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. Eligible applicants must demonstrate the capacity to conduct trials, seek FDA approval, and develop comprehensive plans for trial execution, including patient recruitment and safety protocols.

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 received. This initiative aims to facilitate the research and potential approval of ibogaine as a treatment option, thereby addressing the ongoing opioid crisis and related health issues in the state.

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