Safeguard the Right-To-Try Cutting-Edge Medicine Act
Summary
HB4610 revises West Virginia’s Right-to-Try Act by repealing the statute’s legislative findings section and replacing the definitions section with a more detailed framework for access to investigational treatments. The bill defines an “eligible patient” as someone with a life-threatening or severely debilitating illness who has explored FDA-approved options, received a physician recommendation for an investigational drug, biological product, or device, and provided written informed consent. It also excludes inpatients in licensed hospitals from eligibility.
The bill expands and modernizes the definition of “investigational drug, biological product or device” to include products that have completed phase one clinical trials but are not yet FDA-approved, as well as individualized therapies made for a single patient based on genetic profile, including individualized gene therapies, antisense oligonucleotides, and neoantigen vaccines. It also specifies what must be included in written informed consent, including disclosure of risks, possible worsening of symptoms or hastened death, insurance and hospice implications, possible denial of in-home health care, and potential personal or estate liability for costs.
Impact
The bill amends §16-51-3 of the West Virginia Code and repeals §16-51-2, changing the statutory structure of the Right-to-Try Act while leaving the overall policy of access to investigational treatments in place. Its practical effect is to broaden and clarify the types of experimental and individualized therapies covered, while imposing detailed consent requirements and making clear that patients may bear financial responsibility and may lose certain benefits or services when pursuing such treatment. It affects patients with serious illnesses, physicians recommending investigational therapies, manufacturers of such products, insurers, hospice providers, and home health care providers.
Sentiment
The bill appears to have enjoyed strong bipartisan support and little visible opposition. It passed the House 94-0, the Senate 32-0, and then the House again 94-0 on concurrence, indicating broad agreement that the measure should advance. The caption framing it as a “Safeguard” for cutting-edge medicine also suggests a generally favorable posture toward expanding patient access to emerging therapies.
Contention
No committee transcript or recorded floor debate is provided, and the unanimous votes suggest there was little overt contention. The main policy tension inherent in the bill is between expanding access to experimental or individualized treatments for seriously ill patients and ensuring patients understand the risks, costs, and possible loss of insurance, hospice, or home health benefits. Any concerns would likely center on patient safety, informed consent, and financial exposure rather than on the bill’s core purpose.
A bill for an act establishing a veterans recovery pilot program and fund for the reimbursement of expenses related to providing hyperbaric oxygen treatment to eligible veterans and making appropriations.(Formerly HF 326.)
A bill for an act establishing a veterans recovery pilot program and fund for the reimbursement of expenses related to providing hyperbaric oxygen treatment to eligible veterans and making appropriations.(See HF 518.)