Bill > HB3834

This bill, known as the Oklahoma Breakthrough Therapy Act, establishes a framework for the State Department of Health to contract with "drug developers" – entities involved in developing and manufacturing drugs, specifically ibogaine and related therapeutics, that have agreements with other states to conduct clinical trials aiming for U.S. Food and Drug Administration (FDA) approval. Before contracting, drug developers must present a detailed plan for FDA approval, including clinical trial design, participant recruitment, and plans for investigational new drug applications and breakthrough therapy designations, along with proof of agreements with other states and financial disclosures. The contract will require the drug developer to match the state's investment in trials, conduct them within Oklahoma using local resources where possible, report on progress and finances quarterly, and establish plans for accessible ibogaine treatment post-FDA approval, including priority access for state residents, seeking insurance coverage, and developing options for uninsured and low-income individuals. The contract will also address the state's economic interest in intellectual property generated from these trials, ensuring Oklahoma receives a proportional share of proceeds. The bill creates the Ibogaine Development Revolving Fund to receive these proceeds and other sources, which the Department can use to support programs and research for conditions treatable with ibogaine, such as traumatic brain injury and opioid use disorder. Furthermore, medical professionals recommending participation in ibogaine clinical trials will be protected from disciplinary action solely for doing so. The act will become effective on November 1, 2026.