Virginia HB 1025: Access to investigational drugs, etc.; patient with severely debilitating condition.

Bill Text

2026 SESSION

INTRODUCED

26102452D

HOUSE BILL NO. 1025

Offered January 14, 2026

Prefiled January 14, 2026

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.

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Patrons—Walker and Williams

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Referred to Committee on Health and Human Services

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Be it enacted by the General Assembly of Virginia:

1. That §§ 54.1-3442.1, 54.1-3442.2, and 54.1-3442.3 of the Code of Virginia are amended and reenacted as follows:

§ 54.1-3442.1. Definitions.

As used in this article, unless the context requires a different meaning:

"Investigational drug, biological product, or device" means a drug, biological product, or device that has successfully completed Phase I of a clinical trial but has not been approved for general use by the U.S. Food and Drug Administration and remains under investigation in a clinical trial.

"Severely debilitating condition" means a disease or condition that causes major irreversible morbidity.

"Terminal condition" means a condition caused by injury, disease, or illness from which, to a reasonable degree of medical probability, a patient cannot recover and (i) the patient's death is imminent or (ii) the patient is in a persistent vegetative state. 

"Treating physician" means a physician who is providing or has previously provided medical treatment or evaluation to and has or previously had an ongoing treatment relationship with the person.

§ 54.1-3442.2. Eligibility for expanded access to investigational drugs, biological products, and devices; written, informed consent to treatment.

A. A person shall be eligible for expanded access to investigational drugs, biological products, or devices if:

1. He has a terminal or severely debilitating condition, attested to by his treating physician and confirmed by a second physician not previously involved in the treatment of the person who has conducted an independent examination of the person;

2. He has, in consultation with his treating physician, considered all other treatment options currently approved by the U.S. Food and Drug Administration and the treating physician has determined that no reasonable opportunity exists for him to participate in an ongoing clinical trial for his terminal or severely debilitating condition;

3. The potential benefits of use of the investigational drug, biological product, or device to treat his terminal or severely debilitating condition are greater than the potential risks of the use of the investigational drug, biological product, or device to treat his terminal or severely debilitating condition;

4. He has received a recommendation from his treating physician for use of an investigational drug, biological product, or device for treatment of his terminal or severely debilitating condition; and

5. He or, if he is incapable of making an informed decision, his legally authorized representative has given written informed consent to use of the investigational drug, biological product, or device for treatment of his terminal or severely debilitating condition or, if the person is a minor or lacks capacity to provide informed consent, his parent or legal guardian has given written informed consent to the use of the investigational drug, biological product, or device for treatment of his terminal or severely debilitating condition.

Documentation indicating that the person meets the criteria for eligibility for expanded access to investigational drugs, biological products, or devices shall be provided by the person's treating physician and shall be included in the person's medical record.

B. Written informed consent to use of an investigational drug, biological product, or device shall include:

1. An explanation of the currently approved products and treatments for the person's terminal or severely debilitating condition;

2. A statement that the person has, in consultation with his treating physician, considered all other treatment options currently approved by the U.S. Food and Drug Administration and the treating physician has determined that no reasonable opportunity exists for the person to participate in an ongoing clinical trial for his terminal or severely debilitating condition;

3. An explanation of the specific investigational drug, biological product, or device proposed for treatment of the person's terminal or severely debilitating condition;

4. A description of possible outcomes resulting from use of the investigational drug, biological product, or device to treat the person's terminal or severely debilitating condition, including a statement that new, unanticipated, different, or worse symptoms might result from and death could be hastened by the proposed treatment, based on the treating physician's knowledge of the proposed treatment in conjunction with an awareness of the person's terminal or severely debilitat