Politics
Researchers Ask Federal Court To Block DEA From Banning Two Psychedelics Under ‘Unconstitutional’ Administrative Process
Researchers are asking a federal court to block the Drug Enforcement Administration (DEA) 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) filed a complaint and request for injunctive relief against DEA in the U.S. District Court for the Western District of Washington last week.
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 (CSA).
The filing doesn’t 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 DEA’s reliance on administrative law judges (ALJs) to settle such arbitration is unconstitutional based on U.S. Supreme Court precedent.
PPS said that because the Supreme Court has held that ALJs are considered “inferior officers,” current statutory removal protections unconstitutionally insulate them from executive control under Article II of the Constitution. That means DEA should not be permitted to subject researchers to an administrative hearing concerning the psychedelic scheduling proposal, the filing says.
“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.”
“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.”
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 (MSPB).
“This degree of insulation is unconstitutional,” PPS said. “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 says. “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.”
“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 argued that separate Supreme Court precedent means it does not have to wait for the outcome of DEA’s administrative hearing to challenge the constitutionality of the process, as subjecting the complainants to that process in and of itself would 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 1) affirm the unconstitutionality of DEA’s ALJ policies, 2) impose a temporary restraining order blocking the agency from moving forward with the DOC and DOI scheduling process, 3) provide temporary and permanent injunctive relief staying DEA’s administrative adjudicative and regulatory proceedings in the case and 4) requiring the agency to withdraw its scheduling proposal until the constitutional issues are resolved.
This is the latest development in a years-long dispute over DEA’s efforts to schedule the psychedelics, which it first attempted to do in 2022, only to withdraw the proposal amid pushback from the scientific community. The agency separately withdrew from a proposal to ban five different tryptamine psychedelics in 2022.
Last December, 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 demonstrated a high abuse potential.
“To date, there are no reports of distressing responses or death associated with DOI in medical literature,” it says. “The physiological dependence liability of DOI and DOC in animals and humans is not reported in scientific and medical literature.”
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.”
It did point 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 reason enough to place them in the most strictly controlled schedule.
Meanwhile, DEA is also under significant public and political pressure to complete its review into marijuana scheduling after the agency received a recommendation to move cannabis to Schedule III of the CSA from the U.S. Department of Health and Human Services (HHS).
The head of the Food and Drug Administration (FDA) under HHS told congressional lawmakers last week 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 also discussed the marijuana actions in a historic context last month, during his State of the Union address.
Vice President Kamala Harris also urged 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 DEA to complete its analysis of health officials’ scheduling recommendations—which is just about how long it has now been since the agency began its current cannabis assessment.
Meanwhile, last month, 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 their decision.
Certain DEA officials are reportedly resisting the Biden administration’s rescheduling push, disputing the HHS findings on marijuana’s safety profile and medical potential, according to unnamed sources who spoke with The Wall Street Journal.
Read the federal court filing in the DEA psychedelics scheduling matter below:
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