Bill > HB3834

This bill, known as the Oklahoma Breakthrough Therapy Act, establishes a framework for conducting clinical trials for ibogaine, a substance being investigated for therapeutic use, and aims to facilitate its approval by the United States Food and Drug Administration (FDA). It defines a "drug developer" as an entity involved in drug development that has an agreement with at least one other state to conduct ibogaine clinical trials. Before the State Department of Health can contract with a drug developer, the developer must present a detailed plan for FDA approval, including clinical trial design, participant recruitment, and aftercare protocols, and demonstrate an existing agreement with another state, along with sufficient financial disclosures. The contract will require the drug developer to match the state's investment in trials with an equal amount of funding, conduct trials within Oklahoma using local resources where possible, and report on progress and finances. Furthermore, the contract must include a plan to ensure accessible ibogaine treatment within the state after FDA approval, prioritizing residents, seeking insurance coverage, providing options for the uninsured and low-income, and training medical providers. The bill also addresses intellectual property rights, stipulating that the state will receive a proportional share of proceeds from any intellectual property generated from these trials, which will be deposited into a dedicated "Ibogaine Intellectual Property Account" managed by the Office of the State Treasurer, with funds to be used for programs benefiting at-risk populations with conditions treatable by ibogaine. Importantly, the bill prohibits adverse licensing actions against medical professionals in Oklahoma for recommending ibogaine therapy services.

Budget and Finance, Health and Social Services

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