Bill > HB3834

This bill, known as the Oklahoma Breakthrough Therapy Act, establishes a framework for conducting clinical trials of ibogaine, a substance being investigated for therapeutic uses, by defining "drug developer" as an entity engaged in drug development with an agreement to conduct trials for United States Food and Drug Administration (FDA) approval. Before the State Department of Health can contract with a drug developer, the developer must provide a detailed plan for FDA approval, including clinical trial design and a strategy for seeking "breakthrough therapy designation," which aims to expedite the development and review of drugs for serious conditions. The bill also mandates that the drug developer match the state's investment in trials with equal funding, use Oklahoma-based resources where possible, and establish a plan for accessible ibogaine treatment after FDA approval, including priority for state residents and support for uninsured individuals. Furthermore, the bill requires the drug developer to recognize the state's economic interest in any intellectual property generated from the trials, with the state's share of proceeds deposited into a dedicated "Ibogaine Intellectual Property Account" managed by the Office of the State Treasurer, which will then fund programs for at-risk populations. Importantly, the bill prohibits adverse licensing actions against medical professionals for recommending ibogaine therapy services, and requires regular reporting on trial progress and finances to the Legislature, with an effective date of November 1, 2026.

Health and Social Services

http://www.oklegislature.gov/BillInfo.aspx?Bill=hb3834&Session=2600