My presentation on psychedelic law to attorneys in the New York City Council

Following is most of the outline for the presentation I gave to staff attorneys yesterday in a Continuing Legal Education class.

It includes much of the material that appears in the pdf included in my post from May but it includes in addition comments on the Colorado, New Jersey, and New York bills.

One of these days I’m going to get around to figuring out how to make use of the intricate formatting and other tools offered by WordPress. In the meantime I place before you some no-frills, minimally/inconsistently-formatted text. For better or worse (probably worse), I’ve always been a content over form kinda guy.

Course description

In May 2019 Denver voters voted to decriminalize the psychedelic substance psilocybin, launching a wave of advocacy reform around the United States at the local, state, and federal levels. Psychedelic policy reform is moving faster than cannabis ever has. The purpose of this class is to give a broad overview of the legal history of psychedelic substances in the United States concluding with general comments about policy reform at the local level in the context of state-level legalization efforts, including those in New Jersey and New York. 

Presenter biographical statement:

Noah Potter is a New York City-based attorney and principal of the psychedelic sector consulting firm Legal Market Strategies. As an undergraduate political science student in 1994 he co-founded Cures Not Wars, an early direct action psychedelic policy reform advocacy group.

He is chair emeritus of the New York City Bar Association’s Committee on Drugs and the Law and author of the New Amsterdam Psychedelic Law blog (and an organizer of the New York City Cannabis Parade). In 2018 he assisted the Decriminalize Denver campaign in obtaining board of elections approval of the psilocybin decriminalization ballot initiative, whose passage in 2019 launched a wave of state and local psychedelic law reform around the United States. In 2020 and 2021 he briefed New York State and New York City elected officials on psychedelic policy reforms options. His twenty-two years in commercial litigation and appeals inform his perspective on psychedelic markets. He is a member in good standing of the New York bar.

Table of Contents

I. Introduction

A. Psychedelics present their own unique paradigm
B. Relationship to cannabis
C. Implicated populations
D. Selected specific policy issues

II. What are psychedelics?

A. Terminology
B. History

III. Religious freedom to use psychedelics begins under federal law

IV. The “psychedelic renaissance”

V. Miscellaneous developments/legal issues

1. Right to Try litigation out of Washington State
2. State law action alleging undue influence resulting in part from psychedelic use
3. Intellectual property

VI. State and local level legislative reform

1. The local level
2. State level reform
A. Lead legislative model: Licensed “psychedelic services” system in Oregon
B. Some other models
3. Colorado, New Jersey, and New York
4. Local opt-out in Oregon
5. The report of the Denver Psilocybin Mushroom Policy Review Panel

VII. Options for New York City and questions

PRESENTATION

I. Introduction

Looking at the issue of psychedelic law reform as a question of market models, which means regulatory paradigms

A. Psychedelics present their own unique paradigm

I argue that they are not properly understood within the opioid paradigm, which is the prevailing model of controlled substances regulation since the beginning of the 20th Century (at a time when people didn’t understand what neurotransmitters are). Instead they present their own paradigm. One can think of them as a “new” cognitive technology.

Like cannabis (see comment on terminology below) they don’t fit neatly into one legal/regulatory category.

  • Medicine – FDA-approved drugs

But they are unusual pharmacotherapies in that engage an individual cognitively, not just by reducing symptoms

  • Sacramental/ceremonial use, e.g., as “entheogens”
  • Wellness products
  • “Recreational” substances in commercial retail markets

    B. Relationship to cannabis

The relationship between cannabis and other[1] psychedelics is multi-faceted. There is extensive media messaging that psychedelics, or at least psilocybin, are “the new cannabis,” an extremely problematic over-simplification/error.

At a minimum, as a practical matter, psychedelics are different in that they are moving forward through FDA-approved clinical trials towards federal legalization as “drugs.”

In my assessment, the talking points for psychedelics are significantly different from cannabis: they are not about reducing societal harms of prohibition, providing legal employment opportunities, and/or generating tax revenue. For legislative reform purposes, they primarily are about cost-savings through facilitating access to more effective pharmacotherapies in mental health care, although they also include the civil liberties and access to health care arguments present in cannabis.

