Bill > HB6020

This bill establishes an "ibogaine grant program" within the Department of Health and Human Services to fund certified clinical drug development trials for ibogaine, a substance being researched for its potential to treat opioid use disorder, co-occurring substance use disorder, and other neurological or mental health conditions. To receive grants, entities must be located in Michigan, have proven research and treatment experience in neurological diseases and substance dependence, possess a neurosurgery program with advanced clinical and research capabilities including cardiac intensive care, and demonstrate the ability to facilitate pioneering research. They must also either have an agreement with an out-of-state consortium that has submitted an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) for ibogaine and is seeking breakthrough therapy designation, or be part of a Michigan-based consortium that is pursuing these FDA applications. The bill also creates the "ibogaine research fund" to hold money from clinical trials and other sources, which will be administered by the Department of Health and Human Services for the grant program. Furthermore, it outlines that ibogaine, when used in these approved research programs or when prescribed and administered by a physician in compliance with specific regulations, will not be considered a Schedule 1 controlled substance, which is a classification for drugs with no currently accepted medical use and a high potential for abuse. The bill also allows for the facilitation of a consortium of Michigan entities, drug developers, institutions of higher education, hospitals, and other states to conduct these trials, requiring such a consortium to submit an IND and pursue breakthrough therapy designation before receiving state funds. Finally, it clarifies that physicians can prescribe and supervise the administration of ibogaine at licensed facilities if it is approved by the FDA for a medical condition, ensuring patient safety and adherence to established protocols.