We Fought the DEA in Their Own Court — For Science!
This article was written by
Written by:
Alaina M. Jaster, PhD
Postdoctoral Scholar, Wayne State University
Co-founder, Psychedelic Brain Science Podcast
Member, SSDP Science Policy Committee
Elijah Z. Ullman, PhD
Post-doctoral Research Fellow | Emory University
Chair, SSDP Science Policy Committee
The second floor of a generally unassuming building was full of activity on average Tuesday, as the SSDP/Ramos team went through security and settled into the Drug Enforcement Agency (DEA) headquarters administrative courtroom. Over the following seven business days, the DEA Administrative Law Judge, Paul E. Soeffing, heard evidence from SSDP/Ramos regarding the proposed placement of 2,5-dimethoxy-4-iodo-amphetamine (DOI) and 2,5-dimethoxy-4-chloro-amphetamine (DOC) in Schedule I of the Controlled Substances Act. This hearing was historic as it was the first time in nearly 40 years that psychedelic pharmacology was on trial with the DEA and that ‘harms to research’ could be discussed in the context of drug scheduling within the Controlled Substances Act.
The two parties who filed for a hearing were SSDP, represented by SSDP General Counsel Brett Phelps, Esq., and Dr. Raul Ramos from UC Berkeley, represented by Robert Rush, Esq. Shortly after both parties had filed, we began to work together.
The DEA first tried placing these two drugs in Schedule I in 2022 but withdrew this proposed ruling due to administrative reasons. They renewed their efforts in December 2023 when the SSDP Science Policy Committee (SPC) filed a request for a hearing for the second time. To better understand what went on these last few weeks, we aim to give the what, why, and how from two party signatories that were along for the ride. For brevity’s sake, we will focus mainly on DOI, as this is more commonly used in research labs.
The What
DOI and DOC are the most widely used, best available agonists, or activators, of the serotonin 2 type receptors, specifically serotonin 2A and 2C (5-HT2A & 5-HT2C) receptors. These receptors may sound familiar as they are the primary targets of psychedelic drugs. However, they are involved in much more than psychedelic drug activity and are the most widely expressed serotonin receptors in the brain. Serotonin is responsible for various behavioral modulations including changes in appetite, mood, hormone regulation, inflammation, and more. The specificity of DOI at the 5-HT2A receptor, combined with its unscheduled status, gives scientists a fantastic and easily accessible tool to study a variety of behaviors and conditions related to serotonin signaling at the 5HT2 receptor. These studies can help inform novel treatments for various neuropsychiatric disorders.
The Why
These psychedelics have been used in thousands of published, peer-reviewed journal articles over the last 50 years. This is because they are not scheduled under the Controlled Substances Act, allowing researchers to access them without barriers. The availability of DOI has made psychedelic research accessible to the scientific community; it allows scientists to utilize it as a tool to understand a variety of topics in neuroscience, including things like pain, inflammation and more. If these substances were scheduled, many laboratories would possibly abandon novel and exploratory research due to the lengthy and onerous approval process. Many researchers testified during the hearing that the process to obtain schedule I licensure takes “at least a year,” highlighting that in addition to the filing with the DEA, there is preparatory paperwork, institutional hurdles, and in some cases, state requirements. Due to these difficulties in applying for a license, many research groups choose not to work with Schedule I substances, thus reducing the understanding of these serotonin-related brain functions.
In addition to the potential research harms, these psychedelics are rarely used recreationally. These compounds are unique in that their characteristics are unlike other substances. For example, they have a long onset, an extraordinarily long duration of action – roughly 20 to 36 hours in humans –, and their peak effect is not easily discerned. These characteristics, combined with their anecdotally noted “unpleasant” psychedelic effects, make them not popular among recreational users. Interestingly, these very factors that make it unpopular in people are what make them excellent research tools for understanding the involvement of those 5-HT2 receptors.
Further, scheduling these compounds is unnecessary due to The Analogs Act. This act was passed, in essence, so the DEA would not need to place every single drug in the Controlled Substances Act, and prosecutors have a way to control novel psychoactive substances similar to other scheduled substances if they are deemed a public health concern. This act also preserves research access for scientists since these analog substances may not be scheduled, they do not need to seek the multi-level approvals to work with them.
The How
All branches of the Federal Government work for the people of the United States, therefore when an Executive Branch agency such as the DEA proposes to place a drug on the Controlled Substances Act, it does so through a Notice of Proposed Rulemaking, a process outlined in the Administrative Procedures Act. Citizens can make public comments on the Federal Register for Agency consideration during rulemaking and request a Hearing on the matter. An Administrative Law Judge, which is a particular type of judge who presides over hearings related to a specific Executive Branch agency, has the authority to grant interested parties a hearing on that rule-making if the judge believes that person or organization has relevant standing and may be legally injured if the rule were formalized.
