Texas § 491.053 CONSORTIUM PROPOSAL.

Texas Statutes

§ 491.053 — CONSORTIUM PROPOSAL.

Texas § 491.053

Code HSHealth and Safety Code

This text of Texas § 491.053 (CONSORTIUM PROPOSAL.) is published on Counsel Stack Legal Research, covering Texas primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook

Tex. Health and Safety Code Code Ann. § 491.053 (2026).

Text

Sec. 491.053. 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

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Sec. 491.053. 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.