This bill proposes the establishment of a grant program in West Virginia to fund drug development trials for ibogaine, aimed at securing approval from the United States Food and Drug Administration (FDA) for its use in treating opioid use disorder, co-occurring substance use disorders, and other neurological or mental health conditions. The Secretary of Health will oversee the program, which includes preparing a notice of funding opportunity, setting application requirements, and creating a selection committee composed of subject matter experts, philanthropic partners, and legislative designees. The bill outlines the necessary qualifications for applicants, including their capacity to conduct trials, develop treatment protocols, and ensure access to treatment for uninsured individuals.

Additionally, the bill mandates that selected applicants submit an investigational new drug application to the FDA and seek a breakthrough therapy designation for ibogaine. It also requires the establishment of trial sites equipped for cardiac intensive care and the selection of an institutional review board to oversee the trials. Funding for the program will come from state appropriations and donations, with applicants required to match the grant amount they receive. Overall, the bill aims to facilitate the development and approval of ibogaine as a viable treatment option for substance use disorders and related conditions.

Statutes affected:
Engrossed Version: 16-67-1, 16-67-2, 16-67-3, 16-67-4, 16-67-5, 16-67-6, 16-67-7
Introduced Version: 16-67-1, 16-67-2, 16-67-3, 16-67-4, 16-67-5, 16-67-6, 16-67-7