The pressure is ramping up on the U.S. Drug Enforcement Administration (DEA) as more lawyers, clinicians, researchers, investors and business owners working in the psychedelics industry are demanding clear answers about how the DEA should be evolving on its drug scheduling and enforcement strategy.
The DEA’s Schedule II of supposedly less harmful drugs include cocaine, oxycontin, fentanyl and Adderall.
Less harmful? In 2021, the United States suffered more fentanyl-related deaths than gun- and auto-related deaths combined, according to the DEA. There were 1,305 deaths from cocaine in the first six months of 2021 in Florida alone.
Clearly, these Schedule II drugs are much worse substances than the psychedelics listed on Schedule 1. This misguided scheduling of psychedelics represents an insight into the contradictions and plain bad decision-making within the DEA that is coming under increased scrutiny.
DEA Issue List
Here is a list of more actions that are mixing up the DEA in a tangled web of two-steps-forward-three-steps-back events over just the last year:
– October 13, 2021. Novamind Inc. (CSE: NM | OTCQB: NVMDF | FSE: HN2), a mental health company specializing in psychedelic medicine, announced it was been granted two Schedule 1 licenses from the DEA: one for Dr. Reid Robison, Novamind’s chief medical officer, and one for Dr. Paul Thielking, the company’s chief scientific officer. The DEA licenses are required for research sites planning to host clinical trials for psilocybin, enabling principal investigators to store and administer this controlled substance.
– November 4, 2021. Cybin Inc. (NEO:CYBN) (NYSE American:CYBN), announced that it was granted a Schedule I manufacturing license from the DEA for the company’s research lab in the Boston area.
– January 14, 2022. The DEA shocked industry watchers with a proposed rule putting relatively obscure psychedelic substances on Schedule 1—4-Hydroxy-N,N-diisopropyltryptamine (4-OH-DiPT); 5-Methoxy-alphamethyltryptamine (5-MeO-AMT); N-Isopropyl-5-Methoxy-N-Methyltryptamine (5-MeO-MiPT); N,N-Diethyl-5-methoxytryptamine (5-MeO-DET), and N, N-Diisopropyltryptamine (DiPT). The DEA based their decision on scientific and medical evaluations by U.S. Department of Health and Human Services (HHS) from 2012, after the DEA had been gathering information about the substances since 2008… leading to suspicions about the January, 2022 timing of this scheduling proposal which came just a day after the National Institutes of Health hosted a two-day psychedelics workshop about research gaps and opportunities in psychedelic drug development. The DEA proposal immediately prompted a flurry of outrage from the psychedelics community. Nearly 600 comments were collected, ranging from sarcastic historical review to downright disbelief. DEA identified 31 domestic suppliers of one or more of the listed substances; thirty of the 31 domestic suppliers are not registered with DEA to handle controlled substances and, if the proposal became DEA policy, would have to turn in their supplies. They would not likely be able to buy a DEA license. The DEA reported that it expected the lost sales to these small businesses to be minimal.
– January 18, 2022. U.S. Congressman Earl Blumenauer (D-OR) led a bipartisan group of six lawmakers in urging the DEA to stop blocking terminally ill patients’ access to therapeutic psilocybin treatments.
– May 9, 2022. More than a dozen activists staged a “die-in” outside the DEA headquarters in Arlington, Virginia, demanding that the DEA allow patients with life-threatening conditions to legally access psilocybin. 17 are arrested.
– July 6, 2022. DEA reported that it received numerous comments and four requests for a hearing on their proposed rule, as provided in 21 U.S.C. 811(a). They scheduled a public hearing on the rule for August 22, 2022.
– July 19, 2022. Dr. Sunil Aggarwal, who specializes in palliative care and is the co-founder and co-director of the AIMS Institute, an advanced integrative medical care facility for patients living with chronic and serious illness, sued the DEA, along with other plaintiffs, over their policy and pattern of “flagrant Freedom of Information Act abuse” regarding requests for the DEA to provide information about reclassifying psilocybin from a schedule I controlled substance to a Schedule II controlled substance. The plaintiffs also requested a waiver about access to psilocybin for limited therapeutic use under state and federal Right to Try Laws (RTT).
– July 20, 2022. U.S. Senators Cory Booker (D-NJ) and Rand Paul (R-KY), supported by Rep. Nancy Mace (R-SC) and Rep. Earl Blumenauer (D-OR), introduced legislation to clarify the Right to Try Act (RTT), which permits/allows eligible patients to have access to eligible investigational drugs. RTT is designed to allow terminally ill patients to have access to Schedule I drugs for which a Phase 1 clinical trial has been completed. Specifically, the Booker/Paul legislation, the Right to Try Clarification Act, would remove any obstacle from the DEA’s Controlled Substances Act and Schedule I substances listing to get access to drugs such as MDMA and psilocybin.
– July 22, 2022. The DEA’s scheduling proposal is withdrawn. “Upon further consideration, DEA has determined that it is appropriate to submit a new request to the Department of Health and Human Services (HHS) for an updated scientific and medical evaluation and scheduling recommendation for these substances. DEA is withdrawing the proposed rule and notice of hearing that was published in the Federal Register on July 6, 2022, and is canceling the public hearing and terminating the pending hearing proceedings. DEA may issue a new proposed rule in the future regarding these substances if warranted.”