Bill > HB4626

This bill establishes a grant program in West Virginia to fund drug development trials for ibogaine, a substance being investigated for its potential to treat opioid use disorder, co-occurring substance use disorders, and other neurological or mental health conditions. The program, administered by the Secretary of Health, will support a public-private partnership to cover the costs associated with these trials, aiming to secure approval from the United States Food and Drug Administration (FDA) as a medication. Applicants must be entities with the capacity to conduct these trials, seek FDA approval, and plan for future development, including establishing a corporate presence in the state and ensuring access to treatment for uninsured individuals. A selection committee composed of experts, philanthropic partners, and legislative designees will review applications and recommend candidates to the Secretary. Once an applicant is selected, they must submit an Investigational New Drug (IND) application to the FDA, which is a formal submission to allow for clinical testing of a new drug, and also request a "breakthrough therapy designation" from the FDA, a process designed to expedite the development and review of drugs for serious or life-threatening conditions. After the IND application is approved, drug development trial sites will be established, and the trials will commence under the oversight of an institutional review board. The program will be funded through state appropriations and private donations, with a requirement that selected applicants match the grant funding they receive.

Budget and Finance, Health and Social Services

http://www.wvlegislature.gov/Bill_Status/Bills_history.cfm?input=4626&year=2026&sessiontype=RS&btype=bill