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HB 4610

Safeguard the Right-To-Try Cutting-Edge Medicine Act

2026 Regular Session Introduced by Mike Hornby

West Virginia's Right-to-Try law lets eligible terminal patients access investigational therapies outside FDA approval with physician oversight and informed consent, though costs m

Chapter 183, Acts, Regular Session, 2026
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Bill Summary · HB 4610

Overview

West Virginia House Bill 4610 (2026) creates a state Right-to-Try framework to permit certain terminal or life-threatening patients to access investigational drugs, biological products, or devices outside of FDA-approved use. The bill defines eligibility, the scope of what counts as an investigational treatment, and the informed-consent requirements, while clarifying procedural aspects and patient financial responsibilities.

Main purpose and intent

  • Establish a Right-to-Try regime for patients with terminal or life-threatening illnesses who have exhausted approved treatment options and cannot access a clinical trial within a reasonable distance.
  • Allow eligible patients to pursue investigational products not yet FDA-approved, including individualized therapies produced for a specific patient.
  • Ensure informed consent and physician oversight are in place, while delineating responsibilities around costs and hospice eligibility.

Key provisions and changes

  • Definitions (Section §16-51-3):
    • Eligible patient:
    • Has a terminal illness or life-threatening/severely debilitating illness, as attested by a treating physician.
    • Has explored currently FDA-approved treatment options.
    • Has been unable to participate in a clinical trial within 100 miles of home or not accepted within one week of trial-application completion.
    • Receives a physician recommendation for an investigational drug, biological product, or device.
    • Provides written informed consent (or consent by parent/guardian if the patient is a minor or lacks capacity) and physician documentation confirming eligibility.
    • Does not include individuals being treated as inpatients in licensed hospitals (as defined by specific WV code references).
    • Investigational drug/biological product/device:
    • A product that has completed Phase I in a clinical trial but not FDA-approved for general use, or a product uniquely produced for an individual patient based on their genetic profile (including individualized gene therapy antisense oligonucleotides and individualized neoantigen vaccines).
    • Terminal illness and life-threatening/debilitating illness definitions align with applicable FDA regulatory definitions.
    • Written, informed consent:
    • Must include disclosure of approved treatments, recognition that conventional options are unlikely to prolong life, identification of the specific investigational product, and realistic outcomes (including potential for worse outcomes and death, given treatment risks).
    • Must clarify that insurance coverage and related care may not be provided for investigational treatments.
    • Must address hospice eligibility implications, home health care denial possibilities, and potential liability for treatment costs.
  • Inpatient exclusion:
    • The framework applies to eligible patients not currently hospitalized in facilities regulated under the referenced WV hospital codes.
  • Procedural and coordination aspects:
    • The bill places responsibility on treating physicians to assess eligibility, secure consent, and document meeting criteria.
    • The act defines the rights and responsibilities of patients and providers in the context of accessing investigational therapies outside standard FDA approval pathways.
  • Repeal and reenactment:
    • Repeals a prior §16-51-2 and reenacts §16-51-3 within the Right-to-Try Act structure, aligning with the act’s definitions and patient-physician responsibilities.

Who/what is affected

  • Patients with terminal or life-threatening illnesses who have exhausted approved options and cannot access trials within 100 miles.
  • Treating physicians who determine eligibility, obtain consent, and document compliance with the act.
  • Providers and insurers:
    • The written consent documents explicitly note that health insurers may not cover investigational therapies or related care.
  • Hospices:
    • The written consent form addresses potential changes to hospice eligibility if curative treatment is pursued and may be withdrawn, with reinstatement if curative treatment ends.
  • Hospitals:
    • Hospitals and inpatient settings not covered under the act’s inpatient exclusion remain subject to general standards; the act excludes inpatients from eligibility for this Right-to-Try pathway.

Procedural and timeline aspects

  • Legislative history indicates passage through multiple committees and readings in 2026.
  • The bill was enacted (Chapter 183) and became law in 2026, with governor assent achieved in spring 2026.
  • Key milestones reflect orderly progression through House and Senate, including amendments and final enactment before signing.

Potential impact

  • Provides a formal right for eligible WV patients to access investigational therapies outside FDA approval, subject to physician recommendation and patient consent.
  • Creates explicit risk disclosure and cost liability expectations for patients and estates.
  • Aims to balance patient access with physician oversight and financial risk, while acknowledging limits of current insurance coverage and hospice status when pursuing investigational options.
  • May influence how clinicians discuss treatment options, consent processes, and documentation when considering non-FDA-approved therapies.

Compiled from official sources — confirm details with the bill’s official record.

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