Texas 2025 - 89th Regular

Texas Senate Bill SB2308 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	89R15836 CJD-D
2	2	By: Parker S.B. No. 2308
3	3
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6	6
7	7	A BILL TO BE ENTITLED
8	8	AN ACT
9	9	relating to the establishment of a grant program to fund the United
10	10	States Food and Drug Administration's drug development trials with
11	11	ibogaine for the purpose of securing the administration's approval
12	12	as a medication for treatment of opioid use disorder, co-occurring
13	13	substance use disorder, and any other neurological or mental health
14	14	conditions for which ibogaine demonstrates efficacy and the
15	15	administration of that treatment.
16	16	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
17	17	SECTION 1. Subtitle C, Title 6, Health and Safety Code, is
18	18	amended by adding Chapter 491 to read as follows:
19	19	CHAPTER 491. IBOGAINE TREATMENT
20	20	SUBCHAPTER A. GRANT PROGRAM FOR DRUG DEVELOPMENT OF IBOGAINE
21	21	TREATMENT
22	22	Sec. 491.001. DEFINITIONS. In this chapter:
23	23	(1) "Commission" means the Health and Human Services
24	24	Commission.
25	25	(2) "Executive commissioner" means the executive
26	26	commissioner of the Health and Human Services Commission.
27	27	Sec. 491.002. RULES. The executive commissioner shall
28	28	adopt rules necessary to administer this chapter.
29	29	Sec. 491.003. ESTABLISHMENT OF GRANT PROGRAM. The
30	30	commission shall establish and administer a grant program to fund a
31	31	public-private partnership program that will pay for the costs of
32	32	the United States Food and Drug Administration's drug development
33	33	trials with ibogaine to secure the administration's approval as a
34	34	medication for treatment of opioid use disorder, co-occurring
35	35	substance use disorder, and any other neurological or mental health
36	36	conditions for which ibogaine demonstrates efficacy.
37	37	Sec. 491.004. APPLICATION. (a) The commission shall
38	38	prepare and issue a notice of funding opportunity to solicit
39	39	applications for the grant program established under this
40	40	subchapter.
41	41	(b) An applicant may apply to the commission in the form and
42	42	manner prescribed by the commission for a grant under this
43	43	subchapter. To be eligible for a grant, an applicant must:
44	44	(1) be a for-profit, nonprofit, or public benefit
45	45	corporate entity that has the requisite organizational and
46	46	financial capacity to:
47	47	(A) conduct the United States Food and Drug
48	48	Administration's drug development trials with ibogaine to secure
49	49	the administration's approval as a medication for treatment of
50	50	opioid use disorder, co-occurring substance use disorder, and any
51	51	other neurological or mental health conditions for which ibogaine
52	52	demonstrates efficacy;
53	53	(B) as a result of the data obtained from the drug
54	54	development trial described by Paragraph (A), seek United States
55	55	Food and Drug Administration approval of ibogaine; and
56	56	(C) conduct future drug development trials of
57	57	ibogaine as a medication for treatment of opioid use disorder,
58	58	co-occurring substance use disorder, and any other neurological or
59	59	mental health conditions for which ibogaine demonstrates efficacy;
60	60	and
61	61	(2) provide:
62	62	(A) a detailed description of the planned
63	63	strategy for obtaining approval for the drug development trial from
64	64	the United States Food and Drug Administration;
65	65	(B) a detailed drug development trial design that
66	66	includes:
67	67	(i) a description of the composition of the
68	68	applicant's drug development trial team and the expertise of the
69	69	team members;
70	70	(ii) a drug development trial participant
71	71	recruitment plan;
72	72	(iii) detailed patient screening criteria
73	73	and cardiac safety protocols;
74	74	(iv) administration protocols;
75	75	(v) an aftercare and post-acute treatment
76	76	support plan; and
77	77	(vi) a data integrity plan;
78	78	(C) a proposal to recognize this state's
79	79	commercial interest in all patentable intellectual property that
80	80	may be generated over the course of the drug development trials,
81	81	including:
82	82	(i) the treatment that is the subject of the
83	83	trials;
84	84	(ii) administration protocols;
85	85	(iii) treatment models or techniques; and
86	86	(iv) technology used in the trials;
87	87	(D) a plan to establish a corporate presence in
88	88	this state and to promote and maintain ibogaine-related biomedical
89	89	research, development, treatment, manufacturing, and distribution
90	90	in this state;
91	91	(E) a plan to secure third-party payor approval
92	92	for ibogaine treatment following approval by the United States Food
93	93	and Drug Administration through:
94	94	(i) private insurers;
95	95	(ii) Medicare;
96	96	(iii) Medicaid; and
97	97	(iv) the TRICARE program of the United
98	98	States Department of Defense;
99	99	(F) a plan to ensure ibogaine treatment access to
100	100	uninsured individuals following approval by the United States Food
101	101	and Drug Administration;
102	102	(G) a plan to train and credential medical
103	103	providers to administer ibogaine treatment according to developed
104	104	clinical standards; and
105	105	(H) financial disclosures that verify the
106	106	applicant's capacity to fully match state funding.
