SB2308 - Relating to the establishment of a consortium to conduct United States Food and Drug Administration's drug development clinical trials with ibogaine to secure the administration's approval of the medication's use for treatment of opioid use disorder, co-occurring substance use disorder, and any other neurological or mental health conditions for which ibogaine demonstrates efficacy and to the administration of that treatment.

      S.B. No. 2308         AN ACT   relating to the establishment of a consortium to conduct United   States Food and Drug Administration's drug development clinical   trials with ibogaine to secure the administration's approval of the   medication's use for treatment of opioid use disorder, co-occurring   substance use disorder, and any other neurological or mental health   conditions for which ibogaine demonstrates efficacy and to the   administration of that treatment.          BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:          SECTION 1.  Subtitle C, Title 6, Health and Safety Code, is   amended by adding Chapter 491 to read as follows:   CHAPTER   491.   IBOGAINE TREATMENT   SUBCHAPTER A. GENERAL PROVISIONS           Sec. 491.001.  DEFINITIONS. In this chapter:                 (1)     "Commission" means the Health and Human Services   Commission.                 (2)     "Comptroller" means the comptroller of public   accounts.                 (3)     "Drug developer" means a pharmaceutical company,   biotechnology company, or contract development and manufacturing   organization engaged in drug development and manufacturing.                 (4)     "Hospital" has the meaning assigned by Section   241.003.                 (5)     "Ibogaine" means ibogaine and ibogaine-based   therapeutics, including ibogaine analogs.                 (6)     "Institution of higher education" has the meaning   assigned by Section 61.003, Education Code.   SUBCHAPTER B.   DRUG DEVELOPMENT OF IBOGAINE TREATMENT           Sec.   491.051.     ESTABLISHMENT OF CONSORTIUM. (a)   A   consortium may be established under this section and apply for   commission selection under this subchapter to conduct drug   development clinical trials with ibogaine and secure the United   States Food and Drug Administration's approval of ibogaine as a   medication for the treatment of:                 (1)  opioid use disorder;                 (2)  co-occurring substance use disorder; and                 (3)     any other neurological or mental health condition   for which ibogaine demonstrates efficacy.           (b)     A consortium established under this section must   include one or more of each of the following entities:                 (1)  a drug developer;                 (2)  an institution of higher education; and                 (3)  a hospital.           Sec.   491.052.     LEAD INSTITUTION; ADMINISTRATION; PERSONNEL.     (a)   A consortium established under this subchapter shall select a   lead institution of higher education from among the consortium's   members to represent the consortium and perform administrative   functions under this subchapter, including contracting with and   reporting to the commission as required by this subchapter.           (b)     A consortium selected by the commission under this   subchapter may employ personnel, including clinical,   administrative, and data management personnel, necessary to   support any consortium member's activities related to drug   development clinical trials conducted under this subchapter.           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.           Sec.   491.054.     COMMISSION SELECTION. The commission, in the   commission's sole discretion, shall select a consortium   established in accordance with Section 491.051 for the purpose of   conducting ibogaine drug development clinical trials under this   subchapter.           Sec.   491.055.     CONTRACT WITH LEAD INSTITUTION. (a)   As soon   as practicable after selecting a consortium to conduct ibogaine   drug development clinical trials under Section 491.054, the   commission shall enter into an interagency contract, as provided by   Chapter 771, Government Code, with the lead institution of higher   education of the selected consortium to provide funding to   implement the consortium's proposed ibogaine drug development   clinical trials.           (b)     The interagency contract described by Subsection (a)   must specify:                 (1)     the goals and objectives of the proposed ibogaine   drug development clinical trials;                 (2)  the proposed budget;                 (3)     the timeline for completing the proposed   objectives;                 (4)     the for-profit, nonprofit, or public benefit   corporate entities collaborating with the consortium in the drug   development clinical trials under this subchapter;                 (5)     the percentage of the revenue arising from the   drug development clinical trials to be paid to the state; and                 (6)  any other information required by the commission.           (c)     As soon as practicable after entering into an   interagency contract under Subsection (a), the commission shall   report the existence of the contract to the legislature.           (d)     The commission may not disburse funds to or for a   selected consortium under the interagency contract described by   Subsection (a) until the consortium receives and the commission   verifies the receipt of matching funds from sources other than the   state.             Sec.   491.056.     INVESTIGATIONAL NEW DRUG APPLICATION. On the   commission's notification that a consortium is selected to conduct   the drug development clinical trials under this subchapter, a drug   developer or hospital member of the selected consortium or the lead   institution of higher education of the consortium, as specified by   written agreement of the consortium members, shall, as soon as   practicable:                 (1)     submit an investigational new drug (IND)   application to the United States Food and Drug Administration in   accordance with 21 C.F.R. Part 312; and                 (2)     seek a breakthrough therapy designation for   ibogaine from the United States Food and Drug Administration under   21 U.S.C. Section 356.           Sec.   491.057.     DRUG DEVELOPMENT CLINICAL TRIAL SITES. For   purposes of conducting a drug development clinical trial under this   subchapter, only an institution of higher education or a hospital   may serve as a trial site.           Sec.   491.058.     FUNDING; DISBURSEMENT BY COMMISSION. (a)     The commission and consortium members may solicit and accept gifts,   grants, and donations of any kind received from sources other than   the state for purposes of funding drug development clinical trials   under this subchapter.           (b)     Disbursements of funds by the commission may be made   incrementally based on the completion of clearly defined objectives &#x [Text truncated for display. Full text available on LegiScan.]