LSD blotter paper
Researchers are asking a federal court to block the Drug Enforcement Administration from proceeding in its attempt to ban two psychedelics, arguing that the agency’s administrative approach to the proposed scheduling is unconstitutional.
Panacea Plant Sciences (PPS), a psychedelic research company, filed a complaint and request for injunctive relief against the DEA in the United States District Court for the Western District of Washington on April 10.
The legal challenge focuses on the agency’s recent scheduling of an administrative hearing to receive expert input on its controversial plans to classify 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) as Schedule I drugs, under the Controlled Substances Act.
The filing doesn’t primarily speak to the merits of the scheduling proposal—an issue that psychedelics researchers have previously addressed in public comment. Rather, PPS is contesting the administrative hearing process that’s preceding final rulemaking, arguing that the DEA’s reliance on administrative law judges (ALJ) to settle such arbitration is unconstitutional based on US Supreme Court precedent.
PPS argues that because the Supreme Court has held that ALJ are considered “inferior officers,” current statutory removal protections unconstitutionally insulate them from executive control under Article II of the Constitution. That means the DEA should not be permitted to subject researchers to an administrative hearing concerning the psychedelic scheduling proposal, according to the filing.
“The hearing and scheduling poses a significant threat to the company,” it says. “PPS conducts research and development on medical technologies which include the use of DOI or DOC for development and as products themselves. Currently, DOI and DOC are not controlled.”
“Removing access to these compounds through legal channels and/or making their access more difficult would severely limit science.”
“Under the Controlled Substances Act (CSA) and its implementing regulations, PPS will be required to turn over to law enforcement or destroy our stock of DOI and DOC which means the rule-making acts as an effective taking of property,” the document says.
“As a result, when PPS received the hearing notice from DEA, it was faced with a stark choice: either default and lose automatically or defend itself against the DEA’s attempts to schedule DOI and DOC and its use of an ALJ-overseen adjudication,” it continues. “PPS is thus compelled to participate in the DEA’s adjudicatory proceedings.”
The DEA doesn’t have authority to adjudicate the scheduling question based on this administrative process because ALJs continue to enjoy statutory removal protections, the complaint says. That is, there are current requirements that the judges can only be removed for “good cause,” as “determined” by the Merit Systems Protection Board.
“This degree of insulation is unconstitutional,” PPS contends. “Indeed, because DEA ALJs do not satisfy either narrow recognized exception to the President’s unrestricted removal power, any degree of insulation is unconstitutional.”
“The DEA’s scheduling hearings has stakes that extend beyond PPS,” it adds. “DOI and DOC are widely used in research and development for pharmaceutical drugs related to the mind and other bodily systems. They are also key compounds for the research into schizophrenia and other related illnesses.”
This is the latest development in a years-long dispute over the DEA’s efforts to schedule the psychedelics.
“Removing access to these compounds through legal channels and/or making their access more difficult would severely limit science and reduce the reproducibility of experiments and ability to compare to past research. This would lead to reduced development of new treatments and less understanding of medical conditions, which could lead to increased deaths and suffering in the United States and beyond over time.”
PPS further argues that separate Supreme Court precedent means it does not have to wait for the outcome of the DEA’s administrative hearing to challenge the constitutionality of the process, as subjecting the complainants to that process would in and of itself constitute “an independent, immediate, ‘here-and-now’ injury—one that cannot be remedied through normal channels of appeal.”
Therefore, PPS is asking the federal district court to: Affirm the unconstitutionality of DEA’s ALJ policies; impose a temporary restraining order blocking the agency from moving forward with the DOC and DOI scheduling process; provide temporary and permanent injunctive relief staying the DEA’s administrative adjudicative and regulatory proceedings in the case; and require the agency to withdraw its scheduling proposal until the constitutional issues are resolved.
This is the latest development in a years-long dispute over the DEA’s efforts to schedule the psychedelics. It first attempted to do so in 2022, only to withdraw the proposal amid pushback from the scientific community. The agency separately withdrew a proposal to ban five different tryptamine psychedelics in 2022.
The DEA said anecdotal reports signaled the substances have hallucinogenic effects, making it “reasonable to assume that DOI and DOC have substantial capability to be a hazard.”
In December 2023, the DEA announced that it would be trying to enact the DOC and DOI ban again. The agency’s notice about the scheduling proposal still lacks evidence that directly connects the compounds to serious adverse health events or demonstrates high “abuse” potential.
“To date, there are no reports of distressing responses or death associated with DOI in medical literature,” the notice said. “The physiological dependence liability of DOI and DOC in animals and humans is not reported in scientific and medical literature.”
But the DEA said that anecdotal reports posted by people online signaled that the substances have hallucinogenic effects, making it “reasonable to assume that DOI and DOC have substantial capability to be a hazard to the health of the user and to the safety of the community.”
The agency pointed to one report of a death of a person who had used DOC in combination with two other unspecified drugs, as well as two reports of hospitalizations that it said were attributable to the use of DOC with other drugs. But scientists say that hardly constitutes adequate reason to place DOC and DOI in the most strictly controlled schedule.
Meanwhile, the DEA is also under significant public and political pressure to complete its review into marijuana scheduling, after the agency received a recommendation from the US Department of Health and Human Services (HHS) to move cannabis to Schedule III of the CSA.
The head of the Food and Drug Administration (FDA) under HHS told congressional lawmakers earlier in April that there’s “no reason” for DEA to “delay” making a marijuana scheduling decision.
FDA Commissioner Robert Califf’s comments came as the Biden administration continues to tout its role in issuing cannabis pardons and directing the marijuana scheduling review, including in a presidential proclamation declaring April “Second Chance Month.”
President Joe Biden discussed the marijuana actions in a historic context in March, during his State of the Union address.
Certain DEA officials are reportedly resisting the Biden administration’s rescheduling push, disputing HHS findings on the safety profile and medical potential of cannabis.
Vice President Kamala Harris also urged the DEA to finish its review and reschedule marijuana “as quickly as possible” while meeting pardon recipients for a roundtable event at the White House last month. Behind closed doors, she also said “we need to legalize marijuana.”
A DEA official recently said it sometimes takes up to six months for the agency to complete its analysis of health officials’ scheduling recommendations—which is just about how long it has now been since its current cannabis assessment began.
In March, HHS Secretary Xavier Becerra defended his agency’s rescheduling recommendation during a Senate committee hearing, and also told cannabis lobbyist Don Murphy that he should pay DEA a visit and “knock on their door” for answers about the timing of the decision.
Certain DEA officials are reportedly resisting the Biden administration’s rescheduling push, disputing the HHS findings on the safety profile and medical potential of cannabis, according to unnamed sources who spoke with the Wall Street Journal.
Photograph via the Drug Enforcement Administration
This story was originally published by Marijuana Moment, which tracks the politics and policy of cannabis and drugs. Follow Marijuana Moment on Twitter and Facebook, and sign up for its newsletter.