Add Art 27-G §§2788 - 2794, Art 33-AA §§3397-j - 3397-l, amd §3350, Pub Health L
Establishes the psychedelic research institute and the psychedelic substances therapeutic research program which shall study and provide recommendations regarding the use of psychedelic substances in the treatment of addictive disorders, depression, post-traumatic stress disorder, end-of-life anxiety and other pertinent outcomes.
STATE OF NEW YORK
2021-2022 Regular Sessions
June 1, 2021
Introduced by M. of A. L. ROSENTHAL -- read once and referred to the
Committee on Health
AN ACT to amend the public health law, in relation to establishing the
psychedelic research institute and the psychedelic substances thera-
peutic research program
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. The public health law is amended by adding a new article
2 27-G to read as follows:
3 ARTICLE 27-G
4 PSYCHEDELIC RESEARCH INSTITUTE
5 Section 2788. Legislative findings.
6 2789. Definitions.
7 2790. The institute for therapeutic psychedelics research.
8 2791. Powers and duties.
9 2792. Research council.
10 2793. Advisory council.
11 2794. Reports by the commissioner.
12 § 2788. Legislative findings. The legislature finds that recent
13 research provides a growing body of evidence that 1. the use of psyche-
14 delics such as ibogaine, LSD, psilocybin and certain other psychedelic
15 drugs in certain settings may provide a treatment for people struggling
16 with a substance use disorder, including methamphetamine, opioids, and
17 other addictive substances; 2. 3, 4-methylenedioxymethamphetamine (MDMA)
18 may be efficacious in treatment of post-traumatic stress disorder (PTSD)
19 and alcoholism; 3. psilocybin is a breakthrough therapy for severe
20 depression and nicotine addiction; and 4. other psychedelic substances
21 also may be efficacious in treatment of other illnesses and maladies. It
22 is for the purpose of facilitating clinical programs for such research
23 and investigation into the safety and efficacy of psychedelic substances
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
 is old law to be omitted.
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1 for treatment of human illnesses and maladies that the psychedelic
2 substances therapeutic research act is hereby enacted.
3 § 2789. Definitions. For purposes of this article, the following terms
4 shall have the following meanings:
5 1. "Psychedelic substance" means any substance listed in paragraph (d)
6 of schedule I of section thirty-three hundred six of this chapter.
7 2. "Principal investigator" means an individual who actually conducts
8 a clinical investigation, i.e., under whose immediate direction the test
9 article is administered or dispensed to, or used involving, a subject,
10 or, in the event of an investigation conducted by a team of individuals,
11 is the responsible leader of that team.
12 3. "Hospital" shall have the same meaning as defined pursuant to
13 section twenty-eight hundred one of this chapter.
14 4. "Clinic" shall mean a site where a licensed or otherwise recognized
15 practitioner or group provides care to patients and/or individuals seek-
16 ing therapeutic interventions using psychedelic substances as listed
18 5. "Internal review board" or "IRB" means an appropriately constituted
19 group that has been formally designated to review and monitor biomedical
20 research involving human subjects. In accordance with food and drug
21 administration regulations, an IRB shall have the authority to approve,
22 require modifications in (to secure approval), or disapprove research.
23 IRB group review shall serve an important role in the protection of the
24 rights, safety and welfare of human research subjects.
25 § 2790. The institute for therapeutic psychedelics research. 1. There
26 is hereby established within the department the public institute for
27 therapeutic psychedelics research (ITPR). The institute shall have the
28 central responsibility for administering the provisions of this article
29 and otherwise coordinating the state's policies with respect to the use
30 of psychedelic substances in treatment of substance use disorders,
31 depression, post-traumatic stress disorder, end-of-life anxiety and
32 other conditions.
33 2. The commissioner shall appoint a director of the institute and may
34 assign such personnel within the amounts appropriated as is necessary to
35 carry out the provisions of this article.
