See other bills
under the
same topic
PRINTER'S NO. 2260
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
1959
Session of
2021
INTRODUCED BY PENNYCUICK, O'MARA, ISAACSON, T. DAVIS,
SCHLOSSBERG, HENNESSEY, LEWIS DELROSSO, GUENST, POLINCHOCK,
DOWLING, HAMM, SANCHEZ, SAPPEY, SIMS, O'NEAL, SHUSTERMAN,
BOBACK, N. NELSON, BERNSTINE, E. NELSON AND McNEILL,
OCTOBER 12, 2021
REFERRED TO COMMITTEE ON HEALTH, OCTOBER 12, 2021
AN ACT
Providing for research and clinical studies of psilocybin, for
duties of Department of Health, for duties of institutional
review boards, for duties of authorized psilocybin
manufacturers, for duties of approved investigators and for
reports.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Short title.
This act shall be known and may be cited as the Public Health
Benefits of Psilocybin Act.
Section 2. Declaration of purpose.
The General Assembly finds and declares as follows:
(1) Our nation is experiencing an unprecedented mental
health crisis.
(2) In 2021, more than 47,000,000 Americans were
suffering from a mental illness, including more than
1,800,000 adults in this Commonwealth, which represents 18%
of this Commonwealth's adult population.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
(3) Of the 1,800,000 adults in this Commonwealth who
suffer from a mental illness, more than 727,000 suffered from
a substance use disorder and more than 416,000 suffered from
serious thoughts of suicide.
(4) For veterans in the United States, the nationwide
suicide rate is one and a half times greater than
nonveterans.
(5) In the United States, 22 veterans die by suicide
each day.
(6) This Commonwealth ranks amongst the worst states in
the nation in treating mental health conditions with
approximately 480,000 adults in this Commonwealth reporting
an unmet need for their mental health conditions in 2021.
(7) Common barriers to entry for mental health treatment
include the lack of adequate health insurance, shortfalls in
psychiatrists and other mental health professionals, lack of
available treatment types and insufficient finances to cover
health care costs.
(8) The Commonwealth has a history of providing
insufficient funding for mental health care, despite the
continuing escalation of the mental health crisis, which has
now been exacerbated by the COVID-19 pandemic.
(9) While the full extent of the mental health
consequences of the COVID-19 pandemic are not yet fully
understood, a study conducted by Dartmouth University found
that since the onset of the pandemic, rates of depression and
anxiety have soared amongst college-age adults.
(10) Similarly, the United States Department of Health
and Human Services Centers for Disease Control and Prevention
has noted increases in the number of adults seeking mental
20210HB1959PN2260 - 2 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
health care, dealing with anxiety and experiencing symptoms
of depressive episodes.
(11) Consequently, this Commonwealth is in desperate
need of innovative and cost-effective mental health treatment
to combat this significant public health crisis.
(12) A growing body of research suggests that
psilocybin, administered in a controlled setting, may be the
most effective tool at our disposal to combat this public
health crisis.
(13) Studies conducted by world-renowned medical
institutions indicate that psilocybin has shown efficacy,
tolerability and safety in the treatment of mental health
conditions, including, but not limited to, addiction,
depression, anxiety disorders and end-of-life psychological
distress.
(14) The United States Food and Drug Administration,
based on the success of the studies on the efficacy of
psilocybin, has granted a "breakthrough therapy" designation
for use of psilocybin to treat depression.
(15) Numerous jurisdictions in the United States have
reformed their laws to decriminalize or further research the
full scope of the public health benefits of psilocybin.
(16) It is the duty of the Department of Health to
protect the health of the people of this Commonwealth and to
determine and employ the most efficient and practical means
for the prevention and suppression of disease.
(17) This Commonwealth, including this Commonwealth's
substantial veteran community, will benefit from establishing
a psilocybin regulatory system to combat the worsening mental
health crisis.
20210HB1959PN2260 - 3 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
(18) Additional research is required to determine the
efficacy of psilocybin and how to maximize its public health
benefits at the lowest cost with the goal of making the
treatment broadly available if clinical studies prove
successful.
(19) Achieving the optimal public health benefit of
psilocybin requires the Commonwealth to invest in and
facilitate research using naturally grown psilocybin
mushrooms, which would be infeasible if conducted through
private funding.
