The US Drug Enforcement Administration (DEA) has withdrawn its proposal to effectively ban five psychedelic compounds after receiving significant opposition from the research and advocacy community.
The DEA’s initial plan was to place the tryptamines 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET and DiPT on Schedule 1 of the Controlled Substances Act, putting them in the same category as heroin, cannabis and LSD. But the move generated so much pushback that the DEA scheduled a hearing for 22nd August.
It has now cancelled the hearing and withdrawn the proposal, pending further scientific evaluation.
“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,” it said.
It is not clear how long it will take HHS to conduct the review and there is no guarantee that it will translate into a permanent end to the ban. The DEA said it “may issue a new proposed rule in the future regarding these substances if warranted”. Nonetheless, it is an important indication of the levels of support for psychedelics research.
Mental health issues
Federal agencies have been under pressure to review the legal status of the substances for research purposes in recent months.
In May, US senators Brian Schatz and Cory Booker wrote to the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) outlining the challenges faced by researchers and calling for more support at federal level.
“Many major pharmaceutical companies have withdrawn or scaled back funding in this field because of the high rate of failure to find medications that are acceptable for FDA approval,” wrote the senators to NIH acting director Lawrence Tabak and FDA commissioner Robert Califf.
“Research on psilocybin for severe depression and anxiety-related disorders, as well as MDMA for PTSD, is currently being supported primarily by small organisations that do not have adequate funding to develop medications through expensive safety studies and large-scale phase 3 clinical trials.”
The Democratic senators requested written responses to their inquiries on the level of NIH funding into psychedelics for mental health treatments, collaboration between the FDA, NIH and private sectors, and a review of the regulatory barriers to research.
While the DEA has called for increased production quotas of cannabis and psilocybin for research purposes, its scheduling decisions have created barriers for scientists. The agency has been sued on a few counts, including over delays to producing public records on psychedelics and cannabis research and the right to give psilocybin to dying patients.
Past research could inform today’s
Considerable research into psychedelics was undertaken by US authorities in the 1950s and 1960s, as Schatz and Booker pointed outed in their letter.
“A US Drug Enforcement Agency (DEA) document reported that from about 1950 to 1965, ‘research on LSD and hallucinogens generated over 1,000 scientific papers, several dozen books, and six international conferences, and LSD was prescribed as treatment to over 400,000 patients’,” they wrote.
Schatz and Booker have requested a review of these studies, which could inform today’s research. And the demand for this is gaining momentum in response to the current rising number of mental health issues around the world.
“The wave of new research under way today is colouring psychedelics as more evidence-based and efficacious for serious mental health problems facing us today,” said Diane Scott, chairman and group CEO of the Jamaica Medical Cannabis Corporation. “I believe in time the psychedelics industry will become part of the legal medical industry, which must dictate the need for regulatory frameworks equal to all medical products, to ensure the quality, safety and soundness of the medicine for the patients who use it.”
– Lorraine Mullaney CBD-Intel staff
Artwork: Linnaea Mallette