S.B. No. 2308 aims to establish a consortium for conducting clinical trials on ibogaine, a substance being considered for FDA approval to treat opioid use disorder and other related conditions. The bill introduces Chapter 491 to the Health and Safety Code, which outlines the consortium's formation, requiring participation from a drug developer, an institution of higher education, and a hospital. The lead institution will handle administrative tasks and submit funding proposals for the trials. The bill also specifies the consortium's proposal requirements, including plans for FDA approval, trial design, participant recruitment, and aftercare support, while ensuring that at least 20% of the revenue generated from the trials is allocated to the state to support veteran programs.
Additionally, the bill includes a new subchapter regarding the administration of ibogaine, which will only apply if the substance receives FDA approval. It mandates that a licensed physician supervise ibogaine administration in healthcare facilities to ensure patient safety. The bill also allows state agencies to delay implementation of its provisions until necessary federal waivers or authorizations are obtained. The Health and Human Services Commission is tasked with accepting proposals from consortiums within 60 days of the Act's effective date, which will take effect immediately upon a two-thirds vote from both legislative houses or on September 1, 2025, if not.
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