89R14527 CJD-F     By: Harris H.B. No. 3717       A BILL TO BE ENTITLED   AN ACT   relating to the establishment of a grant program to fund the United   States Food and Drug Administration's drug development trials with   ibogaine for the purpose of securing the administration's approval   as a medication for treatment of opioid use disorder, co-occurring   substance use disorder, and any other neurological or mental health   conditions for which ibogaine demonstrates efficacy.          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. GRANT PROGRAM FOR DRUG DEVELOPMENT OF IBOGAINE   TREATMENT          Sec. 491.001.  DEFINITIONS. In this chapter:                (1)  "Commission" means the Health and Human Services   Commission.                (2)  "Executive commissioner" means the executive   commissioner of the Health and Human Services Commission.          Sec. 491.002.  RULES. The executive commissioner shall   adopt rules necessary to administer this chapter.          Sec. 491.003.  ESTABLISHMENT OF GRANT PROGRAM. The   commission shall establish and administer a grant program to fund a   public-private partnership program that will pay for the costs of   the United States Food and Drug Administration's drug development   trials with ibogaine to secure the administration's approval as a   medication for treatment of opioid use disorder, co-occurring   substance use disorder, and any other neurological or mental health   conditions for which ibogaine demonstrates efficacy.          Sec. 491.004.  APPLICATION. (a) The commission shall   prepare and issue a notice of funding opportunity to solicit   applications for the grant program established under this chapter.          (b)  An applicant may apply to the commission in the form and   manner prescribed by the commission for a grant under this chapter.     To be eligible for a grant, an applicant must:                (1)  be a for-profit, nonprofit, or public benefit   corporate entity that has the requisite organizational and   financial capacity to:                      (A)  conduct the United States Food and Drug   Administration's drug development trials with ibogaine to secure   the administration's approval as a medication for treatment of   opioid use disorder, co-occurring substance use disorder, and any   other neurological or mental health conditions for which ibogaine   demonstrates efficacy;                      (B)  as a result of the data obtained from the drug   development trial described by Paragraph (A), seek United States   Food and Drug Administration approval of ibogaine; and                      (C)  conduct future drug development trials of   ibogaine as a medication 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                (2)  provide:                      (A)  a detailed description of the planned   strategy for obtaining approval for the drug development trial from   the United States Food and Drug Administration;                      (B)  a detailed drug development trial design that   includes:                            (i)  a description of the composition of the   applicant's drug development trial team and the expertise of the   team members;                            (ii)  a drug development trial participant   recruitment plan;                            (iii)  detailed patient screening criteria   and cardiac safety protocols;                            (iv)  administration protocols;                            (v)  an aftercare and post-acute treatment   support plan; and                            (vi)  a data integrity plan;                      (C)  a proposal to recognize this state's   commercial interest in all patentable intellectual property that   may be generated over the course of the drug development trials,   including:                            (i)  the treatment that is the subject of the   trials;                            (ii)  administration protocols;                            (iii)  treatment models or techniques; and                            (iv)  technology used in the trials;                      (D)  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;                      (E)  a plan to secure third-party payor approval   for ibogaine treatment following approval by the United States Food   and Drug Administration through:                            (i)  private insurers;                            (ii)  Medicare;                            (iii)  Medicaid; and                            (iv)  the TRICARE program of the United   States Department of Defense;                      (F)  a plan to ensure ibogaine treatment access to   uninsured individuals following approval by the United States Food   and Drug Administration;                      (G)  a plan to train and credential medical   providers to administer ibogaine treatment according to developed   clinical standards; and                      (H)  financial disclosures that verify the   applicant's capacity to fully match state funding.          (c)  The commission shall:                (1)  make available the application required under this   section; and                (2)  announce a period of not less than 90 days during   which applicants may submit an application under this chapter.          Sec. 491.005.  SELECTION COMMITTEE. (a) The commission   shall create a selection committee and select the number of   members. The committee must be composed of:                (1)  subject matter experts;                (2)  philanthropic partners; and                (3)  legislative designees.          (b)  The selection committee shall review applications,   communicate supplemental inquiries to applicants, and recommend to   the commission the best applicants to conduct the drug development   trials.          (c)  The commission shall consider the recommendations of   the selection committee in selecting the applicant to conduct the   ibogaine drug development trial.          Sec. 491.006.  INVESTIGATIONAL NEW DRUG APPLICATION. On   notification from the commission that the applicant was selected to   conduct the ibogaine drug development trial, the applicant shall,   as soon as practicable:                (1)  submit an investigational new drug (IND)   application with 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. 491.007.  ESTABLISHMENT OF DRUG DEVELOPMENT TRIAL   SITES. On approval of the applicant's investigational new drug   application by the United States Food and Drug Administration, the   commission shall, in consultation with the applicant, establish   drug development trial sites that must be equipped and staffed to   provide cardiac intensive care services to patients.          Sec. 491.008.  CONDUCTING DRUG DEVELOPMENT TRIAL. (a) As   soon as practicable after drug development trial sites are   established under Section 491.007, the applicant shall begin a drug   development trial to administer treatment with ibogaine.          (b)  The commission, in consultation with the selection   committee under Section 491.005, shall select an institutional   review board with a presence in this state to oversee and verify the   drug development trial research activity for scientific validation   and authentication under the requirements of the United States Food   and Drug Administration.          (c)  The applicant shall request the designation under 21   U.S.C. Section 356 during the drug development trial if the   ibogaine treatment is demonstrating efficacy.          Sec. 491.009.  FUNDING. (a)  The commission may use money   appropriated to the commission and money received as a gift, grant,   or donation to pay for a grant under this chapter. The commission   may solicit and accept gifts, grants, and donations of any kind and   from any source for purposes of this section.          (b)  An applicant selected to perform a drug development   trial under this chapter shall contribute toward the cost of   developing the ibogaine treatment an amount of money that is at   least equal to the amount of money that the applicant received in   the form of a grant from the commission.          SECTION 2.  If before implementing any provision of this Act   a state agency determines that a waiver or authorization from a   federal agency is necessary for implementation of that provision,   the agency affected by the provision shall request the waiver or   authorization and may delay implementing that provision until the   waiver or authorization is granted.          SECTION 3.  This Act takes effect immediately if it receives   a vote of two-thirds of all the members elected to each house, as   provided by Section 39, Article III, Texas Constitution.  If this   Act does not receive the vote necessary for immediate effect, this   Act takes effect September 1, 2025.