107	107	(c) The commission shall:
108	108	(1) make available the application required under this
109	109	section; and
110	110	(2) announce a period of not less than 90 days during
111	111	which applicants may submit an application under this subchapter.
112	112	Sec. 491.005. SELECTION COMMITTEE. (a) The commission
113	113	shall create a selection committee and select the number of
114	114	members. The committee must be composed of:
115	115	(1) subject matter experts;
116	116	(2) philanthropic partners; and
117	117	(3) legislative designees.
118	118	(b) The selection committee shall review applications,
119	119	communicate supplemental inquiries to applicants, and recommend to
120	120	the commission the best applicants to conduct the drug development
121	121	trials.
122	122	(c) The commission shall consider the recommendations of
123	123	the selection committee in selecting the applicant to conduct the
124	124	ibogaine drug development trial.
125	125	Sec. 491.006. INVESTIGATIONAL NEW DRUG APPLICATION. On
126	126	notification from the commission that the applicant was selected to
127	127	conduct the ibogaine drug development trial, the applicant shall,
128	128	as soon as practicable:
129	129	(1) submit an investigational new drug (IND)
130	130	application with the United States Food and Drug Administration in
131	131	accordance with 21 C.F.R. Part 312; and
132	132	(2) seek a breakthrough therapy designation for
133	133	ibogaine from the United States Food and Drug Administration under
134	134	21 U.S.C. Section 356.
135	135	Sec. 491.007. ESTABLISHMENT OF DRUG DEVELOPMENT TRIAL
136	136	SITES. On approval of the applicant's investigational new drug
137	137	application by the United States Food and Drug Administration, the
138	138	commission shall, in consultation with the applicant, establish
139	139	drug development trial sites that must be equipped and staffed to
140	140	provide cardiac intensive care services to patients.
141	141	Sec. 491.008. CONDUCTING DRUG DEVELOPMENT TRIAL. (a) As
142	142	soon as practicable after drug development trial sites are
143	143	established under Section 491.007, the applicant shall begin a drug
144	144	development trial to administer treatment with ibogaine.
145	145	(b) The commission, in consultation with the selection
146	146	committee under Section 491.005, shall select an institutional
147	147	review board with a presence in this state to oversee and verify the
148	148	drug development trial research activity for scientific validation
149	149	and authentication under the requirements of the United States Food
150	150	and Drug Administration.
151	151	(c) The applicant shall request the designation under 21
152	152	U.S.C. Section 356 during the drug development trial if the
153	153	ibogaine treatment is demonstrating efficacy.
154	154	Sec. 491.009. FUNDING. (a) The commission may use money
155	155	received as a gift, grant, or donation to pay for a grant under this
156	156	subchapter. The commission may solicit and accept gifts, grants,
157	157	and donations of any kind and from any source for purposes of this
158	158	section.
159	159	(b) An applicant selected to perform a drug development
160	160	trial under this subchapter shall contribute toward the cost of
161	161	developing the ibogaine treatment an amount of money that is at
162	162	least equal to the amount of money that the applicant received in
163	163	the form of a grant from the commission.
164	164	SUBCHAPTER B. IBOGAINE TREATMENT ADMINISTRATION
165	165	Sec. 491.051. APPLICABILITY. This subchapter applies only
166	166	if ibogaine is approved by the United States Food and Drug
167	167	Administration to treat a medical condition.
168	168	Sec. 491.052. MEDICAL SUPERVISION. A physician licensed
169	169	under Subtitle B, Title 3, Occupations Code, who has prescribed
170	170	ibogaine for a patient shall supervise the administration of
171	171	ibogaine at a hospital or other licensed health care facility to
172	172	ensure the patient's safety while the patient is under the
173	173	influence of ibogaine.
174	174	Sec. 491.053. ADMINISTRATION UNDER FEDERAL LAW PERMITTED.
175	175	This subchapter does not preclude a physician from otherwise
176	176	administering ibogaine according to federal law.
177	177	SECTION 2. If before implementing any provision of this Act
178	178	a state agency determines that a waiver or authorization from a
179	179	federal agency is necessary for implementation of that provision,
180	180	the agency affected by the provision shall request the waiver or
181	181	authorization and may delay implementing that provision until the
182	182	waiver or authorization is granted.
183	183	SECTION 3. This Act takes effect immediately if it receives
184	184	a vote of two-thirds of all the members elected to each house, as
185	185	provided by Section 39, Article III, Texas Constitution. If this
186	186	Act does not receive the vote necessary for immediate effect, this
187	187	Act takes effect September 1, 2025.