S.B. No. 2308 establishes a consortium dedicated to conducting clinical trials for the drug ibogaine, aiming to obtain FDA approval for its use in treating opioid use disorder, co-occurring substance use disorder, and other neurological or mental health conditions. The bill introduces Chapter 491 to the Health and Safety Code, detailing the consortium's formation, membership requirements—including a drug developer, an institution of higher education, and a hospital—and the responsibilities of the lead institution, which will manage administrative functions and submit funding proposals for the trials. The consortium is required to report quarterly on trial progress and financial status, with a stipulation that at least 20% of any revenue from resulting intellectual property will be allocated to the state.
Additionally, the bill includes a new subchapter regarding the administration of ibogaine, which is contingent upon FDA approval. It mandates that a licensed physician supervise ibogaine administration in a hospital or licensed healthcare facility to ensure patient safety, while also clarifying that physicians may administer ibogaine in accordance with federal law. The bill allows state agencies to delay implementation of provisions if a federal waiver or authorization is needed and tasks the Health and Human Services Commission with accepting proposals from consortiums within 60 days of the bill's effective date. The bill will take effect immediately upon a two-thirds vote from both houses or on September 1, 2025, if such a vote is not achieved.
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