Texas § HS.491.053 - CONSORTIUM PROPOSAL

§ HS.491.053. CONSORTIUM PROPOSAL

CONSORTIUM PROPOSAL. (a) The lead institution of higher education of a consortium shall submit to the commission a proposal and request for funding on behalf of the consortium for purposes of conducting ibogaine drug development clinical trials in accordance with this subchapter. (b) A proposal submitted under Subsection (a) must provide: (1) the identity of all consortium members; (2) a detailed description of the planned strategy for obtaining approval for the drug development clinical trials from the United States Food and Drug Administration; (3) a detailed drug development clinical trial design that includes: (A) a description of the composition of the consortium's drug development clinical trial team and the expertise of the team members; (B) a drug development clinical trial participant recruitment plan; (C) patient screening criteria and cardiac safety protocols; (D) administration protocols; (E) an aftercare and post-acute treatment support plan; and (F) a data integrity plan; (4) a detailed plan to seek a breakthrough therapy designation for ibogaine from the United States Food and Drug Administration under 21 U.S.C. Section 356; (5) a proposal to recognize this state's commercial interest in all intellectual property that may be generated over the course of the drug development clinical trials, including: (A) the treatment that is the subject of the trials; (B) administration protocols; (C) treatment models or techniques; and (D) technology used in the trials; (6) a plan to establish a corporate presence in this state and to promote and maintain ibogaine-related biomedical research, development, treatment, manufacturing, and distribution in this state; (7) a plan to secure third-party payor approval for ibogaine treatment following approval by the United States Food and Drug Administration through: (A) private insurers; (B) Medicare; (C) Medicaid; and (D) the TRICARE program of the United States Department of Defense; (8) a plan to ensure ibogaine treatment access to uninsured individuals following approval by the United States Food and Drug Administration; (9) a plan to train and credential medical providers to administer ibogaine treatment according to developed clinical standards; and (10) financial disclosures that verify the consortium's capacity to fully match state funding with funds received from non-state sources. Added by Acts 2025, 89th Leg., R.S., Ch. 333 (S.B. 2308 ), Sec. 1, eff. June 11, 2025.