A07928 Summary:

BILL NOA07928
 
SAME ASNo Same As
 
SPONSORRosenthal L
 
COSPNSR
 
MLTSPNSR
 
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.
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A07928 Actions:

BILL NOA07928
 
06/01/2021referred to health
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A07928 Memo:

NEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)
 
BILL NUMBER: A7928
 
SPONSOR: Rosenthal L
  TITLE OF BILL: An act to amend the public health law, in relation to establishing the psychedelic research institute and the psychedelic substances therapeu- tic research program   PURPOSE: To create a psychedelics research institute to study the use of psyche- delics for treatment of substance use disorder, depression, anxiety, post-traumatic stress disorder and other disorders.   SUMMARY OF SPECIFIC PROVISIONS: Section one amends the public health law by adding a new article 27-G. Section two amends the public health law by adding a new article 33-AA. Section three amends section 3350 of the public health law. Section four sets forth the effective date.   JUSTIFICATION: There is growing evidence to suggest that psychedelics, including psilo- cybin, can be a useful tool in treating symptoms of depression, anxiety, post-traumatic stress disorder and to help individuals recover from a substance use disorder. Psychedelics provide a host of benefits without the same risk of overdose or dependency that other medications may provide. In November 2020, Oregon became the first state to permit the use of psychedelics for therapeutic purposes and many localities have enacted or are considering similar legislation. This bill would provide New York State the opportunity to research the use of psychedelics and the many benefits they can provide.   LEGISLATIVE HISTORY: New bill.   FISCAL IMPLICATIONS: Undetermined.   EFFECTIVE DATE: This act shall take effect immediately.
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A07928 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                          7928
 
                               2021-2022 Regular Sessions
 
                   IN ASSEMBLY
 
                                      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.
                                                                   LBD11370-02-1

        A. 7928                             2
 
     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
    17  herein.
    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
    42  disorder.
    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;

        A. 7928                             3
 
     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
    36  outcomes.
    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-

        A. 7928                             4
 
     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
    38                    distribution.
    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.

        A. 7928                             5

     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.

        A. 7928                             6
 
     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-
     5  ter.
     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.
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