Bill > HB4626

This bill establishes a grant program administered by the Secretary of Health 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 aims to support a public-private partnership to cover the costs associated with these trials, with the ultimate goal of obtaining approval from the United States Food and Drug Administration (FDA) for ibogaine as a medication. To be eligible for a grant, applicants must be corporate entities with the capacity to conduct these trials, seek FDA approval, and commit to future development in West Virginia, including establishing a corporate presence and promoting ibogaine-related research and treatment within the state. Applicants must also detail their strategy for FDA approval, including trial design, participant recruitment, safety protocols, aftercare plans, and a plan to secure third-party payor approval and ensure access for uninsured individuals. A selection committee composed of experts, philanthropic partners, and legislative designees will review applications and recommend candidates to the Secretary. Upon selection, the applicant must submit an Investigational New Drug (IND) application to the FDA and request a "breakthrough therapy designation," which is a process to expedite the development and review of drugs for serious conditions. Once the IND is approved, drug development trial sites will be established, equipped with cardiac intensive care services, and the trials will commence under the oversight of an institutional review board. Funding for the grant program will come from state appropriations and any gifts, grants, or donations received, with a requirement that grant recipients must match the state funding they receive.