Bill > HB1025

This bill expands access to investigational drugs, biological products, and devices, which are treatments that have passed initial safety testing but are not yet approved for general use by the U.S. Food and Drug Administration (FDA), to patients with a "severely debilitating condition," defined as a disease or condition causing major irreversible harm, not just those with a "terminal condition" (a condition where recovery is unlikely and death is imminent or the patient is in a persistent vegetative state). The bill outlines specific criteria for eligibility, including attestation from two physicians, consideration of all other FDA-approved treatments, a determination that the potential benefits outweigh the risks, and written informed consent from the patient or their legal representative, detailing the proposed treatment, potential outcomes, and costs. It also clarifies that while manufacturers may provide these treatments for free or charge for costs, and insurers may choose to cover related expenses, neither is required to do so.

Health and Social Services

https://lis.virginia.gov/bill-details/20261/HB1025