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Psychedelic Policy on the Federal Level: Key Takeaways from a Petrie-Flom Center Panel

April 26, 2022April 26, 2022 James Jolin Leave a comment

By James R. Jolin

To navigate the myriad interests and stakes involved in creating federal psychedelic policy, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School convened a virtual panel discussion with three leading psychedelic policy advocates.

The conversation was situated against the backdrop of the “psychedelics renaissance” in the United States, which has been fueled by a wave of local and state legislation reducing or eliminating the criminal penalties associated with these substances.

Though many localities have made significant strides in addressing the legal questions surrounding psychedelic substances such as psilocybin and dimethyltryptamine (DMT), federal policymakers have not pursued similar initiatives.

Suggestions and considerations for federal psychedelic policy thus formed the substance of the discussion among the panelists:

The Biden Administration Should Resolve Cannabis Regulation Chaos

August 13, 2021August 12, 2021 The Petrie-Flom Center Staff Leave a comment

By Troy Sims

The Biden Administration has the opportunity to be the first administration to rid our legal system of cannabis regulation chaos.

State laws governing medical or recreational cannabis conflict with federal regulations, leaving cannabis consumers, businesses, and the lawyers representing them caught in the middle.

Guidance documents from the Department of Justice (DOJ) are an often-overlooked source of complexity and confusion in the cannabis industry. The Biden administration should seek to reconcile state and federal cannabis law.

Traditional countryside scene in the Netherlands with windbreak lane of poplar trees in the wind under summer sky. Ens, Flevoland Province, the Netherlands.

Q&A with Mason Marks on New Psychedelics Law and Regulation Initiative

July 1, 2021July 1, 2021 Chloe Reichel Leave a comment

By Chloe Reichel

On June 30th, the Petrie-Flom Center announced the launch of a three-year research initiative, the Project on Psychedelics Law and Regulation (POPLAR), which is supported by a generous grant from the Saisei Foundation.

The Project on Psychedelics Law and Regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will advance evidence-based psychedelics law and policy.

In 2017, the FDA designated MDMA a breakthrough therapy for post-traumatic stress disorder, and in 2018 the agency recognized psilocybin as a breakthrough therapy for treatment-resistant depression. These designations indicate that psychedelics may represent substantial improvements over existing treatments for mental health conditions. Many other psychedelics, including ibogaine, ketamine, and dimethyltryptamine, are the focus of ongoing psychiatric research and commercialization efforts.

Despite the proliferation of clinical research centers and increasing private investment in psychedelic drug development, there is a relative lack of research on the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics.

In the following interview, which has been edited and condensed, Senior Fellow and POPLAR Project Lead Mason Marks explains how POPLAR will fill this gap, and previews some of the initiative’s topics of inquiry.

A Sensible, Evidence-Based Proposal for Kratom Reform

June 8, 2021June 7, 2021 Dustin Marlan Leave a comment

By Dustin Marlan

In May 2021, the U.S. Food and Drug Administration (FDA) announced the seizure of 37,500 tons of adulterated kratom in Florida, worth an estimated $1.3 million.

But rather than focusing on the fact that the seized substance was adulterated, FDA Commissioner Janet Woodcock emphasized the alleged toxicity of kratom. This telling choice falls in line with recent efforts by the FDA to end U.S. kratom sales, distribution, and use, including a failed 2016 attempt to have kratom placed into Schedule I of the Controlled Substances Act, along with other federally prohibited drugs such as cannabis, psilocybin, and heroin.

This reactionary prohibitionism is likely to do more harm than good. Moreover, it does not reflect the state of the science, which remains unsettled as to kratom’s risks and benefits.

How Supervised Injection Sites Can Help Address the Overdose Crisis

March 26, 2021March 26, 2021 The Petrie-Flom Center Staff Leave a comment

By Carly Roberts

Supervised injection sites, also known as safe injection sites, are among the most effective, evidence-based harm reduction tools available to counter the opioid overdose crisis.

Supervised injection sites are legally sanctioned locations that provide a hygienic space for people to inject pre-obtained drugs under the supervision of trained staff. Safe injection sites often provide additional services including needle exchanges, drug testing (especially important for detecting lethal fentanyl-laced drugs and preventing “mass overdose” events), and referral to treatment and social services.

