Tag: DEA

Silver Spring, MD, USA - June 25, 2022: The U.S. Department of Health and Human Services (HHS), U.S. Public Health Service (USPHS) and FDA logos are seen at the FDA headquarters, the White Oak Campus.

The FDA Backdoor to MDMA Rescheduling

Vincent Joralemon Leave a comment

By Vincent Joralemon

MDMA (also known as the club drug “molly” or “ecstasy”) is a Schedule I controlled substance — the most restrictive drug class with the most severe criminal consequences linked to it. But, perhaps not for long.

A recent effort to get MDMA approved by the U.S. Food and Drug Administration (FDA) for post-traumatic stress disorder (PTSD) means the drug may be rescheduled, which will lead to substantially decreased regulations attached to it. This provides a compelling model for efforts to decriminalize and destigmatize other substances moving forward.

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Doctor working with modern computer interface.

Thank Ketamine for the Telehealth Extension

Vincent Joralemon Leave a comment

By Vincent Joralemon

In my last post, I discussed the rise of psychedelic lobbying — how companies with vested economic interests in psychedelics have applied pressure to shape regulations that favor their business models.

One such initiative — the ketamine therapy industry’s push to extend the COVID-era telemedicine flexibilities for prescriptions of controlled substances — highlights how sophisticated these campaigns can be, and how their impact stretches beyond the psychedelic industry.

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United States Capitol Building - Washington, DC.

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

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:

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Cannabis in clear glass jars.

The Biden Administration Should Resolve Cannabis Regulation Chaos

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.

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Kratom leaves and capsules.

A Sensible, Evidence-Based Proposal for Kratom Reform

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.

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medical needles in a pile

How Supervised Injection Sites Can Help Address the Overdose Crisis

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.

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

Advancing a Public Health-Promoting National Opioid Policy

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.

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

Bold Steps Needed to Correct Course in US Drug Policies

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.

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The Prescription Drug Abuse and Overdose Crisis: Focus on the Supply Chain

Temple University Center for Public Health Law Research Leave a comment

By Scott Burris

There’s so much we still don’t know about the prescription opioid problem. The partial remedies advanced so far reflect this:

  • Prescription Drug Monitoring Programs, which in essence define the problem as doctor-shopping patients;
  • treatment guidelines, which define the problem as doctors without expertise; and
  • crackdowns on “pill-mills,” which see the issue as physician corruption. Each of these diagnoses has an element of truth, but not necessarily enough to make the treatments effective.

One huge part of the problem has gotten far too little attention: the pharmaceutical supply chain where all these drugs start and along which they are distributed. Now, John Coleman, a former DEA officer, has given us a thorough and compelling primer on the supply chain, describing it and showing where the pressure points are for action. He is not happy about what he sees: DEA is overwhelmed, and too secretive with its data;  and the distributors are too interested in profits and far too unwilling to police paying customers. But he also sees room for action and even hope. This article is well worth a read if you are interested in the overdose problem and how to solve it:

Coleman, John J. “The Supply Chain of Medicinal Controlled Substances: Addressing the Achilles Heel of Drug Diversion.” Journal of Pain and Palliative Care Pharmacotherapy 26, no. 3 (2012): 233-50.

P.S. — One of the hopeful signs he sees was Florida’s legislation beefing up state-level monitoring and controls. This takes me back to the successful Wisconsin Cancer Pain Initiative in the 70s and 80s, which articulated the Principle of Balance in drug control and demonstrated that it was possible to have good access to pain medicine and effective control. In those days, David Joranson, the state drug controller, worked closely with DEA, using state regulatory authority to shut down docs and pharmacies who were acting outside the law. The possibility of history repeating itself is a ray of sunlight in the cloudy skies of this issue. (If you are interested in the story, here’s one place to start: Joranson, D., and J. L. Dahl. “Achieving Balance in Drug Policy: The Wisconsin Model.” In Advances in Pain Research and Therapy, edited by CS Hill Jr. and WS Fields. 197-204. New York: Raven Press, 1989.)