SR703 - Suspending limitations on conference committee jurisdiction, S.B. No. 2308.

      By: Parker S.R. No. 703       SENATE RESOLUTION          BE IT RESOLVED by the Senate of the State of Texas, 89th   Legislature, Regular Session, 2025, That Senate Rule 12.03 be   suspended in part as provided by Senate Rule 12.08 to enable the   conference committee appointed to resolve the differences on   Senate Bill 2308 (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) to consider and take action on the following matters:          (1)  Senate Rule 12.03(2) is suspended to permit the   committee to omit text not in disagreement by omitting in   proposed SECTION 1 of the bill added Section 491.001(2), Health   and Safety Code.  The omitted text reads:                 (2)     "Executive commissioner" means the executive   commissioner of the Health and Human Services Commission.          Explanation: The change is necessary to remove a   definition that no longer appears in added Chapter 491, Health   and Safety Code.          (2)  Senate Rule 12.03(4) is suspended to permit the   committee to add text on a matter not included in either the house   or senate version of the bill in proposed SECTION 1 of the bill,   by adding Sections 491.001(2), (3), (4), and (6), Health and   Safety Code, to read as follows:                 (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.                 (6)     "Institution of higher education" has the   meaning assigned by Section 61.003, Education Code.          Explanation: The change is necessary to define   "comptroller," "drug developer," "hospital," and "institution of   higher education" for purposes of added Chapter 491, Health and   Safety Code.          (3)  Senate Rule 12.03(2) is suspended to permit the   committee to omit text not in disagreement in proposed SECTION 1   of the bill by omitting added Sections 491.002 and 491.003,   Health and Safety Code. The omitted text reads:           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.          Explanation: The change is necessary to eliminate   rulemaking authority and remove a grant program.          (4)  Senate Rule 12.03(4) is suspended to permit the   committee to add text on a matter not included in either the house   or senate version of the bill in proposed SECTION 1 of the bill,   by adding a heading for added Subchapter B, Chapter 491, Health   and Safety Code, to read as follows:   SUBCHAPTER B. DRUG DEVELOPMENT OF IBOGAINE TREATMENT          Explanation: The change is necessary for better   organization of added Chapter 491, Health and Safety Code.          (5)  Senate Rule 12.03(4) is suspended to permit the   committee to add text on a matter not included in either the house   or senate version of the bill in proposed SECTION 1 of the bill,   by adding Sections 491.051 and 491.052, Health and Safety Code,   to read as follows:           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.          Explanation: The change is necessary to allow formation   of a consortium for the conduct of certain drug development   clinical trials, to secure United States Food and Drug   Administration's approval for certain medical treatments, and to   allow the consortium to select a lead institution and employ   necessary personnel.          (6)  Senate Rule 12.03(2) is suspended to permit the   committee to omit text not in disagreement in proposed SECTION 1   of the bill by omitting the heading and Subsections (a) and (c) of   added Section 491.004, Health and Safety Code. The omitted text   reads:           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   subchapter.           (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   subchapter.          Explanation: The change is necessary to remove an   application process for a removed grant program.          (7)  Senate Rule 12.03(4) is suspended to permit the   committee to add text on a matter not included in either the house   or senate version of the bill in proposed SECTION 1 of the bill,   by adding a heading and Subsection (a) for Section 491.053,   Health and Safety Code, to read as follows:           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.          Explanation: The change is necessary to require a   consortium formed under added Chapter 491, Health and Safety   Code, to submit to the Health and Human Services Commission a   proposal for selection to conduct a drug development clinical   trial under that chapter.          (8)  Senate Rules 12.03(1), (2), and (3) are suspended to   permit the committee to change, alter, or amend text not in   disagreement, omit text not in disagreement, and add text on a   matter not in disagreement in proposed SECTION 1 of the bill, by   adding Section 491.053(b), Health and Safety Code, to read as   follows:           (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;      & [Text truncated for display. 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