A BILL to amend and reenact §§ 54.1-3442.1, 54.1-3442.2, and 54.1-3442.3 of the Code of Virginia, relating to access to investigational drugs, biological products, and devices; patient with severely debilitating condition.
HB1025 would revise Virginia’s “expanded access” or “right-to-try” style rules for investigational drugs, biological products, and devices. The bill keeps the basic framework that allows a patient with a terminal or severely debilitating condition to seek access to a treatment that has completed Phase I clinical testing but has not yet been approved by the FDA, while adding and clarifying eligibility and consent requirements. It defines “severely debilitating condition” as one causing major irreversible morbidity and retains the existing definition of a terminal condition.
Under the bill, a patient would qualify only if a treating physician and a second, independent physician confirm the condition, the patient has considered FDA-approved alternatives, no reasonable clinical trial opportunity exists, and the treating physician believes the potential benefits outweigh the risks. The bill also requires detailed written informed consent, including disclosure of approved alternatives, the investigational nature of the product, possible adverse outcomes, and the possibility that treatment could hasten death. Documentation of eligibility must be placed in the medical record.
HB1025 also addresses who may provide and pay for these treatments. Manufacturers may choose to make investigational products available, but are not required to do so. If they do provide access, they may charge the patient for manufacturing-related costs or provide the product free of charge. The bill similarly states that insurers and health plans may cover related costs, but are not required to do so.
The bill’s impact on state law would be to amend three sections of the Virginia Code governing investigational treatment access, expanding the statute’s applicability from terminal conditions to include severely debilitating conditions and tightening procedural safeguards around physician certification and informed consent. It would affect patients with serious illnesses, treating physicians, manufacturers of investigational products, and insurers, but it would not create a mandate for manufacturers or insurers to participate or pay.
The overall sentiment reflected in the bill text is supportive of patient access while emphasizing caution and informed decision-making. Because there are no recorded committee transcripts or votes, there is no documented floor or committee debate to indicate broader political sentiment. The main point of contention inherent in the bill is the balance between expanding access for seriously ill patients and preserving manufacturer and insurer discretion, along with the added medical and consent requirements that may limit use in practice.
HB1025 would amend §§ 54.1-3442.1, 54.1-3442.2, and 54.1-3442.3 of the Code of Virginia to broaden and clarify the state’s investigational-treatment access provisions. It would extend eligibility to patients with a “severely debilitating condition,” add a statutory definition for that term, and require confirmation by a second physician, detailed informed consent, and medical-record documentation. The bill would also preserve existing non-mandatory language for manufacturers and insurers, meaning it authorizes but does not compel access, coverage, or payment for investigational products.
The bill appears generally pro-access and patient-centered, aiming to give patients with severe or terminal illnesses another treatment option when approved therapies and clinical trials are unavailable. At the same time, it is cautious and procedural, reflecting concern about safety, physician oversight, and informed consent. No committee transcript or vote record is available, so there is no evidence of organized support or opposition beyond the bill’s structure and language.
The principal tension in HB1025 is between expanding access for patients with major irreversible morbidity and limiting risk through strict eligibility, physician certification, and consent requirements. Another likely point of contention is that the bill does not require manufacturers to provide investigational products or insurers to cover them, which may frustrate advocates seeking meaningful access, while opponents may still view the expanded eligibility as too permissive. The inclusion of language warning that treatment could hasten death and may involve patient-paid costs underscores the bill’s effort to balance hope with caution.