89R15836 CJD-D
By: Parker S.B. No. 2308
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 and 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. 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
subchapter.
(b) An applicant may apply to the commission in the form and
manner prescribed by the commission for a grant under this
subchapter. 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 subchapter.
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
received as a gift, grant, or donation to pay for a grant under this
subchapter. 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 subchapter 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.
SUBCHAPTER B. IBOGAINE TREATMENT ADMINISTRATION
Sec. 491.051. APPLICABILITY. This subchapter applies only
if ibogaine is approved by the United States Food and Drug
Administration to treat a medical condition.
Sec. 491.052. 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. 491.053. ADMINISTRATION UNDER FEDERAL LAW PERMITTED.
This subchapter does not preclude a physician from otherwise
administering ibogaine according to federal law.
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.