H.R. 8205 explained  ·  119th Congress  ·  Pending in Congress

Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

Create a free account or sign in to follow H.R. 8205 and get alerts. Policy area: Health Create a free account or sign in to follow the Health policy area and get alerts. ▲ 5 days since action Sponsor: Mike Quigley, IL-05, D → Congress.gov

Cosponsors: 103 (64 D, 39 R) · per Congress.gov, 2026-10-14

Introduced: 2026-04-06

Latest action (2026-10-14): Message on Senate action sent to the House.

What H.R. 8205 does, in plain terms

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.

Official summary by the Congressional Research Service, via Congress.gov.

Constitution Index

“VFA Constitution grade”

A

Constitutionally sound

Graded 2026-10-11

SI-generated grade · five published checks · not individually reviewed by a person · methodology

The bill reauthorizes and revises federal programs supporting research and development for ALS and other neurodegenerative diseases. It operates within Congress's enumerated powers under the Spending Clause and the Patent Clause, does not infringe on any constitutional rights, respects individual sovereignty by not restricting personal freedoms, and appropriately delegates implementation to federal agencies without consolidating decision-making beyond the necessary federal role in medical research and drug regulation. The bill also includes provisions for safety monitoring and transparency, aligning with due process principles.

  • ✓ Passes · Enumerated powers
    Congress has authority under Article I, Section 8, Clause 1 (Spending Clause) to provide for the general welfare by funding medical research, and under Article I, Section 8, Clause 8 (Patent Clause) to promote the progress of science and useful arts. The bill authorizes NIH and FDA grants and partnerships, which are exercises of the spending power. It does not exceed enumerated powers.
  • ✓ Passes · Bill of Rights
    The bill does not restrict speech, religion, assembly, press, petition, the right to bear arms, or any other right protected by the Bill of Rights. It imposes no searches or seizures, no self-incrimination, no deprivation of life, liberty, or property without due process, and no cruel or unusual punishment. It is purely a funding and regulatory measure for medical research.
  • ✓ Passes · Individual sovereignty
    The bill does not restrict what individuals can do with their person, property, speech, labor, or belief. It facilitates access to investigational drugs and supports research, which expands individual options rather than restricting them. No compelling justification is needed because no restriction is imposed.
  • ✓ Passes · Decentralization
    The bill addresses a rare and complex disease that requires national coordination of research and regulatory oversight. An individual, family, or local community cannot handle the scale of NIH and FDA programs. States could not effectively regulate interstate drug development or ensure uniform access to investigational therapies. The federal role is appropriate and does not consolidate decision-ma…
  • ✓ Passes · Due process and takings
    The bill does not take property without just compensation. It imposes no penalties or deprivations. It includes procedural safeguards by requiring NIH to assess safety and efficacy data and to require grantees to report adverse events, and FDA to publish plans and reports, ensuring transparency and accountability. These provisions support fair and non-arbitrary government action.

Sources: Congress.gov: HR 8205 summary

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What should pass

“VFA SI Solution”

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ALS Research Reauthorization with Transparent Safety Review

Generated by VFA SI Solutions

Extend the federal ALS research and expanded-access research programs authorized by Public Law 117-79 through fiscal year 2031, strengthen review and safety reporting for research grants, and require an updated FDA plan and report for rare neurodegenerative diseases. The legislation supports research involving investigational drugs; it does not guarantee a patient access to a drug.

Bipartisan rationale: The proposal retains the existing ALS research and patient-access research pathways, adds review of safety and available efficacy data, and makes program outcomes clearer to patients and Congress. It keeps the current $100 million annual authorization instead of raising it, requires separate annual appropriations, and adds no state mandate or new patient entitlement. Those choices address patient and research priorities alongside cost control and oversight concerns without predicting support from any particular member.

Funding: Annual discretionary appropriations for HH $100 million authorized to be Oversight: HHS, including NIH and FDA wit Enforcement: HHS grant terms and existing FDA inv

Possible legislative path: Members in both chambers who favor ALS research and patient access may support the extension and safety review, while members focused on spending and administrative burden may scrutinize the continued authorization and added annual report. No vote count or whip estimate is asserted.

Source limits: The annual deidentified program report and plain-language patient guide are VFA additions, not existing law or provisions of H.R. 8205. The $100 million figure is an authorization, not an appropriation or cost estimate; verify the final enrolled or enacted H.R. 8205 text and current appropriations before publication. Expanded access remains subject to existing FDA and grant eligibility rules and does not guarantee treatment to any patient.

→ Article I, Section 8, Clause 1 (Spending and General Welfare Clause) → Article I, Section 8, Clause 18 (Necessary and Proper Clause) → Article I, Section 9, Clause 7 (Appropriations Clause)

Article I, Section 8, Clause 1 Article I, Section 8, Clause 18 Article I, Section 9, Clause 7

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