Businessman's hands typing on laptop keyboard in morning light

Microdosing at Work: Business and Legal Implications

By Vincent Sliwoski

In light of the widespread cultural and business culture adoption of microdosing, private sector employers should reconsider the implications of a blanket prohibition on workplace use of controlled substances.

Microdosing is the practice of ingesting subperceptual amounts of psychedelic drugs, such as psilocybin mushrooms or LSD. People microdose for a variety of reasons. These may include medical reasons, such as the treatment of anxiety, depression or attention disorders; or they may include “performance” reasons, like attempts to increase productivity, creativity or awareness.

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POPLAR affiliated reseachers

Introducing Affiliated Researchers for the Project on Psychedelics Law and Regulation

(Clockwise from top left: Kwasi Adusei, Ismail Lourido Ali, Jonathan Perez-Reyzin, Dustin Marlan.)

We are excited to welcome our inaugural group of affiliated researchers for the Project on Psychedelics Law and Regulation (POPLAR). Through regular contributions to Bill of Health, as well as workshops and other projects, POPLAR affiliated researchers will share their expertise and perspectives on developments in psychedelics law and policy. We look forward to learning from and sharing their insights with our audiences. Keep an eye out for their bylines!

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Dried psilocybe cubensis psilocybin magic mushrooms inside a plastic prescription medicine bottle isolated on white background.

What Macrodosing Can Learn from Microdosing

By Dustin Marlan

Following a recent wave of unbridled positivity culminating in a “shroom boom,” the psychedelic renaissance now finds itself under fire amidst concerns of predatory capitalism, cultural appropriation, adverse psychological effects, and sexual abuse and boundary issues by guides and therapists.

Nonetheless, the psychedelics industry is moving ahead at full speed. Oregon will begin accepting applications from businesses to run psilocybin service centers in January 2023. MDMA clinical trials are nearing completion and expected to result in FDA approval. And corporations are readying psychedelic compounds — natural and synthetic — to produce and deliver to the masses.

All of this begs the question of how psychedelics dosage should be regulated, particularly where, as journalist Shayla Love points out, “there’s reason to worry that there hasn’t been enough preparation for negative outcomes amidst the hype.”

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LSD Microdosing. Small or micro doses of LSD drug cut from a tab, presented on a finger.

A Precise Definition of Microdosing Psychedelics is Needed to Promote Equitable Regulation

By Sarah Hashkes

When we talk about microdosing psychedelics, it’s important we have a mutual understanding of its definition to be able to conduct accurate research, promote regulations, and educate the wider population. This article will look at three main questions and ambiguities regarding the term “microdosing psychedelics” and suggest a definition that would help promote coherence in the field.

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yellow capsules on a blue background.

Fatty Acids, Skinny Labels: Fish Oil Patent Battle Back in Court

By Gregory Curfman

An ongoing patent battle over omega-3 fatty acids, colloquially known as as fish oils, may have broad implications for the marketing of generic drugs.

Icosapent ethyl (Vascepa®) is an omega-3 fatty acid preparation used to treat high triglycerides.  It was explicitly designed to be different from most other omega-3 fatty acid preparations — instead of containing a mixture two fatty acids (docosahexaenoic acid and eicosapentaenoic acid), it is a purified preparation of just the latter, and it is a much higher dose than what is typically used.

On the basis of the ANCHOR and MARINE clinical trials, in 2012 the Food and Drug Administration (FDA) approved Vascepa for the treatment of persons with severe hypertriglyceridemia.

In 2015, Hikma Pharmaceuticals, a generic drug company, filed an abbreviated new drug application (ANDA) for its generic formulation of icosapent ethyl.

The manufacturer of branded Vascepa, Amarin Corporation, promptly filed a patent infringement lawsuit citing six method of use patents (the ‘728, ‘715, ‘677, ‘652, ‘560, ‘929 patents) on Vascepa that the company believed were infringed by Hikma’s ANDA.

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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

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.

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Steps 1, 2, 3, 4 signpost.

The Ongoing Step Therapy Debate

By Laura Karas

Senator Lisa Murkowski’s (R-AK) reintroduction this February of a federal bill, the Safe Step Act, has revived the debate over the prudence of step therapy protocols.

Step therapy is an insurer utilization-management tool imposed in response to high drug prices. As its name implies, step therapy requires “steps” before a patient can receive his preferred medication (i.e., the one his provider has prescribed). Typically, a patient must “try and fail” a less costly medication or series of medications before becoming eligible for insurance coverage of the medication in question. In effect, step therapy allows an insurer’s “preferred therapy” to supersede patient and provider preference.

The need for step therapy is closely bound to the problem of high drug prices. But the crux of the step therapy debate boils down to the following: Who should decide which pharmaceutical drugs your health plan covers? You and your doctor, or your insurer?

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Drone hovering in air above mountain range.

Drone-Enabled Pharmaceutical Delivery: Navigating Regulatory Turbulence

By Vrushab Gowda

The burgeoning industry of drone-enabled pharmaceutical delivery offers a number of advantages over its low-tech forebears, not least including patient convenience.

It minimizes exposure to infection and potentially protects patient anonymity, all while reducing wait times relative to in-person or traditional mail-order pharmacies. Additionally, drones can broaden access to medications in resource-poor areas, including locations with low densities of health care facilities, and those where underdeveloped transportation links hinder ground delivery.

However, drone delivery of pharmaceuticals enters into a nebulous legal environment, sitting as it does at the intersection of healthcare, privacy law, and aviation regulation. It is, moreover, a dynamic landscape, which continues to evolve with new federal rules, judicial decisions, and corporate practices.

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gavel on top of a pile of bills and pills

Federal Court Halts Implementation of 340B Dispute Resolution Rule

By Sravya Chary

The U.S. District Court for the Southern District of Indiana’s recent decision to grant Eli Lilly’s motion for a preliminary injunction rightfully halted the implementation of a dispute resolution rule for the 340B Drug Pricing Program.

The Alternate Dispute Resolution Final Rule (“ADR Final Rule”), issued on December 10, 2020, attempted to settle oft-occurring battles between pharmaceutical manufacturers and 340B covered entities. A few weeks later, the Department of Health and Human Services (HHS) released a 340B advisory opinion defining the department’s understanding of the statute.

The 340B Drug Pricing Program was established by Congress in 1992 with the intent to stretch federal resources to serve the nation’s most vulnerable patients. In practice, however, the program has deviated from its original intent.

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