36 3. The state of New York shall designate such spaces within existing
37 state-owned or operated facilities or buildings, or in conjunction with
38 local departments of health, to establish a headquarters and, as appro-
39 priate clinics to conduct clinical trials of psychedelic substances for
40 appropriate clinical outcomes, including, but not limited to, substance
41 use disorders, depression, end-of-life anxiety and post-traumatic stress
43 § 2791. Powers and duties. 1. The institute shall have the following
44 powers and duties:
45 (a) to coordinate, develop and promote clinical programs and trials
46 with appropriate methodologies to study and investigate the safety and
47 efficacy of psychedelics for various outcomes, and assist in the coordi-
48 nation of extramural clinical studies, including as needed, access to
49 psychedelic agents and other programmatic needs;
50 (b) to develop and promote programs of professional education and
51 training and improvements in instrumentation as necessary adjuncts to
52 such scientific investigations;
53 (c) to form an institutional review board to provide oversight in
54 proposed clinical trials of psychedelic compounds, particularly to
55 assist principal investigators at sites lacking formal institutional
56 review board oversight;
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1 (d) to develop and maintain a clearinghouse within the department for
2 information collected on the safety and efficacy of psychedelic
3 substances as well as to provide a registry for all outcomes of clinical
4 trials and studies, including a catalog of the existing medical litera-
5 ture and the results of existing epidemiological studies;
6 (e) to develop and promote an outreach campaign directed toward people
7 struggling with substance use disorder, depression, post-traumatic
8 stress disorder, anxiety, alcoholism and nicotine addiction to promote
9 the availability of psychedelic compounds as a treatment through clin-
10 ical programs established hereunder as well as any clinical research and
11 investigative programs that studies and investigates the safety and
12 efficacy of psychedelic substances; and
13 (f) to promote the availability of any other supportive services for
14 people struggling with substance use disorder, depression, post-traumat-
15 ic stress disorder, anxiety, alcoholism and nicotine addiction as well
16 as long term outcomes after treatment for such conditions or other
17 aforementioned indications.
18 2. Personal data in any investigations, reports and information relat-
19 ing to the provisions of this article shall be kept confidential and
20 anonymous, shall be afforded all of the protections provided by the
21 provisions of paragraph (j) of subdivision one of section two hundred
22 six of this chapter, and are hereby made subject to part two of title
23 forty-two of the Code of Federal Regulations. The institute may however,
24 from time to time, publish reports of such scientific investigations in
25 such a manner as to assure that the identities of the individuals
26 concerned cannot be ascertained.
27 § 2792. Research council. 1. There shall be established within IPTR a
28 research council composed of fifteen members; four members to be
29 appointed by the temporary president of the senate, one member to be
30 appointed by the minority leader of the senate, four members to be
31 appointed by the speaker of the assembly, one member to be appointed by
32 the minority leader of the assembly and five members to be appointed by
33 the commissioner. The members shall be representative of recognized
34 centers engaged in the scientific investigation of substance abuse
35 disorders and/or the use of psychedelics in treatment of pertinent
37 2. The research council shall be responsible for making recommenda-
38 tions to the institute for the purpose of carrying out the provisions of
39 paragraphs (a) and (b) of subdivision one of section twenty-seven
40 hundred ninety-one of this article, as well as appointing members of the
41 internal review board as provided for in paragraph (c) of subdivision
42 one of section twenty-seven hundred ninety-one of this article.
43 3. The council shall meet at least six times a year. Special meetings
44 may be called by the chairperson and shall be called by him or her at
45 the request of the commissioner.
46 4. The members of the council shall receive no compensation for their
47 services, but shall be allowed their actual and necessary expenses
48 incurred in the performance of their duties hereunder.
49 § 2793. Advisory council. 1. There shall be established within IPTR an
50 advisory council composed of thirteen members who shall be appointed in
51 the following manner: three shall be appointed by the temporary presi-
52 dent of the senate and one by the minority leader of the senate; three
53 shall be appointed by the speaker of the assembly and one by the minori-
54 ty leader of the assembly; and five shall be appointed by the governor.
55 The governor shall designate the chairperson of the advisory council.
56 The members of the council shall be representative of the public, educa-
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1 tional and medical institutions, local health departments, and nonprofit
2 organizations, including organizations and individuals qualified through
3 degree and/or experience presently providing psychedelic substances as a
4 treatment modality for people struggling with a substance use disorder,
5 depression, post-traumatic stress disorder, anxiety, alcoholism and
6 nicotine addiction.