The opioid overdose crisis in the U.S., which had a death toll of over 45,000 in 2018, and which is predicted to worsen amid the COVID-19 pandemic, warrants a bold, brave, and thorough response. Harm reduction programs, including supervised injection sites, should be integrated into opioid epidemic response strategies in order to save lives and improve individual and community outcomes.

New York, NY/USA - 08.31.2018: Overdose Awareness March.

Advancing a Public Health-Promoting National Opioid Policy

March 23, 2021March 23, 2021 The Petrie-Flom Center Staff Leave a comment

Register to attend “Addressing the Overdose Epidemic: Substance Use Policy for the Biden Administration” on March 24th.

By Jennifer D. Oliva & Kelly K. Dineen

“America’s drug regime is a monstrous, incoherent mess.”

– Dr. Carl L. Hart, Drug Use for Grown-Ups: Chasing Liberty in the Land of Fear (2021)

By any measure, American drug policy is an ineffective and costly failure.

The U.S. drug policy regime’s defining quality is its persistent adherence to the same approaches in the face of overwhelming evidence that they are unsuccessful, including supply-side tactics, fear mongering, and misinformation dissemination. These policies are racist by design and their myriad, negative impacts are disproportionately borne by marginalized and stigmatized communities.

The “war on drugs” and its repeated loop of lost battles have earned the nation the highest incarceration rate in the world, fomented a number of serious health issues related to drug use, and fueled a drug overdose and suicide crisis. Our shape-shifting overdose crisis recently claimed the highest number of overdose deaths ever recorded during a twelve-month period in American history.

Bold Steps Needed to Correct Course in US Drug Policies

March 22, 2021April 27, 2021 The Petrie-Flom Center Staff Leave a comment

By Leo Beletsky, Dan Werb, Ayden Scheim, Jeanette Bowles, David Lucas, Nazlee Maghsoudi, and Akwasi Owusu-Bempah

The accelerating trajectory of the overdose crisis is an indictment of the legal and policy interventions deployed to address it. Indeed, at the same time as the U.S. has pursued some of the most draconian drug policies in the world, it has experienced one of the worst drug crises in its history.

The legal and institutional system of U.S. drug control remains defined by its racist, xenophobic, and colonialist roots. It is no surprise, then, that current policy approaches to drug use have amplified inequities across minoritized and economically marginalized Americans. Reliance on the criminal-legal system and supply-side interventions have disproportionately devastated Black and brown communities, while failing to prevent drug-related harms on the population level.

The Biden-Harris Administration has an unprecedented opportunity to chart a different path. The priorities for the Administration’s approach should flow directly from its stated principles: emphasis on scientific evidence and a focus on equity.

The following key areas require immediate, bold, and evidence-grounded action.

America divided concept, american flag on cracked background.

Can Psychedelics Help Save America?

November 2, 2020October 30, 2020 The Petrie-Flom Center Staff Leave a comment

By Shelby Hartman

Amid a fractured political landscape, an unprecedented pandemic, and a reckoning with the country’s racist past, psychedelics may offer some hope for healing in the United States. In recent decades, a renaissance of psychedelic drug research has grown at prominent institutions like Johns Hopkins, New York University, and Imperial College London, among others.

Psilocybin, the psychoactive component in psychedelic mushrooms, and MDMA, sometimes confused with its adulterated version, ecstasy, have both been given breakthrough therapy status by the Food and Drug Administration (FDA), because they’ve shown so much promise for treating conditions for which we currently have few effective options. Psilocybin for treatment-resistant depression and MDMA for post-traumatic disorder are projected to be legal within the next five years as drugs that will be administered under the supervision of trained therapists.

The False Promise of City-Wide Psilocybin Decriminalization

October 30, 2020November 12, 2020 The Petrie-Flom Center Staff Leave a comment

By Kathryn Lucido

While city-wide decriminalization of psilocybin is a positive step toward decreasing the impact of the war on drugs, it also creates a false sense of security and progress.

Citing new research that illustrates the therapeutic promise of the drug, several U.S. cities have decriminalized psilocybin, a psychedelic compound that occurs naturally in some fungi. Though these cities have pledged not to spend resources prosecuting people for psilocybin possession, and, in some cases, limited distribution, the substance remains illegal at the federal, state, and city levels.

Psilocybin remains a Schedule I drug under the Controlled Substances Act. This classification means that — at least according to Congress and the Drug Enforcement Administration — psilocybin is a dangerous drug with no currently accepted medical uses and a high risk for abuse.

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