(20) Our federalist system of government allows states
to experiment and compete in the marketplace of ideas to
achieve the most efficient and practical solutions to the
problems of constituents.
(21) This act provides a framework for research in this
Commonwealth to discover innovative methods to optimize the
public health benefits of psilocybin.
Section 3. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Approved investigator." A medical school, medical research
institute, institution of higher education or medical center in
this Commonwealth that provides medical care to veterans or
community clinics and has a qualified and appropriate lead
investigator for the purpose of conducting clinical studies
under this act.
"Authorized psilocybin manufacturer." An entity approved by
the department to plant, grow and cultivate natural psilocybin
mushrooms solely for use in clinical studies conducted under
20210HB1959PN2260 - 4 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
this act.
"Department." The Department of Health of the Commonwealth.
"Institutional review board." An appropriately constituted
group that has been established by the department to review and
monitor biomedical research involving human subjects under
section 5(a)(1).
"Lead investigator." An individual who meets all of the
following criteria:
(1) The individual conducts a clinical study of
psilocybin under this act, including administering psilocybin
or managing related therapeutic protocols, or in the event of
a clinical study conducted by a group of individuals, is the
manager of the group of individuals for the clinical study.
(2) The individual has the association and approval of
an institutional review board to conduct a clinical study of
psilocybin under this act.
"Psilocybin." Psilocybin and other compounds that cause
nonordinary states of consciousness via serotonin 2A receptor
agonism.
"Psilocybin-assisted therapy." The use of a therapeutic
protocol involving one or more therapy sessions in which the
research subject who receives therapy does so after ingesting
psilocybin.
Section 4. Research and clinical studies of psilocybin.
(a) Evaluation.--The department shall evaluate and determine
the efficacy and cost-benefit optimization of psilocybin and
psilocybin-assisted therapy in the treatment of mental health
conditions and traumatic brain injury as conducted in clinical
studies by approved investigators. The department's evaluation
under this subsection shall include consideration for individual
20210HB1959PN2260 - 5 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
health outcomes and public health outcomes, including methods to
reduce cost and increase scalability of treatment.
(b) Clinical studies.--
(1) An approved investigator may conduct a clinical
study of psilocybin under this act for any of the following
conditions:
(i) Post-traumatic stress disorders.
(ii) Depression.
(iii) Anxiety.
(iv) Suicidal ideation.
(v) Eating disorders.
(vi) Bipolar disorders.
(vii) Chronic pain.
(viii) Migraines.
(ix) Substance use disorders.
(x) Traumatic brain injury.
(2) An approved investigator shall use a therapeutic
dose of psilocybin for each participant in a clinical study
of psilocybin conducted under this act.
(3) An approved investigator may include a control group
for any of the following in a clinical study of psilocybin
conducted under this act:
(i) Therapeutic dose levels.
(ii) A comparison of naturally grown psilocybin
mushrooms and synthetic psilocybin.
(iii) Therapeutic protocols.
(iv) Any other similar comparative purpose to
determine the efficacy and cost-benefit maximization of
psilocybin to treat mental health.
(4) A clinical study of psilocybin conducted under this
20210HB1959PN2260 - 6 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
act may include any of the following:
(i) A participant who is deemed healthy by a lead
investigator and is accompanied by a family member who
suffers from a condition specified under paragraph (1).
(ii) The administration of psilocybin in a
supervised group setting. If the administration of
psilocybin involves a participant under subparagraph (i),
the participant shall be accompanied by a family member
who suffers from a condition specified under paragraph
(1).
(iii) The administration of psilocybin in a
controlled, outdoor setting.
Section 5. Duties of department.
(a) Duties.--The department shall have the following duties:
(1) Establish an institutional review board for the
purposes specified under section 6.
(2) When allocating funds for clinical studies of
psilocybin conducted under this act, prioritize the approval
of clinical studies specific to the treatment of veterans and
retired first responders and their family members.
(3) Collect data from clinical studies of psilocybin
conducted under this act that seek to determine the efficacy
and cost-benefit optimization of psilocybin and psilocybin-
assisted therapy in accordance with the purposes of this act.
(4) Identify and authorize two or more qualified
entities to plant, grow and cultivate natural psilocybin
mushroom product solely for use in the clinical studies of
psilocybin conducted under this act.