The SPC was created to bridge the gap between science and policy decisions. Many of the members work on the pharmacology and neuroscience of psychedelics and had many concerns with this proposed ruling. We believed that because our members use DOI and DOC in their scientific research, placing these drugs on Schedule I of the Controlled Substances Act would substantially harm their research efforts. We, therefore, filed for a hearing on this matter, pursuant to 21 CFR 1308.44, to argue that these two drugs should not be placed in Schedule I of the CSA due to their importance in research and lack of any evidence of use or diversion.
The SPC comprises scientists from various training levels, including PhD students and postdoctoral researchers. However, it is important to note that any American citizen can file for a hearing and directly interface with and participate in democracy with Executive Branch agencies.
What it Was Like at DEA HQ
For decades, the DEA has been able to place whatever drug it wanted on the CSA, with little formal opposition from the scientific community. This was the first time in nearly 40 years that the pharmacology and epidemiology of psychedelics were argued over in court with the DEA. Previously, a hearing was granted when MDMA was ordered to be placed in Schedule I in 1985. Our hearing was in an unassuming building, off a highway interchange near Washington DC, with extensive security and bright blue carpet, with explicit instruction that no photos would be taken inside.
Many government employees and attorneys were coming to watch the hearing every day, highlighting that they had “never seen something like this.” Whether they were referring to the hearing itself or the unprecedented length of the hearing is unknown. Despite this heightened attention, the dichotomy between the DEA and SSDP/Ramos’ beliefs was wholly apparent. For one, when Dr. Theresa Carbonaro, the DEA expert witness and pharmacologist, was asked if drug use equates to abuse, DEA employees shouted out from the audience, “YES!” Despite the ever changing landscape and science of how we understand substance use, the DEA has remained behind other organizations, such as the National Institute of Drug Abuse, who are changing their name to the National Institute on Drugs and Addiction in recognition that all use is not abuse.
Another prime example of these philosophical differences was when Dr. Alaina Jaster was on the stand. The government had opened a line of questioning related to Jaster’s personal beliefs on drug criminalization in reference to posts she had made online, asking her whether or not she believed that all drugs should be legal. Jaster responded with stoic indifference that “Yes,” she believes all drugs should be legal. Later during redirect with attorney Brett Phelps, Jaster elaborated on the harms of criminalization and the need for more harm reduction based policies. This testimony was at great odds with the DEA’s own stated goals that by “bringing drugs into the closed system, they can prevent diversion and harm to public health while providing safe access to medical treatments.”
Common Ground
While the DEA and SSDP/Ramos did not agree on much of the evidence presented, they did agree to a specific set of facts:
- There is no diversion of DOI or DOC from legitimate channels, including research laboratories.
- There is no evidence of physiological or psychic dependence of DOI and DOC.
- There is no documentation in medical literature on the human use of DOI, including no reports of distressing responses or death associated with DOI.
- It is impossible to know if anecdotal reports of people taking or selling the substances are true without analytical confirmation.
Despite the many arguments, objections, high tensions, and yes – some laughs – the ALJ remained attentive and impartial. His recommendation will come following a review of the courtroom transcripts and submission of the post-hearing briefs from both SSDP/Ramos and the Government. This is estimated to take several months.
Reflections from Dr. Elijah Ullman, chair of the SSDP SPC
The entire endeavor, stretching back to first filing the hearing request in January 2024, felt like we were building the ship as we were sailing it. Every single member of the SPC worked as equals, and our attorneys, Brett Phelps and Robert Rush saw us as equals, where we were learning as much about law as they were about science.
Filing for a hearing on drug scheduling with the DEA never felt scary. We had a sense of purpose and obligation to protect access to DOI and DOC for research. I also had the best go-to partner in Dr. Jaster, who felt just as passionate about this work. Our entire team worked as hard as they could on this. As we built our proposed witness list with some of the world’s foremost experts on psychedelics, I could feel our group’s excitement grow and the sense that we had a real shot of making an exceptional argument to the court.
None of us were experts on Administrative Hearings, we were just a couple of passionate scientists who wanted to make a difference. Now our group has gone up in front of the Federal Government and made our voices heard. Students should not be afraid to challenge proposed rulings or be involved in their government. You’ll find a way to make it all work with the right team. It’s important to bring truth to ‘America: ruled by the people, for the people’.
