9 papers in the library · publishing 2026
SSRN Electronic Journal 2026 Vincent Joralemon
As the psychedelic-medicine sector expands from a fringe area into a substantial commercial industry, stakeholders are increasingly investing in lobbying and public-comment campaigns to shape the regulatory frameworks that will govern psychedelic therapies. This essay revisits the classical concept of "regulatory capture"-as articulated by George Stigler-and applies it to the contemporary...
SSRN Electronic Journal Vincent Joralemon
MDMA is currently a Schedule I controlled substance, the most restrictive category under the Controlled Substances Act. But Lykos Therapeutics' (formerly MAPS PBC) pending New Drug Application for MDMA-assisted therapy as a treatment for PTSD may force the Drug Enforcement Administration's hand: FDA approval supplies the "accepted medical use" that Schedule I drugs are statutorily denied,...
Julia Etkin, Vincent Joralemon
Psilocybin is currently classified as a Schedule I controlled substance under the Controlled Substances Act-the federal designation reserved for substances deemed to have no accepted medical use and a high potential for abuse. Yet by comparative-harm metrics, psilocybin ranks among the safest psychoactive compounds in widespread use, far safer than alcohol and tobacco, both of which are...
Ketamine’s path from anesthetic to antidepressant reframed treatment-resistant depression (TRD) by shifting focus from monoamines to glutamate/NMDA modulation. This Article traces the science (from Yale–NIMH pilot work through Zarate 2006), synthesizes evidence across routes of administration (IV, IM, oral, sublingual, intranasal) with bioavailability tradeoffs, and explains why esketamine...
Vincent Joralemon preprint
FDA REMS and ETASU for psychedelic therapy—psilocybin, MDMA, and Spravato (esketamine)—can enhance safety yet impose clinic-only administration that limits access. Using Spravato’s REMS as precedent, this Article shows how “every-use” in-person supervision and limited distribution increase cost and strain providers even as adverse events cluster early in treatment. It proposes a...
As psychedelic-assisted therapies advance through the FDA approval pipeline, the question of who will pay for them is moving from academic to urgent. Experts project that MDMA-assisted therapy for PTSD will cost upwards of $11,000-$12,000 per course of treatment-a price tag that, absent insurance, places these therapies out of reach for many of the patients most likely to benefit. This essay...
Vincent Joralemon preprint
The term “psychedelic” lacks a consensus definition, yet a growing body of regulatory and commercial infrastructure—FDA clinical-trial guidance, AMA reimbursement codes, research grants, and insurance coverage decisions—turns on whether a given substance falls within the category. This short essay argues that the boundaries of the “psychedelic” label are doing significant normative work that is...
Clinical trials for novel therapeutics are extraordinarily expensive, and psychedelicassisted therapies pose a particular financing challenge: the underlying compounds (MDMA, psilocybin, LSD, ibogaine) are off-patent or unpatentable, limiting the traditional commercial incentives that fund late-stage drug development. This essay examines an emerging alternative-the "pseudo-nonprofit" financing...
Psychedelic therapies—ketamine, MDMA, psilocybin, LSD, DMT, and ibogaine—are moving from prohibition to regulated care, but commercialization hinges on FDA approval, DEA scheduling, and payor (insurance) coverage. This Article maps the U.S. regulatory labyrinth and analyzes how business models succeed or fail under these constraints. It explains bifurcated rescheduling (DEA reschedules the...