Technical corrections only. The diff between v2 (Reported in Senate) and v3 (Engrossed in Senate) primarily reflects the bill's progression through the legislative process, changing from 'A BILL' to 'AN ACT' and adding an attestation of passage in the Senate. The substantive legislative text of the bill remains identical between both versions.
Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
- Sponsor
- Sen. Murkowski, Lisa [R-AK]
- Committees
- Health, Education, Labor, and Pensions Committee (primary)
- Last action
- Aug 10, 2026
Bottom line
The bill extends and enhances federal programs aimed at accelerating research and access to therapies for ALS and other rare neurodegenerative diseases.
What it actually does
This bill reauthorizes the Accelerating Access to Critical Therapies for ALS Act through fiscal year 2031, extending federal support for research and expanded access grants for amyotrophic lateral sclerosis (ALS). It also introduces several improvements to the grant program, including enhanced data reporting requirements and clearer definitions for clinical trials. Furthermore, it mandates regular updates to the FDA's action plans for rare neurodegenerative diseases and requires new reports from the Department of Health and Human Services (HHS) on program effectiveness.
Proponents argue
Supporters argue that reauthorizing this critical act ensures continued momentum in the fight against ALS, a devastating neurodegenerative disease with limited treatment options. They contend that the proposed improvements to grant applications, data reporting, and FDA action plans will make the programs more efficient, transparent, and effective, ultimately benefiting patients by accelerating the development and availability of new therapies. The inclusion of rare neurodegenerative diseases in the FDA action plan updates is also seen as a positive step towards broader impact.
Opponents contend
No organized opposition is typically raised against reauthorization bills for medical research, especially for rare diseases like ALS. Potential critics might raise concerns about the overall cost of reauthorizing federal programs without new, dedicated funding mechanisms, or question the administrative burden of new reporting requirements on researchers and agencies. However, these are generally minor concerns compared to the broad support for addressing such a severe disease.
The bill is short and relatively easy to read, allowing an informed reader to understand its provisions within the given time.
Section 2
Reauthorization of Accelerating Access to Critical Therapies for ALS Act
This section extends the authorization for the Accelerating Access to Critical Therapies for ALS Act, including its provisions for grants for ALS research, from fiscal years 2022 through 2026 to fiscal years 2027 through 2031. This ensures that the programs established by the original act, which aim to facilitate access to investigational drugs for ALS patients and support research, can continue to operate for an additional five years.
Supporters argue
Supporters argue that reauthorization is essential to maintain the momentum in ALS research and ensure that patients continue to have access to potentially life-saving investigational treatments. They emphasize the importance of sustained federal commitment to combat this devastating disease.
Critics contend
No specific opposition is typically raised against the reauthorization of medical research programs for severe diseases like ALS, given the broad public health benefits.
Tradeoffs
The primary tension is the ongoing commitment of federal resources versus other budgetary priorities, though the reauthorization of an existing program often faces less scrutiny than new spending initiatives.
Section 3
Improvements to Program for Grants for Research on Therapies for ALS
This section amends the existing grant program for ALS research to enhance its effectiveness. Key changes include requiring grant applicants to describe how data generated will support ALS research, ensuring prompt reporting of safety data from ongoing clinical trials, and mandating that the Secretary of Health and Human Services assess enrollment, safety, and efficacy data when renewing grants. It also broadens the definition of 'phase 3 clinical trial' to include phase 2/3 combined trials and planned phase 3 trials not yet enrolling participants, potentially expanding eligibility for grants.
Section 4
Updates to FDA Action Plans for Rare Neurodegenerative Diseases
This section amends the requirements for the Food and Drug Administration's (FDA) action plans related to ALS and other rare neurodegenerative diseases. It renames the section to focus on 'FDA' action plans and mandates that the FDA develop or update these plans every five years, starting one year after the bill's enactment. New requirements for the action plans include describing previous actions taken, planned future actions, any barriers to implementation, and estimated resources needed to address those barriers. This aims to make the FDA's strategic planning more transparent and actionable.
Section 5
New Reporting Requirements for GAO and HHS
This section expands the reporting requirements related to the Accelerating Access to Critical Therapies for ALS Act. It updates the timing for an existing Government Accountability Office (GAO) report and, more significantly, adds a new mandate for the Secretary of Health and Human Services (HHS) to submit a report to Congress. This HHS report, due four years after the bill's enactment, must assess the effectiveness of activities carried out under sections 2, 3, and 5 of the original Act (related to reauthorization, grant improvements, and other provisions) and provide recommendations for improvement. This ensures ongoing oversight and evaluation of the programs.
This provision clarifies the definition of 'phase 3 clinical trial' to include a phase 2/3 combined trial and a planned phase 3 clinical trial that is not yet enrolling participants.
Section 3(5)(B)
Why it matters:This is standard legislative practice for defining terms within a specific program. It's a technical clarification rather than an evasive maneuver.
Case for: Supporters would argue that this clarification is beneficial because it broadens the scope of trials that can be considered for grants, allowing for earlier support of promising research and more flexible trial designs (like combined phases). This could accelerate drug development by providing funding at critical stages.
Case against: No specific opposition is likely, as it's a technical clarification. However, some might argue that expanding the definition could dilute resources if too many early-stage or planned trials become eligible, potentially diverting funds from trials that are already in advanced stages of enrollment.
Estimated impact: This clarification could increase the number of eligible clinical trials for expanded access grants, potentially shifting the distribution of grant funding to earlier-stage or combined-phase trials.