7 2. The advisory council shall be responsible for advising the commis-
8 sioner with respect to the implementation of this article and shall make
9 recommendations to the institute for the purpose of carrying out the
10 provisions of paragraphs (d), (e), and (f) of subdivision one of section
11 twenty-seven hundred ninety-one of this article.
12 3. The advisory council shall include at least four members of
13 affected communities, provisions for a stipend, travel or other expenses
14 to be established to provide insight and support from the community
15 perspective in the development of clinical trial protocols.
16 4. The council shall meet at least four times a year. Special meetings
17 may be called by the chairperson and shall be called by him or her at
18 the request of the commissioner.
19 § 2794. Reports by the commissioner. The institute shall make an
20 initial preliminary report to the governor and the legislature of its
21 findings, conclusions, and recommendations not later than December
22 first, two thousand twenty-one, a second preliminary report of its find-
23 ings, conclusions, and recommendations not later than December first,
24 two thousand twenty-two, and a report of its findings, conclusions, and
25 recommendations with regard to the progress made in developing, promot-
26 ing and completing clinical evaluations not later than December first,
27 two thousand twenty-three, and shall submit with its reports such legis-
28 lative proposals as it deems necessary to implement its recommendations.
29 § 2. The public health law is amended by adding a new article 33-AA to
30 read as follows:
31 ARTICLE 33-AA
32 PSYCHEDELIC SUBSTANCES THERAPEUTIC RESEARCH ACT
33 Section 3397-j. Psychedelic substances therapeutic research program
34 established; participation.
35 3397-k. State patient qualification board; composition; powers
36 and duties.
37 3397-l. Psychedelic substances research program; cultivation and
39 § 3397-j. Psychedelic substances therapeutic research program estab-
40 lished; participation. 1. The psychedelic substances therapeutic
41 research program is hereby established in the department. The commis-
42 sioner shall promulgate rules and regulations necessary for the proper
43 administration of the psychedelic substances therapeutic research
44 program. In such promulgation, the commissioner shall take into consid-
45 eration the reports of the psychedelics research institute and pertinent
46 rules and regulations of the food and drug administration.
47 2. Participation in the psychedelics substances therapeutic research
48 program shall be limited to persons eligible for participation by the
49 internal review board (IRB)-approved inclusion and exclusion criteria of
50 proposed clinical study. Outcome-directed clinical trials and evalu-
51 ations may include persons addicted to opiates or methamphetamine,
52 persons suffering from post-traumatic stress disorder (PTSD), or persons
53 suffering from severe depression, as appropriate to the trial design
54 registered with the public institute for therapeutic psychedelics
55 research (ITPR) and the protocols specified in 42 CFR 11.
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1 3. Where pertinent, participants in ITPR studies or evaluations should
2 receive the current standard of care. Stakeholder community members will
3 be consulted regarding proposed clinical trials for their or other
4 studies, case series or other appropriate methodologies for evaluating
5 the efficacy of psychedelic substances.
6 4. The commissioner, on behalf of the department, shall apply to the
7 food and drug administration (FDA) for an investigational new drug
8 permit for any of the psychedelic agents listed in section twenty-seven
9 hundred eighty-eight of this chapter, including but not limited to
10 ibogaine, psilocybin, LSD, cannabis, MDMA, DMT and other such agents
11 within ninety days after the effective date of this section. The commis-
12 sioner, on behalf of the department, may apply to the FDA for an inves-
13 tigational new drug (IND) permit for any other psychedelic substance as
14 the commissioner deems appropriate. The commissioner shall continue to
15 fulfill all of his or her duties hereunder unless and until this article
16 is repealed.
