Those betting on a cannabis rescheduling recommendation ahead of the midterm elections may be down on their luck after the judge responsible for making that recommendation issued a stay amid new findings.
Derek C. Julius, the Drug Enforcement Administration’s (DEA) administrative law judge, granted the stay on Sept. 29 at the request of three anti-rescheduling parties that participated in the hearing process this summer to debate the merits of the Department of Justice’s (DOJ) proposed rule to loosen restrictions on cannabis by reclassifying it as a Schedule III drug under the Controlled Substances Act (CSA).
Julius, who oversaw the 11-day hearing that concluded on July 15, was expected to make his nonbinding recommendation to DEA Administrator Terry Cole after releasing more than 2,500 pages of transcripts from the hearing’s proceedings on Aug. 25. While there is no set timeline for the judge to fulfill this statutory duty, many believed he would do so before the 2026 midterms.
But what was expected to be the last step in the hearing process is now on pause after Julius granted DUID Victim Voices, Kenneth Finn, M.D., and the National Drug and Alcohol Association (NDASA) – three of seven anti-rescheduling parties that participated in the hearing process – their request for a stay in the case.
The three parties requested the stay based on new findings from a report that the DEA’s drug scheduling policies have “gaps.” The nonpartisan U.S. Government Accountability Office (GAO) released the report on Sept. 23.
The report is entitled “Drug Scheduling: While DEA Decisions Have Aligned with Recent HHS Recommendations, Both Need Comprehensive Policies.”
“DEA does not have policies that identify roles, responsibilities and procedures related to scheduling,” the GAO found. “[The U.S. Food and Drug Administration] does not have policies or procedures specifying how its staff are to conduct evaluations or develop recommendations. Developing such policies and procedures could help ensure operational consistency, especially if key personnel with longstanding subject matter expertise depart.”
The report relates to the genesis of the cannabis rescheduling proposed rule, which former U.S. Attorney General Merrick Garland signed off on in 2024 after the FDA conducted an eight-factor analysis to determine the plant’s appropriate control status under the CSA as part of a 10-month scientific and medical evaluation.
Following the evaluation, the U.S. Department of Health and Human Services (HHS), which umbrellas the FDA, made its formal recommendation to the DOJ.
The DOJ, through the DEA, typically conducts its own eight-factor analysis before making a final rescheduling decision; however, DEA pharmacologist Luli Akinfiresoye said the DEA did not do so before the DOJ published its notice of proposed rulemaking (NPRM) in the Federal Register in May 2024.
Akinfiresoye testified under a subpoena as an expert witness for prohibitionist group Smart Approaches to Marijuana (SAM) during the cannabis rescheduling hearing in July.
Akinfiresoye said that she and her colleagues at the Drug and Chemical Evaluation Section conducted their own unofficial eight-factor analysis and submitted their findings in a December 2024 “scientific document” titled “Marijuana: Scientific Knowledge.” She said they did so because the May 2024 notice of proposed rulemaking “had gaps in data.”
“Ideally, when we publish an NPRM, we also publish an eight-factor analysis,” she said during her testimony. “In this case, that did not happen because one was not done.”
In last week’s GAO report, the government watchdog agency made three recommendations, including one for the DEA.
“The administrator of DEA should develop policies and procedures that identify DEA’s roles, responsibilities and procedures for evaluating and scheduling substances through administrative scheduling, new drug application scheduling, temporary scheduling and international treaty scheduling under relevant statutes (including collecting and evaluating data, conducting three-factor and eight-factor analyses, and determining scheduling decisions).”
This report piqued Julius’ interest enough to halt the entire rescheduling hearing process, which was otherwise wrapped up pending his recommendation. The three parties who requested the stay asked the judge to include the GAO report in the official administrative record.
“The motion further requests an additional briefing period on the contents of the GAO report and how it impacts these proceedings, if at all,” Julius wrote in Tuesday’s order. “Finally, the motion requests a brief stay to allow time for these matters to develop.
“The three interested parties in the instant motion have requested that this tribunal ‘hold its recommended decision and certification of the record’ if and until briefing is completed on the GAO report. This tribunal finds merit in this argument that, if the record were to be extended to also include the GAO report, a stay would be warranted to await briefing on it. Likewise, while considering the merits of the instant motion to add the GAO report to the record and allow supplemental briefing, a stay is warranted for the same reasons.”
The judge ordered the DEA to file a response to the motion no later than Oct. 13, adding that the response should be no longer than 20 pages. He’s also allowing, but not requiring, the four remaining parties that participated in the hearing to file responses.
“Accordingly, based on the nature [of] this motion, it is ORDERED that this matter is STAYED pending the motion’s resolution,” Julius wrote.