There are social equity aspects of psychedelics, but they differ from cannabis: equitable access and culturally-relevant/appropriate treatment which means that there is an acute need for diversity in therapists/“facilitators.”  There are also sustainability issues not present in and different from those in cannabis.

C. Implicated populations

Veterans – the public face of legalization advocacy — PTSD
First responders – PTSD
Substance abuse/alcoholism/nicotine
Geriatric medicine – end of life anxiety
Terminally ill – end of life anxiety
Depression/suicide prevention
Recidivism – for some reason this topic is not being discussed although there are peer-reviewed journal articles suggesting that psychedelic use is associated with reduced rates of recidivism

D. Selected specific policy issues

Psychedelics can induce individual lifestyle change/value system change, which in the aggregate can induce societal changes. See, e.g., the 1960s.

Your standard FDA-approved psychiatric medications don’t do that.

There is minimal risk of physiological harm, except with ibogaine and MDMA in some circumstances

There are the standard incapacity issues – e.g., driving under the influence

However, there is extreme vulnerability, disorientation, and suggestibility of persons undergoing psychedelic experiences, creating a different dynamic for sexual assault by therapists and shamans.

There may be increased dependence on “enlightened” teachers

There may be other risks, types of liability – unknown

Political issues in drug policy reform relationship: there is a tense relationship between all-drug legalization and “psychedelic-specific” legislation.

Within the psychedelic legalization movement, there are intense ideological divides, far fiercer than those in cannabis.

III. What are psychedelics?

A. Terminology

Imprecise designation of various psychoactive substances whose pharmacological action and subjective effects differ: psychedelics colloquially generally refers to lysergic acid diethylamide, psilocybin, DMT, mescaline, ibogaine, and bufotenine.

Generally includes MDMA and ketamine, although both differ in their action and effects from the “classic psychedelics.”

See  21 C.F.R. 1308 (d)

  • (11) MDMA
  • (17) bufotenine
  • (19) DMT
  • (21) ibogaine
  • (22) LSD
  • (23) “Marihuana” A/K/A cannabis
  • (24) mescaline
  • (26) peyote
  • (29) psilocybin
  • (30) psilocyn

and New York Public Health Law § 3306(d)

It has always been difficult to formulate terms to describe them:

Officially still “hallucinogens” in the federal and state controlled substances acts.

“Psychedelic” coined by Dr. Humphry Osmond in 1957; one among many candidates.

From Greek; means approximately “mind-manifesting.”

“Entheogen,” meaning approximately “generating God within” is popular among certain constituencies.

Michael Pollan’s breakthrough 2018 book How to Change Your Mind uses the term “ineffable” to describe a psychedelic experience – inexpressible.

B. History

Examples of use long before and/or outside of Western biomedicine

  • Carvings of mushrooms in North Africa 7000-8000 B.C.E.
  • Eleusinian Mysteries in Ancient Greece
  • Psilocybin mushrooms in Central America and Mexico before arrival of Europeans
  • Iboga in Gabon
  • Ayahuasca in South America
  • Peyote use in Native American Church

    Some allege that they played an important role in many ancient religions.

    Awareness of psychedelics in European and European-derived societies: 
  • Long “amnesia”: association of psychedelic or “dissociative” substances with witchcraft in medieval Europe; suppression by Church
  • Suppression of mushroom use in Mexico by Spanish           
  • 1864 – French become aware of indigenous use of iboga root bark
  • 1887 – identification of mescaline, present in peyote cactus in southwest United States
  • 1943 – synthesis of lysergic acid diethylamide (LSD) by Albert Hofmann in Switzerland; derived from ergot (rye fungus); unintentional discovery of psychedelic effects
  • 1955 – R. Gordon Wasson participates in psychoactive mushroom ceremony in Mexico; Life Magazine publishes his article about the experience; Dr. Hofmann subsequently identifies psilocybin as psychoactive substance

LSD as “wonder drug”

  • Thousands of administrations of psychedelic substances by researchers and physicians in 1950s. “Wonder drug”: academic papers published on LSD
  • Model psychosis, breakthrough therapy – but first a proposed mind control drug/weapon (CIA’s MK-ULTRA program)
  • See https://www.trippingly.net/lsd-studies for a sample of articles in the 1950s and 1960s mainstream media about psychedelics as medicine.