17 § 3397-k. State patient qualification board; composition; powers and
18 duties. 1. The commissioner shall appoint a state patient qualification
19 review board of no less than three nor more than five members. The state
20 patient qualification review board shall be comprised of:
21 (a) a physician licensed to practice medicine in New York state and
22 certified by the American board of internal medicine;
23 (b) a physician licensed to practice medicine in New York state and
24 certified in psychiatry by the American board of psychiatry and neurolo-
25 gy; and
26 (c) any other members that the commissioner may deem necessary,
27 including individuals who may act in their capacity as a principal
28 investigator as defined pursuant to section twenty-seven hundred eight-
29 y-nine of this chapter.
30 2. Members of such board shall be appointed for three-year terms,
31 except that the terms of those first appointed shall be arranged so that
32 as nearly as possible an equal number shall terminate annually. A vacan-
33 cy occurring during a term shall be filled through an appointment by the
34 commissioner for the unexpired term. The commissioner shall designate
35 the chairperson of the board. Any member may be removed from the board
36 at the discretion of the commissioner.
37 3. Each member of the board shall receive up to two hundred fifty
38 dollars as prescribed by the commissioner for each day devoted to board
39 work, not to exceed seventy-five hundred dollars in any one year and
40 shall be reimbursed for necessary expenses.
41 4. Any hospital may establish a hospital patient qualification review
42 committee subject to the rules and regulations promulgated by the
43 commissioner. A hospital may designate a hospital human research review
44 committee as set forth in section twenty-four hundred forty-four of this
45 chapter to serve as a hospital patient qualification review committee.
46 5. The hospital patient qualification review committee shall review
47 each recommendation and shall submit approved patient applications to
48 the state patient qualification review board.
49 6. The state patient qualification review board shall review all prin-
50 cipal investigator applicants for the psychedelic substances therapeutic
51 research program and certify or refuse to certify their participation in
52 such program.
53 7. The state patient qualification review board may delegate to a
54 hospital patient qualification review committee the authority to approve
55 or disapprove a patient's participation in such program.
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1 8. The hospital human research review committee shall review each
2 human research project proposed hereunder and shall certify to the
3 hospital patient qualification review committee that such project meets
4 the requirements of this article and article twenty-four-A of this chap-
6 § 3397-l. Psychedelic substances research program; cultivation and
7 distribution. 1. The commissioner shall obtain psychedelic substances
8 through whatever means the commissioner deems most appropriate, consist-
9 ent with regulations promulgated by the food and drug administration and
10 pursuant to the provisions of this article.
11 2. If, within a reasonable time, the commissioner is unable to obtain
12 psychedelic substances pursuant to subdivision one of this section, the
13 commissioner shall conduct an inventory of available sources of such
14 substances in compliance with certified good manufacturing practices
15 research grade standards pursuant to 21 CFR 211 and 21 CFR 210.1(a).
16 Such inventory shall be for the purpose of determining the feasibility
17 of obtaining controlled substances for use in the program. Upon
18 conducting said inventory, the commissioner shall contract with the
19 available source and obtain drug enforcement administration (DEA)
20 licenses for the receipt of controlled substances.
21 3. If, within a reasonable time, the commissioner is unable to obtain
22 psychedelic substances pursuant to subdivision one of this section, and
23 notwithstanding the identification of an available source of such drugs
24 in compliance with certified good manufacturing practices and FDA
25 research grade standards, the commissioner is unable to obtain such
26 drugs due to a refusal or failure of the DEA to issue the necessary
27 licenses for the receipt of controlled substances, the commissioner
28 shall contract with the available source and obtain the drugs without a
29 DEA license.
30 4. The commissioner shall cause such psychedelic substances to be
31 transferred to the clinics affiliated with the institute established
32 pursuant to article twenty-seven-G of this chapter or to such research
33 institute or hospital itself for distribution to certified patients
34 pursuant to this article.
35 § 3. Section 3350 of the public health law, as added by chapter 878 of
36 the laws of 1972, is amended to read as follows:
37 § 3350. Dispensing prohibition. Controlled substances may not be
38 prescribed for, or administered or dispensed to [addicts] people strug-
39 gling with substance use disorder or habitual users of controlled
40 substances, except as provided by this title or title III of this arti-
41 cle or article thirty-three-AA of this chapter.
42 § 4. This act shall take effect on the one hundred eightieth day after
43 it shall have become a law.