The proposed bill aims to establish a grant program in West Virginia to fund drug development trials for ibogaine, a substance being explored for its potential in treating opioid use disorder and other mental health conditions. The Secretary of Health will oversee the program, which includes preparing a notice of funding opportunity, setting application requirements, and forming a selection committee composed of subject matter experts, philanthropic partners, and legislative designees. Applicants must demonstrate their capacity to conduct trials, provide detailed plans for trial execution, and ensure access to treatment for uninsured individuals.

Additionally, the bill outlines the process for submitting an investigational new drug application to the FDA and seeking a breakthrough therapy designation for ibogaine. It mandates 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 selected applicants required to match the grant amount they receive. This comprehensive approach aims to facilitate the development and approval of ibogaine as a viable treatment option.

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