Bill > HB2075

This bill, titled the "Helping Open Pathways to Effective (HOPE) Treatment Act," establishes a framework for conducting clinical trials in Tennessee for ibogaine, a substance being investigated for treating opioid use disorder, co-occurring substance use disorders, and other neurological or mental health conditions. The Act allows for the creation of "cohorts," which are groups composed of a drug developer (a pharmaceutical or biotechnology company), a research institution (like a university), and a hospital, to apply for state selection to conduct these trials. If selected, a cohort will receive state funding through an interagency agreement with the Department of Mental Health and Substance Abuse Services, provided they secure matching funds from non-state sources. The proposal submitted by a cohort must detail their strategy for obtaining approval from the U.S. Food and Drug Administration (FDA), including trial design, participant recruitment, safety protocols, and plans for seeking "breakthrough therapy designation" from the FDA, which is a process to expedite the development and review of drugs for serious conditions. The bill also emphasizes the state's interest in intellectual property generated from these trials, with a portion of any revenue allocated to a new "Tennessee mental health innovation fund" to support training for behavioral health providers. The Act will only be fully implemented if ibogaine is approved by the FDA for medical use, and it sets a deadline of September 1, 2026, for the state to begin accepting proposals.

Health and Social Services

https://wapp.capitol.tn.gov/apps/Billinfo/default.aspx?BillNumber=HB2075&ga=114