DEA Withdraws Rule to Ban Five Psychedelics

BY MICHAEL BORCHARD
January 17, 2023 | | 6 min read

On July 22, 2022, the US Drug Enforcement Administration withdrew a proposed rule from January 14th to place five psychedelic drugs of the tryptamine class – 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT – in schedule I. This designation is the most restrictive a psychoactive chemical can have. The uncharacteristic withdrawal came in the wake of hundreds of public comments and several hearing requests from scientists and pharmaceutical companies. Intense backlash to the proposal seems to have caused the DEA to reconsider its original decision. The rule was based on a dated 2012 recommendation from the US Department of Health and Human Services, citing small-scale abuse and similarity to existing hallucinogens as adequate evidence to support scheduling. Even though the DEA admitted to needing “updated scientific and medical evaluation,” interested parties claim that this may signal a shift in the field of psychedelic research.1

Over the last decade, psychedelic substances have garnered fresh interest as important, possibly life-saving treatments for several different mood disorders, most notably depression, PTSD, and addiction. They’ve regained status as a legitimate field of inquiry, as the FDA recently granted psilocybin and MDMA ‘breakthrough therapy designation’ for resistant depression and PTSD, respectively. Additionally, interest from numerous pharmaceutical/therapeutics companies has caused the psychedelic market value to be projected at over $8 billion by 2028. As a result, public and private institutions alike are becoming increasingly involved in the field.

As more money flows into research and patenting, these institutions, such as the pharmaceutical company Compass Pathways, are looking beyond the ‘classical psychedelics’ – including psilocybin, MDMA, and mescaline – and examining compounds that are novel but similar. These synthetic compounds expand upon the tryptamine and phenethylamine cores that psilocybin and MDMA respectively contain, hopefully creating drugs with more desirable properties. A recent venture by Compass demonstrates this new exploration. In 2020, they formed a ‘sponsored research agreement’ with Jason Wallach, Ph.D. and St. Joseph’s University in Philadelphia to form the Discovery Center, which has since produced around 150 novel psychedelic compounds intended for use in mental health therapies. Many of these may potentially be patented and sold by Compass, which is just one of many institutions with the same goal.

With such notable progress being made, the scientific community is worried about more compounds being classified as schedule I because the label imposes harsh restrictions on who can conduct research on them and how. Federal law largely prohibits the government from funding research on schedule I compounds, in addition to requiring registration and approval by the DEA in order to work with these substances. According to the Controlled Substances Act of 1970, a drug in schedule I is one that has “no currently accepted medical use and a high potential for abuse”. Nearly 80 different compounds have been placed in schedule I since 2020, and with a relatively low bar of evidence needed to obtain this classification, as illustrated by the January 14 rule, the community is understandably worried.

It comes as no surprise then that players in the psychedelic industry have a vested interest against regulations that will limit the production and sale of psychoactive compounds – the DEA’s recently withdrawn rule being a prime example. Pushback from the industry and community included two other established companies, Tactogen and Mindstate Labs, which were directly involved in the rule withdrawal by the DEA. Both parties are interested in producing and testing new psychedelic drugs, most notably DiPT. The companies were prepared to testify against the new rule, expecting it would stifle research and development. A statement released from Tactogen states, “We hope the DEA will reconsider its practice of encumbering every psychedelic with the maximum possible regulatory restrictions”. As it stands, government regulation, especially by the DEA, is a significant hurdle to scientific and industrial progress in this field. 

Though the DEA has a reputation for imposing harsh regulations, this unexpected shift in action signals that the administration may be more willing to recognize psychedelics as legitimate pharmaceuticals. Indeed, the acting DEA Administrator in 2018 stated that “We are committed to finding new and innovative ways to meet the needs of the research community”.6 The current tension between government regulatory agencies and the pharmaceutical industry highlights the need for better communication and clarification of goals. The world of drug research is quickly evolving, and despite there being much work to be done, this marks a much-needed win in the pursuit of free inquiry, open access to information, and scientific progress.

References
  1. 45076 Federal Register /Vol. 87, No. 143/Wednesday, July 27, 2022 … 27 July 2022, https://www.govinfo.gov/content/pkg/FR-2022-07-27/pdf/2022-16102.pdf. 
  2. “Schedules of Controlled Substances: Placement of 4-Hydroxy-N,N-Diisopropyltryptamine, 5-Methoxy-Alpha-Methyltryptamine, 5-Methoxy-N-Methyl-N-Isopropyltryptamine, 5-Methoxy-N,N-Diethyltryptamine, and N,N-Diisopropyltryptamine in Schedule I.” Regulations.gov, 13 Jan. 2022, https://www.regulations.gov/document/DEA-2022-0001-0001.
  3. Marks, Mason, and I. Glenn Cohen. “Psychedelic Therapy: A Roadmap for Wider Acceptance and Utilization.” Nature Medicine, vol. 27, no. 10, 4 Oct. 2021, pp. 1669–1671., https://doi.org/10.1038/s41591-021-01530-3. 
  4. “Psychedelic Therapeutics Market Worth $ 8.31 Billion by 2028 – Exclusive Report by Insightace Analytic.” Bloomberg.com, Bloomberg, 18 July 2022, https://www.bloomberg.com/press-releases/2022-07-18/psychedelic-therapeutics-market-worth-8-31-billion-by-2028-exclusive-report-by-insightace-analytic. 
  5. Semley, John. “The High-Stakes Race to Engineer New Psychedelic Drugs.” Wired, Conde Nast, 26 July 2022, https://www.wired.com/story/race-to-engineer-new-psychedelic-drugs/. 
  6. “DEA Speeds up Application Process for Research on Schedule I Drugs.” DEA, 18 Jan. 2018, https://www.dea.gov/press-releases/2018/01/18/dea-speeds-application-process-research-schedule-i-drugs. 
  7. “Drug Scheduling.” DEA, 10 July 2018, https://www.dea.gov/drug-information/drug-scheduling. 
  8. “Scheduling Actions – Chronological Order – September 2022.” Deadiversion.usdoj.gov, Sept. 2022, https://www.deadiversion.usdoj.gov/schedules/orangebook/b_sched_chron.pdf. 
  9. “News.” Tactogen Inc, 26 July 2022, https://tactogen.com/news/#dea_withdraws.