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.

89(R) SB 2308 - Enrolled version - Bill Text

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

as negotiated in the contract described by Section 491.055,

including verifiable documentation demonstrating the efficient

expenditure of both state and matching funds.

Sec.

491.059.

REPORTING REQUIREMENTS. (a)

A consortium

selected to conduct ibogaine drug development clinical trials shall

quarterly prepare and submit to the commission:

(1)

a report on the progress of the drug development

clinical trials conducted under this subchapter; and

(2)

a financial status report, including information

to verify expenditures of state funds and required matching funds.

(b)

The commission shall submit a report to the legislature

on the progress of the drug development clinical trials conducted

under this subchapter not later than December 1 of each year.

Sec.

491.060.

ALLOCATION OF REVENUE ATTRIBUTABLE TO

INTELLECTUAL PROPERTY AND OTHER RIGHTS. (a)

The revenue

attributable to all intellectual property rights and other

commercial rights arising from drug development clinical trials

conducted by a consortium under this subchapter during the period

for which the trials are funded and any following period of

commercialization shall be allocated as follows:

(1)

not less than 20 percent to the state as specified

in the contract under Section 491.055; and

(2)

the remainder to the members of the consortium in

the amounts specified by written agreement of the members.

(b)

For purposes of this section, intellectual property

rights and other commercial rights arising from the drug

development clinical trials conducted under this subchapter

include any of the following as related to the trials:

(1)

intellectual property, technology, and

inventions;

(2) patents, trademarks, and licenses;

(3) proprietary and confidential information;

(4) trade secrets, data, and databases;

(5) tools, methods, and processes;

(6) treatment models or techniques;

(7) administration protocols; and

(8) works of authorship.

Sec.

491.061.

USE OF STATE REVENUE. (a) The comptroller

shall deposit the revenue received under Section 491.060 to the

credit of the general revenue fund.

(b)

Of the amount deposited under Subsection (a), 25 percent

may be appropriated only to programs that assist veterans in this

state.

(c)

The comptroller shall develop accounting procedures for

the purpose of implementing this section.

SUBCHAPTER C. IBOGAINE TREATMENT ADMINISTRATION

Sec.

491.101.

APPLICABILITY. This subchapter applies only

if ibogaine is approved by the United States Food and Drug

Administration to treat a medical condition.

Sec.

491.102.

MEDICAL SUPERVISION. A physician licensed

under Subtitle B, Title 3, Occupations Code, who has prescribed

ibogaine for a patient shall supervise the administration of

ibogaine at a hospital or other licensed health care facility to

ensure the patient's safety while the patient is under the

influence of ibogaine.

Sec.

491.103.

ADMINISTRATION UNDER FEDERAL LAW. This

subchapter does not preclude a physician from administering

ibogaine in accordance with federal law.

SECTION 2. (a) 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.

(b) The Health and Human Services Commission shall begin

accepting proposals from consortiums under Chapter 491, Health and

Safety Code, as added by this Act, not later than the 60th day after

the effective date of this Act.

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.

______________________________

______________________________

President of the Senate

Speaker of the House

I hereby certify that S.B. No. 2308 passed the Senate on

April 30, 2025, by the following vote: Yeas 26, Nays 5;

May 15, 2025, Senate refused to concur in House amendments and

requested appointment of Conference Committee; May 20, 2025, House

granted request of the Senate; May 31, 2025, Senate adopted

Conference Committee Report by the following vote: Yeas 27,

Nays 4.

______________________________

Secretary of the Senate

I hereby certify that S.B. No. 2308 passed the House, with

amendments, on May 13, 2025, by the following vote: Yeas 138,

Nays 2, two present not voting; May 20, 2025, House granted request

of the Senate for appointment of Conference Committee;

June 1, 2025, House adopted Conference Committee Report by the

following vote: Yeas 134, Nays 4, one present not voting.

______________________________

Chief Clerk of the House

Approved:

______________________________

Date

______________________________

Governor