Federal prohibition

  • 1963 – departure of Timothy Leary and Richard Alpert from Harvard University in connection with notoriety of their psychedelic use and experimentation
  •  1965 federal Drug Abuse Control Amendments of 1965 (P.L. 89-75) to the Food, Drug, and Cosmetic Act restricted manufacture, compounding, processing, sale, delivery, or other disposition of “depressants” and “stimulants,” the latter of which included any substance which the Department of Health, Education, and Welfare found to have a potential for abuse “because of its…hallucinogenic effect,” to restricted categories of persons: e.g. pharmaceutical companies, wholesale distributors, physicians and researchers.
  • By late 1960s widespread non-medical use led to backlash against psychedelics and designation as public health threat.
  • 1970 Controlled Substances Act created federal Schedules I-V. 21 U.S.C. 812
  • LSD, psilocybin, DMT, ibogaine, mescaline placed in most restrictive category, Schedule I (alongside cannabis).
  • Research declined precipitously.
  • Last research in humans ended in 1978.
  • Dr. Rick Doblin, in his Ph.D. thesis at the Harvard Kennedy School of Government, describes an unwritten FDA policy of keeping in limbo applications to conduct research into therapeutic uses of psychedelics.

Primary federal statutes and regulators

  • Two federal statutes overlap with regard to psychoactive substances:
  • The Controlled Substances Act Title 21 of the U.S. Code, Chapter 16 (21 U.S.C. 801 et seq.)
  • The Food Drug and Cosmetic Act, Title 21 of the US Code, Chapter 9 (21 U.S.C. 301 et seq)
  • Two administrative agencies, the Drug Enforcement Administration in the Department of Justice, and the Food and Drug Administration in the Department of Health and Human Services
  • Under the CSA, DEA is the lead agency and has authority to place substances in one of five “schedules,” which correspond to varying degrees of criminal penalties. 21 U.S.C. § 811; FDA is limited to making recommendations as to scheduling.
  • All actions associated with the substances in “Schedule I” are subject to criminal penalty unless (a) they are approved for use in research or (b) the DEA issues a waiver.

III. Religious freedom to psychedelics begins under federal law

Native American Church

Enactment of the American Indian Religious Freedom Act in 1978

the use, possession, or transportation of peyote by an Indian for bona fide traditional ceremonial purposes in connection with the practice of a traditional Indian religion is lawful, and shall not be prohibited by the United States or any State. No Indian shall be penalized or discriminated against on the basis of such use, possession or transportation, including, but not limited to, denial of otherwise applicable benefits under public assistance programs.

42 U.S.C. 1996a-(b)(1)

Protects the Native American Church, a syncretic religion established in the 1890s that uses the peyote cactus (prohibited at 21 C.F.R. 1308(d)(26) in ceremonies.  

Peyote prohibition triggers the Religious Freedom Restoration Act

  • In Oregon v. Smith, 494 U.S. 872 (1990), the Oregon Department of Human Resources denied unemployment benefit members to two members of the Native American Church, substance abuse treatment providers, who were discharged for use of peyote.
  • The Court upholds the denial of benefits on the grounds that the Free Exercise Clause does not bar application of a neutral, generally- applicable law to religiously-motivated action.
  • Congress reacts by passing the Religious Freedom Restoration Act. 42 U.S.C. §2000bb–1(b).
  • RFRA prohibits the Federal Government from substantially burdening a person’s exercise of religion, even if the burden results from a rule of general applicability except when the Government can demonstrate that application of the burden to the person (1) furthers a compelling government interest; and (2) is the least restrictive means of furthering that interest.

