HB 4610: Safeguard the Right-To-Try Cutting-Edge Medicine Act - West Virginia

hb4610 s hhr am _ 3-1 adopted.htm → Enrolled Committee Substitute · 4 edits · Apr 1, 2026

MODERATE

The bill was finalized into an enrolled version, changing its status from a committee amendment to an official law. The core policy text remains the same, establishing a 'Right-to-Try' framework that allows patients with life-threatening illnesses to access investigational drugs and devices not yet approved by the FDA. A key substantive change is the repeal of the previous legislative findings section, while the detailed eligibility criteria and consent requirements for patients remain intact.

Scope change

The bill's scope is now formally enacted as law, effective 90 days after passage, rather than remaining in a committee amendment state.

TECHNICAL

The section containing legislative findings was removed, as it was superseded by the final act text.

TIMELINE

The bill was formally enacted with a specific effective date of 90 days from passage (June 12, 2026).

DEFINITION

The final text codifies specific definitions for 'eligible patient' and 'investigational drug, biological product or device' to ensure clarity in application.

REQUIREMENT

Detailed requirements for written informed consent were added, including specific disclosures about insurance coverage, hospice eligibility, and patient liability for costs.

Engrossed Committee Substitute → hb4610 s hhr am _ 3-1 adopted.htm · 3 edits

MINOR

The bill text was replaced with a committee amendment record rather than the full legislative act, effectively removing the substantive Right-to-Try law. The amendment specifically changes the legal citation for hospital exclusions from the general health code to a specific section within the mental health code, narrowing the definition of who is ineligible for the treatment program.

Scope change

The bill's scope was narrowed by changing the exclusion criteria for inpatients from a general hospital license to a specific mental health facility designation.

ELIGIBILITY

Removed the entire text of the Right-to-Try Act, including definitions for eligible patients, investigational drugs, and consent requirements.

Changed the exclusion for inpatients from 'hospital licensed or certified pursuant to §16-5B- et seq.' to '§16B-5B-1 et seq.', restricting the exclusion to specific mental health facilities rather than all hospitals.

SCOPE

Removed the legislative findings and the full bill text that would have amended the West Virginia Code.

Committee Substitute → Engrossed Committee Substitute · 1 edit · Mar 14, 2026

MINOR

The bill's status page was updated to reflect the 'Engrossed' version as the current text, replacing the 'Committee Substitute' label. The substantive text of the bill itself remains unchanged, with no modifications to the legal requirements, definitions, or eligibility criteria.

TECHNICAL

The legislative history and version labels on the webpage were updated to show the 'Engrossed Version' as the active text and removed the 'Committee Substitute' label.

Introduced Version → Committee Substitute · 6 edits

MODERATE

The bill was significantly rewritten to change its legal effect from creating a new right to try to amending existing laws. The new version removes protections for patients' heirs from debt and eliminates the ban on private lawsuits against manufacturers. It also tightens eligibility requirements by excluding hospitalized inpatients and adding specific criteria about clinical trial access.

Scope change

The bill's scope shifted from establishing a completely new article (Article 51A) to amending and repealing existing sections within Article 51. The new version repeals the previous debt protection for heirs and the prohibition on private lawsuits.

ELIGIBILITY

Removed the provision stating that a patient's heirs are not liable for outstanding debt related to the treatment if the patient dies.

Added a new exclusion stating that patients being treated as inpatients in a hospital are no longer eligible for the program.

Added specific criteria requiring the patient to have been unable to participate in a nearby clinical trial or not accepted into one within one week.

ENFORCEMENT

Removed the ban on private lawsuits (private right of action) against drug manufacturers for harm caused by the investigational treatments.

DEFINITION

Changed the definition of 'investigational drug' to include products that have successfully completed Phase 1 of a clinical trial, broadening the scope beyond just unique genetic products.

TIMELINE

Removed the specific effective date of January 1, 2027, which was included in the original introduced version.

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

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