applications by examining enrollment data, safety information, and any available efficacy results for the investigational drug.
- Mandates that grant recipients promptly report new and serious unexpected adverse events to the grant-making institution, in addition to existing federal safety rules.
- Clarifies that "phase 3" clinical trials include combined phase 2/3 trials that begin enrollment within a timeframe set by the grant terms.
- Directs the Food and Drug Administration (FDA) Commissioner to publish a 5-year action plan within 18 months of enactment describing intended enhancements to programs, policies, and regulatory science for rare neurodegenerative diseases, followed by a progress report after 5 years.
Significant Changes to Existing Law
- Updates expiration dates in two sections of the original Act to extend funding and program authority by five years.
- Adds new review standards and safety reporting obligations for ALS research grants.
- Expands the definition of participating clinical trials to cover combined early- and late-stage studies.
- Introduces a formal FDA action plan and follow-up reporting requirement under the existing rare neurodegenerative disease section.
Potential Impacts
- Government agencies: Extends FDA and Department of Health and Human Services responsibilities for grant oversight and regulatory planning through 2031.
- Citizens: May increase availability of investigational therapies for ALS patients by supporting longer-term research and safety monitoring.
- International relations: No direct effects identified in the legislation.
Main Stakeholders Affected
- Individuals with ALS and other rare neurodegenerative diseases.
- Drug manufacturers and clinical trial sponsors.
- Researchers and medical institutions receiving grants.
- The FDA and other federal health agencies.
- Members of Congress involved in health policy.
Notable Legal, Constitutional, or Political Implications The bill makes no changes to constitutional authority or creates new legal obligations beyond extending and refining existing public health programs. It maintains a bipartisan approach to rare disease research without altering regulatory frameworks in ways that raise separation-of-powers concerns.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (103)
Rep. Calvert, Ken [R-CA-41], Rep. Fitzpatrick, Brian K. [R-PA-1], Rep. Schakowsky, Janice D. [D-IL-9], Rep. McCaul, Michael T. [R-TX-10], Rep. Auchincloss, Jake [D-MA-4], Rep. DesJarlais, Scott [R-TN-4], Rep. Craig, Angie [D-MN-2], Rep. Valadao, David G. [R-CA-22], Rep. Crow, Jason [D-CO-6], Rep. Thompson, Glenn [R-PA-15], Rep. Moore, Gwen [D-WI-4], Rep. Hurd, Jeff [R-CO-3], Rep. Schneider, Bradley Scott [D-IL-10], Rep. Joyce, David P. [R-OH-14], Rep. Veasey, Marc A. [D-TX-33], Rep. Salazar, Maria Elvira [R-FL-27], Rep. Bonamici, Suzanne [D-OR-1], Rep. Bilirakis, Gus M. [R-FL-12], Rep. Sherman, Brad [D-CA-32], Rep. Garbarino, Andrew R. [R-NY-2], Rep. Lynch, Stephen F. [D-MA-8], Rep. Bacon, Don [R-NE-2], Rep. Cohen, Steve [D-TN-9], Rep. Sessions, Pete [R-TX-17], Rep. Smith, Adam [D-WA-9], Rep. Obernolte, Jay [R-CA-23], Rep. Dean, Madeleine [D-PA-4], Rep. Cole, Tom [R-OK-4], Rep. Foushee, Valerie P. [D-NC-4], Rep. Rutherford, John H. [R-FL-5], Rep. Sewell, Terri A. [D-AL-7], Rep. Wilson, Joe [R-SC-2], Rep. Davis, Danny K. [D-IL-7], Rep. Aderholt, Robert B. [R-AL-4], Rep. Torres, Ritchie [D-NY-15], Rep. Mann, Tracey [R-KS-1], Del. Norton, Eleanor Holmes [D-DC-At Large], Rep. Van Drew, Jefferson [R-NJ-2], Rep. Krishnamoorthi, Raja [D-IL-8], Rep. Alford, Mark [R-MO-4], Rep. Underwood, Lauren [D-IL-14], Rep. LaLota, Nick [R-NY-1], Rep. Schrier, Kim [D-WA-8], Rep. Kim, Young [R-CA-40], Rep. Matsui, Doris O. [D-CA-7], Rep. Edwards, Chuck [R-NC-11], Rep. Dingell, Debbie [D-MI-6], Rep. Walberg, Tim [R-MI-5], Rep. Tlaib, Rashida [D-MI-12], Rep. Weber, Randy K. Sr. [R-TX-14] and 53 more
Recent Actions
- 2026-07-09: Placed on the Union Calendar, Calendar No. 637.
- 2026-07-09: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-733.
- 2026-07-09: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-733.
- 2026-05-21: Ordered to be Reported (Amended) by the Yeas and Nays: 46 - 0.
- 2026-05-21: Committee Consideration and Mark-up Session Held
- 2026-05-13: Forwarded by Subcommittee to Full Committee by Voice Vote.
- 2026-05-13: Subcommittee Consideration and Mark-up Session Held
- 2026-04-06: Referred to the Subcommittee on Health.
- 2026-04-06: Referred to the House Committee on Energy and Commerce.
- 2026-04-06: Introduced in House
- 2026-04-06: Introduced in House
Bill Versions
- Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 — issued 2026-04-06 — PDF (6 pages)
- Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 — issued 2026-07-09 — PDF (8 pages)