Selective exemption of ayahuasca from the Controlled Substances Act under RFRA

  • Centro Espirita Beneficente Uniao do Vegetal (UDV) is a Brazil-based syncretic religion that incorporates consumption of ayahuasca, a brew derived from two rainforest plants that contains DMT, which is prohibited at 21 C.F.R. § 1308(d)(19).
  • In Gonzales v. O Centro Espirita Beneficente Uniao do Vegetal, 546 U.S. 418 (2006), U. S. Customs inspectors seized a shipment of ayahuasca to the U.S. branch of the UDV and threatened prosecution. The Court affirmed an order in UDV’s favor enjoining application of the Controlled Substances Act to the UDV’s sacramental use under RFRA.

In 2009 the DEA issued guidelines for petitioning for waivers from application of the Controlled Substances Act based on RFRA. https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-5)(EO-DEA-007)(Version2)RFRA_Guidance_(Final)_11-20-2020.pdf

  • The guidelines provide guidance to persons seeking exemptions from application of the Controlled Substances Act to the party’s activity on the grounds that it “would (1) be a substantial burden on (2) his/her sincere (3) religious exercise.”

The petition should provide detailed information about, among other things:
(1) the nature of the religion {e.g., its history, belief system, structure, practice, membership policies, rituals, holidays, organization, leadership, etc.);
(2) each specific religious practice that involves the manufacture, distribution, dispensing, importation, exportation, use or possession of a controlled substance;
(3) the specific controlled substance that the party wishes to use; and
(4) the amounts, conditions, and locations of its anticipated manufacture, distribution, dispensing, importation, exportation, use or possession.

  • As a result, the DEA, a federal police agency, is in the business of determining what qualifies as a “religion” for the purposes of waiving application of a criminal statute to religious practice.

IV. The “psychedelic renaissance”

Gradual resumption of clinical research beginning in 1990 with DMT.

Current “psychedelic renaissance”: worldwide explosion in research, publication of medical journal articles, coverage in popular media, proliferation of small pharmaceutical companies dedicated to bringing patented psychedelic substances into the market as adjuncts to psychedelic-assisted therapy, millions of investment dollars pouring in – “the new cannabis” 

  • Psychedelics are a hot new biotech sector
  • See investment advisory websites such as:

            Psychedelic Finance (psychedelicfinance.com)

            Psychedelic Stock Watch (psychedelicstockwatch.com)

Rush for FDA approval by pharmaceutical companies and venture capitalists

  • Numerous publicly-traded psychedelic sector companies, mostly on Canadian exchanges but also some on US exchanges.
  • Some of the biggest: Atai Life Sciences (NASDAQ), Compass Pathways (NASDAQ), Cybin (NYSE), Mind Medicine (NASDAQ), Seelos (NASDAQ)
    Valuations for Atai and Compass reach the low billions: none of the start-ups have a product on the market.
  • In March 2022, US News and World Report cites a research firm for the proposition that the psychedelic drugs market will reach $10.75 billion by 2027 [https://money.usnews.com/investing/stock-market-news/slideshows/psychedelic-stocks-to-watch, accessed May 25, 2022]

This emerging sector is subject to occasional crashes.

V. Miscellaneous developments/legal issues

1. Right to Try litigation out of Washington State

Federal right to try law, 21 U.S.C. § 360-bbb et seq., authorizes use of drugs that have gone through FDA Phase I (safety) trials but not received final FDA approval by limited population of patients – sometimes limited to terminal patients. Function of a right to try system requires corresponding state law.

