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28	28	STATE OF OKLAHOMA
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30	30	2nd Session of the 58th Legislature (202 2)
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32	32	HOUSE BILL 3174 By: Phillips
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38	38	AS INTRODUCED
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40	40	An Act relating to public health; defining terms;
41	41	providing for the establishment of statewide
42	42	investigational new drug applications fo r psilocybin
43	43	clinical trials; authorizing physicians to serve as
44	44	principal investigators for clinical trials under
45	45	certain circumstances; providing for
46	46	subinvestigators; directing investigators and
47	47	subinvestigators to adhere to certain rules and
48	48	regulations; permitting Oklahoma State Bureau of
49	49	Narcotics and Dangerous Drugs Control to inspect
50	50	certain samples; providing guidelines for conducting
51	51	clinical trials; exempting person acting in
52	52	compliance from criminal or civil penalties;
53	53	permitting State Commissio ner of Health to perform
54	54	certain acts; requiring clinical trials to comply
55	55	with certain standards; providing termination date;
56	56	requiring certain approval for contin uation of
57	57	clinical trials; requ iring submission of certain
58	58	report; specifying contents of re port; authorizing
59	59	Commissioner to disclose certain data; directing
60	60	promulgation of rules by certain entities; providing
61	61	for codification; and providing an effective date.
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66	66	BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
67	67	SECTION 1. NEW LAW A new section of law to be codified
68	68	in the Oklahoma Statutes as Section 2-821 of Title 63, unless there
69	69	is created a duplication in numberin g, reads as follows:
70	70	A. As used in this section:
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97	97	1. "Academic medical center " means a medical school and its
98	98	affiliated teaching hospitals and clinics in this state that:
99	99	a. operate a medical residency program for physicians,
100	100	and
101	101	b. conduct research that is overseen by the United States
102	102	Department of Health and Human Services and involves
103	103	human subjects;
104	104	2. "Approved source" means a provider approved by the United
105	105	States Food and Drug Administration (FDA) which produces psilocybin
106	106	that:
107	107	a. has been manufactured and tested in a facility
108	108	approved or certified by the FDA or similar national
109	109	regulatory agency in another country which has been
110	110	approved by the FDA, and
111	111	b. has been tested on animals to demonstrate preliminary
112	112	effectiveness and to ensure that it is safe to
113	113	administer to humans;
114	114	3. "Physician" means a doctor of medicine or doctor of
115	115	osteopathic medicine licensed by the State Board of Medical
116	116	Licensure and Supervision or th e State Board of Osteopathic
117	117	Examiners;
118	118	4. "Psilocybin" means a hallucinogenic chemical compound
119	119	obtained from certain types of fresh and dried mushrooms ; and
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146	146	5. "Qualifying patient" means any person eighteen (18) years of
147	147	age or older who is a veteran of the United States Armed Forces o r
148	148	the Oklahoma National Guard who suffers from major depressive
149	149	disorder, severe depression, or any other form of depression or
150	150	anxiety that is not adequately treated by traditional medical
151	151	therapies.
152	152	B. A statewide investigational new drug application may be
153	153	established in this state, if approved by the FDA, to conduct
154	154	clinical trials using psilocybin on qualifying patients .
155	155	C. Any physician licensed by the State Board of Medical
156	156	Licensure and Supervision or the State Board of Osteopathic
157	157	Examiners, practicing in this state, and treating qualifying
158	158	patients may serve as the principal investigator for such clinical
159	159	trials if such physici an:
160	160	1. Applies to and is approved by the FDA as the principal
161	161	investigator in a statewide investigational new drug application;
162	162	2. Receives a license from the Uni ted States Drug Enforcement
163	163	Administration; and
164	164	3. Receives a registration from the Oklahom a State Bureau of
165	165	Narcotics and Dangerous Drugs Control.
166	166	D. Such physician, acting as principal investiga tor, may
167	167	include subinvestigators who are also board certi fied, practice in
168	168	an academic medical center in this state, and treat qualifying
169	169	patients. Subinvestigators shall comply with the licensing
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196	196	requirement provided in paragraphs 2 and 3 of subsection C of this
197	197	section.
198	198	E. The principal investigator and all subinvestigators shall
199	199	adhere to the rules and regulations established by the relevant
200	200	institutional review board for each participating academic medical
201	201	center and by the FDA, the United States Drug Enforcement
202	202	Administration, the Oklahoma State Bureau of Narcotics and Dangerous
203	203	Drugs Control, and the National Institu te on Drug Abuse.
204	204	F. Nothing in this section shall be cons trued to prohibit a
205	205	physician licensed in Oklahoma from applying for Investigational New
206	206	Drug authorization from the FDA.
207	207	G. The Oklahoma State Bureau of N arcotics and Dangerous Drugs
208	208	Control shall have the authority to inspect and test samples of
209	209	psilocybin used in this state pursuant to the provisions of this
210	210	section.
211	211	H. Clinical trials conducted pursuant to a statewide
212	212	Investigational New Drug application established pursuant to the
213	213	provisions of this section shall only utilize psilocybin which is:
214	214	1. From an approved source; a nd
215	215	2. Approved by the FDA to be used for treatment of a condition
216	216	specified in an Investigational New Drug application.
217	217	I. The principal investigator and any subinvestigator may
218	218	receive psilocybin directly from an approved source or authorized
219	219	distributor for an approved source for use in the clinical trials.
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246	246	J. A person acting in complia nce with the provisions of this
247	247	section shall not be subject to arrest, prosecution, or any civil or
248	248	administrative penalty, including , but not limited to, a civil
249	249	penalty or disciplinary action by a professi onal licensing board, or
250	250	be denied any right or privilege, for the use, prescription,
251	251	administration, possession, manufacture, or distribution of medical
252	252	psilocybin.
253	253	K. The State Commissioner of Health shall have the authority to
254	254	approve physicians conducting clinical trials performed pursuant to
255	255	the provisions of this section. In the event of a substantial
256	256	violation of this section, the Commissioner shall pro vide written
257	257	notice to the Oklahoma State Bureau of Narcotics and Dangerous Drugs
258	258	Control and the Governor. The Governor, upon receipt of a notice
259	259	from the Commissioner, shall have the authority to terminate the
260	260	operations of a clinical trial found to be in violation of any
261	261	provision of this section.
262	262	L. The clinical trials and related research authorized by this
263	263	section shall adhere to the highest standards of acad emic research
264	264	including, but not limited to, peer review of research conducted
265	265	pursuant to this section.
266	266	M. The State Commissioner of Health shall submit a report to
267	267	the Speaker of the Oklahoma House of Representatives and the
268	268	President Pro Tempore of the Oklahoma State Senate on or before
269	269	December 31, 2023. The report shall include a summary o f findings
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296	296	from clinical trials authorized by this section. The Commissioner
297	297	shall, upon request by the Speaker or President Pro Tempore, make
298	298	available any data, excluding individual health records, relating to
299	299	clinical trials authorized by this section.
300	300	N. The Oklahoma State Bureau of Narcotics and Dangerous Drugs
301	301	Control, the Oklahoma State Department of Health, and the Oklahoma
302	302	State Regents for Higher Educatio n shall promulgate rules to
303	303	implement the provisions of this section.
304	304	SECTION 2. This act shall become effective November 1, 2022.
305	305
306	306	58-2-8946 EK 12/28/21

Oklahoma 2022 Regular Session

Oklahoma House Bill HB3174 Compare Versions