Inept efforts by the DEA to assign two psychedelic drugs to Schedule I of the Controlled Substances Act have backfired thanks to a granted request for a restraining order that stalls the scheduling process for 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC).
In addition to the scheduling controversy, DEA Administrative Law Judge (ALJ) Paul E. Soeffing has cordially acknowledged a challenge to the legal authority of his court in a constitutional test of the ALJ process itself. The lawsuit filed by Panacea Plant Sciences, Inc. (PPS), a company researching DOI/DOC and related compounds, argues that DEA ALJs lack the legal authority to override a President’s implementation of policies encouraging research on medicinal applications of psychedelic drugs:
On April 8, 2024, PPS filed a motion in the DEA ALJ proceedings to request: a) the ALJ/judge to issue an injunction against the DEA to stop the rule-making due to errors/violations under the Administrative Procedure Act, Regulatory Flexibility Act and Tribal Consultation Executive Orders, b) a stay of the proceedings and halt to all Drug Enforcement Administration activity on rulemaking regarding DOI and DOC … and c) an impending challenge to the constitutionality of the DEA ALJ process. […]
9. The hearing and scheduling poses a significant threat to the company. 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.
10. Under the Controlled Substances Act 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.
11. 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. PPS is thus compelled to participate in the DEA’s adjudicatory proceedings. […]
12. That does not mean the ALJ proceedings should go forward. Under binding precedent, those proceedings violate Article II of the Constitution of the United States. As the Fifth Circuit held in Jarkesy v. SEC, 34 F.4th 446 (5th Cir. 2022), the two-layer, for-cause removal restrictions applicable to ALJs impermissibly impair the President’s constitutional charge to take care that the laws are faithfully executed. The same restrictions on for-cause removal at issue in Jarkesy are at issue here. Specifically, Sections 7521(a) and 1202(d) of Title 5 of the United States Code prevent the President and Attorney General from removing DEA ALJs unconditionally. Rather, ALJs may be removed only for “good cause” as “determined” by the Merit Systems Protection Board (“MSPB”), whose members themselves can be removed by the President only on certain limited “good cause” grounds. This degree of insulation is unconstitutional. Indeed, because DEA ALJs do not satisfy either narrow recognized exception to the President’s unrestricted removal power, any degree of insulation is unconstitutional.
13. The DEA’s scheduling hearings has stakes that extend beyond PPS. 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. In addition, the unconstitutional taking of property by the government without access to an Article III court would set an illegal, and dangerous precedent. […]
Should Panacea Plant Sciences’ lawsuit prevail we could finally see an end to the offices or functions of the DEA Administrative Law Judge as well as any further DEA interference in the drug scheduling process. We might even see the beginnings of an American judicial system which recognizes that science-based remedies save the sick, not words.