  • Washington State oncologist Sunil Aggarwal sought to provide psilocybin to some of his terminally-ill patients for severe anxiety and depression under Washington’s right to try law.
  • His position: psilocybin is being investigated in multiple clinical trials and therefore should be eligible for access under Washington’s right to try law.
  • Dr. Aggarwal requested guidance from the DEA as to how to register with the DEA to obtain psilocybin for his patients under the right to try law.  DEA responded with a letter stating that it has no authority to grant a waiver for therapy under the federal Right to Try law because that law does not refer to the CSA.
  • Dr. Aggarwhal and his patients brought a petition challenging what they characterized as a final agency action. The Circuit Court dismissed the petition on the grounds that the DEA response was not a final agency action and therefore the Court had no jurisdiction to review it.  AIMS v. Garland, 24 F.4th 1249 (9th Cir. 2022)
  • In response, Dr. Aggarwal filed a petition to move psilocybin from Schedule I to Schedule II. [https://emergelawgroup.com/2017/wp-content/uploads/2022/02/Rescheduling-Petition.pdf, last accessed May 26, 2022]
  • Dr. Aggarwal and others commenced an action challenging DEA’s refusal to respond to FOIA requests as to whether it received the rescheduling petition and a petition for exemption of psilocybin from CSA in the context of Right to Try use. AIMS Institute, et al., v. Garland, et al., 4:22-cv-02396 (S.D. Texas)
  • U.S. Senators Booker and Paul have introduced a bill to amend the federal Right to Try Act to include Schedule I substances. S. 4575

    2. State law action alleging undue influence resulting in part from psychedelic use

“A psychedelic therapist allegedly took millions from a Holocaust survivor, highlighting worries about elders taking hallucinogens,” Olivia Greenhill, Stat, April 21, 2022. https://www.statnews.com/2022/04/21/psychedelic-therapist-allegedly-took-millions-from-holocaust-survivor-highlighting-worries-about-elders-taking-hallucinogens/ [accessed May 26, 2022]

According to the article, daughters of a wealthy, elderly man brought an action against a younger romantic companion who they alleged had unduly influenced him to provide her and her husband with substantial financial benefits. Sarko v. Dulai, Superior Court, Marin County (FL 2101372).
Defendant is a well-known advocate of psychedelic therapy. The alleged victim, a refugee from the Holocaust and Communist Hungary, supported psychedelic research and took psychedelics with the defendant.

Clinical trials testing psychedelics involve therapists meeting with patients before, during, and after their psychedelic experience. People who take psychedelics report they create feelings of emotional intimacy, heightening the susceptibility that already exists between patients and health care providers. Moreover, the drugs are being explored as a way to ease patients’ anxiety at the end of life. And yet it’s unclear whether psychedelic therapists will be required to meet the same licensing standards as other therapists such as psychiatrists and psychologists.

“It’s a whole new frightening possibility of elder abuse,” Donovan Maust, a geriatric psychiatrist and health services researcher at the Michigan Medicine Department of Psychiatry, said about the risks faced by older people treated with psychedelics.

The lawsuit alleges Dulai used drugs including ayahuasca and MDMA to heighten Sarlo’s dependence on her, and as Sarlo’s health deteriorated, she introduced him to ketamine and supervised an “intensive” dosing regimen. Meanwhile, Sarlo bought her a Porsche and loaned her $1.4 million to purchase a home now worth an estimated $2.3 million for her and her husband in Mill Valley, an affluent city in Marin County, just north of San Francisco. He later forgave the loan, turning it into an outright gift.

The article reports that the action was settled.

3. Intellectual property

This topic is outside the scope of this presentation, but one concern in the reform movement is that the big pharmaceutical developers are filing overbroad patent claims in an attempt to capture the market.

VI. State and local level legislative reform

While psychedelics are not “the new cannabis,” the movement towards psychedelic law change largely tracks the movement that achieved change in cannabis law:

  • Local initiatives ‘deprioritize’ psychedelic law violations and defund enforcement actions by local government employees
  • State law (Oregon only, the first law to pass) creates a regulated ‘medical’ access system very roughly analogous to a medical cannabis system
  • California activists seek to pass an initiative that will legalize a general adult use “tax and regulate” commercial retail market
  • State level decriminalization bills have emerged recently
  • Many of the actors in psychedelic legalization advocacy come from cannabis legalization advocacy – the legal cannabis market has provided an infrastructure for psychedelic legalization and the understanding that cannabis prohibition is a historical error provides a conceptual understanding of a reason to change the legal status of psychedelics.
  • As with cannabis, decriminalizing use and possession by individuals – the “demand side” of the market – is relatively easy.
    This is the basic approach of local law change.
  • More difficult is changing the status of the supply side of the market: manufacturers, wholesalers, distributors, retailers (whether pharmacists, treatment providers, or retailers), which presumably must happen under state law.
  1. The local level

Denver – the beginning

On May 7, 2019, Denver voters passed Initiated Ordinance 301.

