Dave Hodes
When you see various agencies of the U.S. government getting involved in psychedelics, or changing their stance even a little (such as the DEA), that signals that the industry has hit its stride.
Avenues of development open up, investor confidence increases, and researchers sense the ability to achieve goals that not only science but government supports. It begins to feel like everyone is on the same page.
Here’s a look at what various government agencies are doing about psychedelics:
– DEA. The Drug Enforcement Administration seems to want to help the psychedelics industry more than ever, but can’t help adding caveats about what that progress looks like. For example, the DEA reported in the Federal Registry on October 18, 2021 that there has been a significant increase in the use of schedule I hallucinogenic controlled substances for research and clinical trial purposes (MDMA and psilocybin chief among them), and that it has approved new applications for schedule I research registrations and new applications for registration from manufacturers and corresponding quota applications to grow, synthesize, extract, and manufacture dosage forms containing specific schedule I hallucinogenic substances for clinical trial purposes. The DEA also reported that it supports increased production quotas proposed for 2022 compared with production quotas for these substances in 2021. That’s good news for the industry—followed by more bad news. On January 14, 2022, the DEA proposed placing five tryptamine hallucinogens(4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiP) on schedule I of the Controlled Substances Act. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on anyone who handles (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or proposes to handle these five specific controlled substances. That could be a problem for Field Trip, a psychedelics therapy company. “Field Trip’s FT-104 is a prodrug of 4-OH-DiPT, so this will add some paperwork and delays to their efforts in the U.S.,” Matt Baggott, co-founder and CEO of Tactogen, a pharmatech company, wrote in a tweet about the DEA news. “It’s worth noting that HHS provided DEA with an analysis of these compounds in 2012 and DEA failed to act until now. This raises the question of whether this scheduling is in response to the increased interest in psychedelic medicine.”
– FDA. Probably the most active government psychedelics supporter is the Food and Drug Administration because of the critical role it plays in assessing any drug that wants to be FDA-approved and sold to the public. The agency has picked up the pace in its work with psychedelics. But it is still charged with an exceptional sense of prudence when working to legitimize novel compounds. In a commentary published in the American Journal of Medicine in January, Attorney Matt Lamkin, associate professor at the University of Tulsa College of Law, discussed the role of the FDA as research into psychedelics explodes. “Incorporating psychedelic drugs into clinical practice will require peeling back multiple layers of legal prohibition, clarifying prescribing guidelines, and developing treatment models that work for drug makers, physicians, and payers.” He went on to cite various achievements of the FDA and psychedelics: granting breakthrough therapy status to expedite the development and review of multiple psychedelic drugs; approval in 2019 of esketamine as a therapy for treatment-resistant depression; the promising results from an FDA-approved phase 2 trial of psilocybin as a treatment for major depressive disorder; and in June, when researchers published results from a phase 3 trial—the final phase before seeking FDA approval—studying 3,4-methyl-enedioxymethamphetamine (MDMA) as a treatment for posttraumatic stress disorder. Still, Lamkin was cautious about how and what the FDA could do. “Although the psychedelic research revival is yielding promising results, challenges remain before these drugs will find their way into clinical practice. Yet this plodding process could enhance the likelihood that these therapies will actually take root,” Lamkin wrote. “Given the longstanding skepticism toward psychedelic interventions, moving too swiftly might risk a backlash that could further stall research. Proceeding both with caution and openness offers the best hope for harnessing the potential benefits of these drugs while mitigating their risks.”
– NAS. The National Academies of Science, Engineering and Medicine is focusing more attention on the psychedelics arena. For example, on March 29, the NAS will be conducting a workshop exploring psychedelics and entactogens as treatments for psychiatric disorders. The NAS noted on its website about the workshop that, with activity and interest in this field continuing to grow, the workshop “will provide a venue to explore strategies for harnessing the potential of these agents to combat mental illness.” Invited speakers will discuss the neurobiology of the therapeutic effects, strategies for optimizing the safety, efficacy, and patient stratification, and lessons learned that may help the identification of new classes of therapeutic agents. The workshop will explore the unique challenges and considerations presented by compounds that induce profound changes in consciousness, including those related to clinical trial design, medical ethics, and the psychosocial contexts of drug administration. The workshop is sponsored by the Department of Health and Human Services and the National Science Foundation.
– NIH. The National Institutes of Health discussed psychedelics favorably at the National Institutes of Health’s FY22 Budget and the State of Medical Research hearing before the Subcommittee on Labor, Health and Human Services Education and Related Agencies on May 26, 2021. “I think as we’ve learned more about how the brain works we began to realize that these are potential tools for research purposes and might be clinically beneficial,” Francis Collins, director of the NIH said, referring to psychedelics such as psilocybin and MDMA. Collins said there has been a resurgence of interest in psychedelic drugs, which for a while “were sort of considered not an area that researchers legitimately ought to go after.” Additionally, on October 20, 2021, Johns Hopkins Medicine announced that the National Institute on Drug Abuse (NIDA) within the NIH, had awarded a grant of $4 million to fund a study using psilocybin as a therapeutic agent for smoking cessation. It is the first grant awarded by the United States government for research on psilocybin for tobacco use in 50 years. The multi-site, three-year study will be led by researchers with Johns Hopkins Medicine in collaboration with researchers at the University of Alabama at Birmingham.
– NSF. The National Science Foundation is stepping up its support of psychedelics studies. One example is a study on how psilocybin and LSD work on brain activity, funded in part by an NSF grant for a six year study of various interdisciplinary training elements for complex networks and systems.
–USDA. The U.S. Department of Agriculture is on the lookout for ketamine. According to a Consumer Reports analysis of data from the Food Safety and Inspection Service, a branch of the U.S. Department of Agriculture, trace amounts of ketamine may have appeared in the U.S. meat supply more often than was previously known, pointing to new testing technologies that can better show what’s in meat today. The data for Consumer Report’s assertion came from the USDA’s Food Safety and Inspection Service (FSIS), the agency responsible for ensuring the safety of the U.S. meat supply. Emilio Esteban, chief scientist for the FSIS, said that the results should be discounted because they came from unconfirmed screening tests. “These results are credible enough that you would expect the government to take the warning signs seriously,” says James E. Rogers, Ph.D., who was a microbiologist at the FSIS for 13 years before becoming director of food safety research and testing at Consumer Reports. “You would hope the results would prompt the agency to look into why these drugs may be present, what risks they could pose, and what could be done to protect consumers.”
