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89(R) SR 703 - Enrolled version - Bill Text
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;
(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.
Explanation: The change is necessary to specify the
information required for submission of a proposal under Section
491.053, Health and Safety Code, and selection to perform drug
development clinical trials under added Chapter 491, Health and
Safety Code.
(9) 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 Section 491.005, Health and Safety
Code. The omitted text reads:
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.
Explanation: The change is necessary to remove the
selection committee.
(10) 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 491.054 and 491.055, Health and Safety Code,
to read as follows:
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.
Explanation: The change is necessary to allow the Health
and Human Services Commission to select a consortium established
under added Chapter 491, Health and Safety Code, for the purpose
of conducting drug development clinical trials under that
chapter, to require the commission to enter into an interagency
contract with the consortium for the conduct of those trials, and
to regulate the contract provisions and the disbursement of funds
to the selected consortium.
(11) Senate Rules 12.03(1) and (3) are suspended to
permit the committee to change, alter, or amend text not in
disagreement and add text on a matter not in disagreement in
proposed SECTION 1 of the bill, by adding Section 491.056, Health
and Safety Code, to read as follows:
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.
Explanation: The change is necessary to allow certain
members of a consortium established under added Chapter 491,
Health and Safety Code, to apply for an investigational new drug
application with the United States Food and Drug Administration
and to seek from the administration a breakthrough therapy
designation for certain treatments.
(12) 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 Section 491.057, Health and Safety Code, to read as
follows:
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.
Explanation: The change is necessary to specify which
members of a consortium established under added Chapter 491,
Health and Safety Code, may serve as a drug development clinical
trial site under that chapter.
(13) 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 491.007 and 491.008,
Health and Safety Code. The omitted text reads:
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.
Explanation: The change is necessary to remove
requirements relating to drug development trial sites and the
conduct of a drug development trial.
(14) Senate Rules 12.03(1), (2), and (4) are suspended to
permit the committee to change, alter, or amend text not in
disagreement, omit text on a matter not in disagreement, and 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
Section 491.058, Health and Safety Code, to read as follows:
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.
Explanation: The change is necessary to clarify that
matching funds provided by a consortium established under added
Chapter 491, Health and Safety Code, must come from sources other
than the state, and to add accountability requirements.
(15) 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 Section 491.009(b), Health and
Safety Code. The omitted text reads:
(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.
Explanation: The change is necessary to eliminate
duplicative and conflicting provisions relating to matching
funds.
(16) 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 491.059, 491.060, and 491.061, Health and
Safety Code, to read as follows:
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.
Explanation: The change is necessary to establish
reporting requirements for a consortium established under added
Chapter 491, Health and Safety Code, and to clarify the
allocation of revenues attributable to certain property rights
under that chapter.
(17) 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 2 of the bill,
by adding Subsection (b) to read as follows:
(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.
Explanation: The change is necessary to require the
Health and Human Services Commission to begin accepting
proposals from consortiums under added Chapter 491, Health and
Safety Code, by a certain date.
_______________________________
President of the Senate
I hereby certify that the
above Resolution was adopted by
the Senate on May 31, 2025, by the
following vote: Yeas 31, Nays 0.
_______________________________
Secretary of the Senate