  • Enforcement of laws imposing criminal penalties for the personal use and personal possession [defined to include “propagation,” i.e. cultivation] of psilocybin mushrooms shall be the lowest law enforcement priority in the City and County of Denver.
  • Prohibits all officers and employees of the City from using any city funds or resources to assist in enforcement of laws imposing criminal penalties for personal use and personal possession of psilocybin mushrooms by adults.
  • Requires the Mayor to appoint an 11-person “Psilocybin Mushroom Policy Review Panel” to assess and report on the effect of the legal change to the Mayor and the Council. That document, released in November 2021, constitutes the first governmental analysis of psychedelic policy

Oakland – The Decriminalize Nature movement follows quickly           

Activists in Oakland created “Decriminalize Nature” advocacy group soon after Denver activists got I-301 on the ballot

  • On June 4, 2019, the Oakland City Council passed a resolution authored by Decriminalize Nature which decriminalized the possession and use of naturally-occurring psychedelic substances as a category.
  • As opposed to the Denver approach of focusing on a specific substance, the resolution covers a category of matter called “Entheogenic Plants.”
  • Entheogenic Plants are defined as “plants and natural sources…such as mushrooms, cacti, iboga containing plants and/or extracted combinations of plants similar to Ayahuasca; and limited to those containing the following types of compounds: indole amines, tryptamines, phenethylamines.”
  • The Decriminalize Nature movement explicitly invokes sacred character of naturally-occurring psychedelic substances, millennia-old traditions of religious use, and spiritual growth from use of Entheogenic Plants.
  • It also expresses opposition to the role of for-profit corporations in “plant based healing and psychedelic medicine spaces,” i.e, what might be characterized as an anti-capitalist or anti-commodification position, and focuses on Entheogenic Plants as a means of addressing trauma caused by racism.
  • It has proposed an ordinance – the Oakland Community Healing Initiative Pilot Program to create a not-for-profit structure for the supply side of the market under the auspices of the City Council.
  • There are Decriminalize Nature chapters in cities across the United States

Other local governments that have passed reform laws (decriminalization, deprioritization) since Oakland:

Ann Arbor, MI

Arcata, CA

Cambridge, MA

Hazel Park, MI

Northampton, MA

Santa Cruz, CA

Seattle, WA

Somerville, MA

Washington D.C. (does not provide for defunding of enforcement of laws against Entheogenic Plants due to Congressional control over D.C. budget)

Washtenaw County, MI

Detroit, MI

Many of these grass-root, anti-commodification efforts have been conducted by local Decriminalize Nature chapters

Seattle is the largest urban area to date in which decriminalization has taken place

The San Francisco City Council has voted to put a decriminalization measure before the voters

2. State level reform

Lead legislative model: Licensed “psychedelic services” system in Oregon

Oregon opened the door to state-level reform

The Oregon Psilocybin Services Initiative (Oregon Measure 109) passed on November 3, 2020, with 56% of the vote


Oregon Revised Statutes Title 14 Section 475A

  • Creates a clinic model for onsite consumption of “psilocybin products”
  • Distant family relationship to a state medical cannabis system with licensure/prior approval of all participants: (a) manufacturer, (b) psilocybin service center operator, (c) psilocybin services facilitator, and (d) testing laboratory
  • Places regulatory authority in Oregon Health Authority
  • Grants extensive discretion to OHA in formulating the particulars of the entire system through regulation, e.g., qualifications to be a manufacturer, requirements for “psilocybin products,” qualifications to operate a psilocybin services center, form of “psilocybin services” modalities (explicitly provides for three stages: Preparation Session, Administration Session, Integration Session), and qualifications to be psilocybin services facilitator.
  • It is an attempt to maintain very low barriers to entry into the market, e.g., by including in the statute minimal requirements for licensure other than standard good character requirements, 2-year residency requirement, and age minimum.
  • It is an open question how this model will interact with the market model of FDA-approved prescriptions
  • Oregon is where the main action is taking place in the US as the advisory committee – chock-full of subject matter experts – has gone through the process of formulating proposed regulations and has referred them to the regulatory agency

Legislation following the Oregon model has appeared in numerous states, e.g., Florida, Hawaii, Maine, Washington, and, as tweaked to include decriminalization, Colorado and New Jersey.