(5) Adopt standards as the department deems necessary
for an entity to be qualified for consideration as an
20210HB1959PN2260 - 7 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
authorized psilocybin manufacturer.
(6) Adopt standards as the department deems necessary
for testing and confirming the quality and dosages of
psilocybin certified by an authorized psilocybin
manufacturer.
(7) Authorize as many qualified entities as deemed
necessary to carry out the clinical studies of psilocybin
conducted under this act.
(8) Adopt standards and testing procedures for ensuring
consistent quality and dosages of natural psilocybin
mushrooms for clinical studies of psilocybin conducted under
this act.
(b) Preferences.--The department may give preference for the
funding of clinical studies of psilocybin that utilize specific
psilocybin-assisted therapy protocols and psilocybin dosages if
the department reasonably determines that the clinical studies
would add to the available research literature that is relevant
for the purposes of this act.
(c) Coordination.--The department may coordinate with
clinicians conducting studies of psilocybin in other states to
collect unpublished data and results.
Section 6. Duties of institutional review boards.
(a) Duties.--An institutional review board shall have the
following duties:
(1) Oversee proposed clinical studies of psilocybin
conducted under this act.
(2) Assist lead investigators at sites lacking formal
institutional review board oversight.
(3) Protect the rights, safety and welfare of human
subjects under this act.
20210HB1959PN2260 - 8 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
(b) Psilocybin research.--An institutional review board may
approve, require modifications in order to secure approval or
disapprove psilocybin research.
Section 7. Duties of authorized psilocybin manufacturers.
An authorized psilocybin manufacturer shall certify, in
writing, to the department and an approved investigator that the
authorized psilocybin manufacturer meets all of the following
criteria:
(1) The authorized psilocybin manufacturer has complied
with the department's required standards and testing
procedures to ensure consistent quality and dosages.
(2) The authorized psilocybin manufacturer's psilocybin
mushrooms meet the required specifications for each clinical
study of psilocybin.
Section 8. Duties of approved investigators.
(a) Contracts.--An approved investigator shall contract
directly with an authorized psilocybin manufacturer for the
purchase of natural psilocybin mushrooms in accordance with the
specifications requested by the lead investigator of each
clinical study of psilocybin.
(b) Synthesized psilocybin.--An approved investigator may
acquire synthesized psilocybin for comparative research with
natural psilocybin mushrooms by contracting directly with the
manufacturer of the synthesized psilocybin. An authorized
psilocybin manufacturer may not provide synthesized psilocybin
under this subsection.
Section 9. Reports.
(a) Quarterly reports.--The department shall prepare and
submit quarterly reports on the progress of the clinical studies
of psilocybin conducted under this act to the Governor, the
20210HB1959PN2260 - 9 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
Lieutenant Governor and each member of the General Assembly.
(b) Final reports.--No later than January 1, 2025, the
department shall prepare and submit a final report to the
Governor, the Lieutenant Governor and each member of the General
Assembly. The final report shall contain all of the following:
(1) The results of the clinical studies of psilocybin
conducted under this act.
(2) An analysis of the current state of available
research related to psilocybin and similar compounds.
(3) An overview of current Federal laws related to
psilocybin and similar compounds.
(4) An overview of laws in other states related to
psilocybin and similar compounds, including an analysis of
the successes and challenges of the laws in other states with
a particular focus on the regulatory framework for research
or the implementation of psilocybin-assisted therapy
developed in other states.
(5) An overview of proposed Federal, State, local and
other jurisdictional laws or ordinances, including proposed
laws or ordinances outside of the United States, related to
psilocybin and similar compounds.
(6) Recommendations for legislative actions or other
actions to enact a framework for further research of
psilocybin and similar compounds, including a consideration
of systems adopted by other states and the medical marijuana
research framework already established in this Commonwealth.
(7) Recommendations for legislative actions or other
actions for the implementation of a regulatory system
governing the use of psilocybin and psilocybin-assisted
therapy with the goal of minimizing cost and maximizing the
20210HB1959PN2260 - 10 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
public health benefit of treatment.
(c) Confidentiality.--The department shall ensure protected
health information collected during a clinical study of
psilocybin conducted under this act or for a report under this
section remains confidential and does not personally identify an
individual.
Section 10. Effective date.
This act shall take effect in 60 days.
20210HB1959PN2260 - 11 -
1
2
3
4
5
6
7
8