None has passed yet.

Some other models

Deschedule: remove one or more substances from state-controlled substances list:

– Iowa, Vermont, New York

Adult use/ “tax-and-regulate” system for psilocybin

– California voter initiative

  • Declaration that possession, use, and other actions in market are “not unlawful”
    – California legislation

Research

Enacted in Texas

  • Directs Health and Human Services Commission in collaboration with Baylor College of Medicine and in partnership with a military veterans hospital or a medical center that provides medical care to veterans, to conduct a study on the efficacy of using alternative therapies, including the use of 3,4-methylenedioxymethamphetamine (MDMA), psilocybin, and ketamine, in the treatment of veterans who suffer from post-traumatic stress disorder
    (New York’s research bill differs.)

Right to try

Some states exclude Schedule I substances from the scope of drugs that are eligible.

Missouri: 2022 Regular Session HB 249

  • Deletes provision from Missouri’s right to try law that excludes Schedule I substances
  • Adds text stating that:

production and distribution of any Schedule I psychedelic drug that qualifies as an investigational drug under…this section by a manufacturer and any dispensation of such drug by a physician or pharmacy for use in accordance with this section shall be considered lawful.

3. Colorado, New Jersey, and New York

A. Colorado – Natural Medicine Health Act

A ballot initiative will appear in the November 2022 general election

  • New paradigm: combines licensed psilocybin-assisted therapy with decriminalization
  • Also radically expands the scope of therapy options in that it provides for phase-in in June 2026 of licensed access to other naturally-occurring psychedelics, including DMT, ibogaine, and mescaline (other than derived from peyote cactus) – but not LSD or MDMA (which is ironic because LSD has a lower physiological risk profile than does ibogaine), and decriminalization of those substances (the definition of “natural medicine” will expand from just psilocybin to that range of substances)
  • This model is essentially the Oregon model with some of the expansions in new iterations: expands range of venues in which administration session can take place – at home, other health care facility – AND decriminalizes non-commercial activity
  • 12-170-109 provides for decriminalization of a full spectrum of actions under the rubric “personal use,” including possession, cultivation, and sharing/gifting
  • Section 12-170-107 (“Localities”) authorizes local governments to enact time, place, and manner restrictions but they cannot ban the operation of licensees within their borders
  • 12-170-113 preemption: localities can reduce penalties but not increase them

    B. New Jersey –Psilocybin Behavioral Health Access and Services Act
  • S.2934 was introduced by Senate President Nicholas Scutari, a main mover in cannabis, in June of this year; he set psychedelic reform in motion in 2020 by introducing ultimately-successful legislation that decreased penalties for psilocybin possession
  • Model: like Colorado, combines licensing of market actors by state health care regulators with decriminalization of non-commercial activity, including cultivation, but just psilocybin
  • Equitable access program to assist with cost of psilocybin services
  • Licensees require letter from municipality location conforms with zoning requirements
  • Psychedelic services in private residence
  • A county or municipality may adopt regulations on operation of manufacturers and service centers

    C. New York – psilocybin-descheduling, research, and psilocybin-assisted therapy bills

There are three different bills pending in the Assembly: the research bill, the descheduling bill, and a psilocybin-assisted therapy bill

  • Assemblymember Linda Rosenthal took the lead in May 2020 when she introduced the psilocybin descheduling bill (A. 6065) and followed up with the research bill (A. 7928), which is not limited to psilocybin.
  • The impetus for the research bill is development of pharmacotherapies, presumptively ibogaine, to interrupt crystal methamphetamine use, which due to its association with unsafe sexual practices is a vector for HIV transmission.
  • MA Patrick Burke (Buffalo) opened wide the scope of reform when he introduced A. 8569, a psilocybin-assisted therapy bill in 2021
  • However, his bill does not follow the Oregon model; instead, it is, to a large extent, lifted out of early versions of the medical cannabis law, i.e., it follows the conservative medical model
  • As with medical cannabis, it requires patient certification by a licensed health care provider; while “patients” in other systems need not show that they have a specific medical condition in order to access psilocybin, the New York requires that the patient be certified as having a “condition”; like the early medical cannabis laws, the conditions are not enumerated – instead they are left to the discretion of the licensed professional
  • The supply side model is interesting and unique: it places licensing authority in the Department of Agriculture and Markets, which will oversee the Naturally Grown Medical Psilocybin Pilot Program, in conjunction with Department of Environmental Conservation, and perhaps not coincidentally co-sponsors include Donna Lupardo, Broome County, the Chair of the Committee on Agriculture, and Anna Kelles, Tompkins County, a Member of the Committee on Agriculture.
  • A grant program would assist three patient populations in accessing psilocybin: veterans, first responders, and low-income individuals; query whether this provision is politically viable in New York City due to its limitations
  • There are no provisions relevant to the authority of local governments

    D. A comment on local opt-out in Oregon
  • The Oregon statute provides for local opt-out (county, city) from the operation of psilocybin manufacturers and psilocybin service centers
  • County legislature votes on whether to send to the public in the next general election (November 2022) a vote on opt-out from operation of psilocybin service centers, whether as a two-year moratorium or ban
  • According to the Oregon Capital Chronicle as of August 8, 2022, out of 36 counties in Oregon, 24 have put an opt-out vote on the ballot, 8 have not, and 4 are undecided

    E. The report of the Denver Psilocybin Mushroom Policy Review Panel
  • As mandated by I-301, in November 2021, the Panel, which includes representatives of the Denver Police Department, Sheriff’s Department, District Attorney’s Office, and City Attorney’s Office, released its report on the effects of the Initiative.
    The Panel reported that decriminalization of psilocybin mushrooms did not present any significant public health or safety risk in the city and there had been no major increase in arrests related to the distribution of psilocybin mushrooms and no major cartel elements or organized crime.
  • However, the Panel also engaged in an involved review of psilocybin
  • The report recommended the following actions: train City and County of Denver first responders to recognize and safely respond to persons undergoing psychedelic crisis, produce educational public service announcements to inform the public about safety, responsible use, and available risk reduction services, create a data collection reporting system for any interactions involving psilocybin for ongoing public safety monitoring, make the sharing/gifting of psilocybin without remuneration among the lowest law enforcement priorities, make the communal use of psilocybin among the lowest law enforcement priorities, expand voting Panel members to be more representative of Denver’s diversity, and determine how psilocybin therapy can be applied to address mental health issues in Denver
  • To my knowledge the Panel is on hiatus; I am not aware of the status of their recommendations; I have been informed that Denver responders are continuing their training with representatives of the Multidisciplinary Association for Psychedelic Studies
  • See my interview with Kevin Matthews, the executive of the Decriminalize Denver campaign and the president on November 11, 2021

    VII. Options for New York City

Psychedelics seem to be naturally contiguous with numerous trending policy issues here – substance abuse, violence, depression, anxiety, PTSD.

Published journal material indicating on the basis of longitudinal material that psychedelic use is associated with reduced recidivism rates.

There is a large constituency of psychedelic consumers in New York City.

Many leading subject matter experts are here.

One option: the equivalent of the La Guardia Commission Report on cannabis in 1944 but focusing on psychedelics with the Denver report as a model.

  • hearings with testimonials
  • review of published research
  • analysis of budgetary impacts of equitable legal access to psychedelics

[1] I argue that cannabis is actually subsumed within the psychedelic paradigm. (As a purely technical matter, federal and New York law classify cannabis as a psychedelic.) It partakes of limited aspects of the opioid paradigm, but I consider it a highly versatile form of psychedelic—the most widely used—that lends itself to a mass over-the-counter market in a way that other psychedelics (with possible exception of psilocybin) do not—at least currently. For the purposes of this discussion, I will treat cannabis as outside the psychedelic paradigm.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s