The cannabis rescheduling process will remain on hold until at least Nov. 5, after the Drug Enforcement Administration’s (DEA) chief administrative law judge granted one prohibitionist motion and denied another.
Judge Derek C. Julius, who holds the gavel over the matter, issued his order on Oct. 22, deciding he’ll allow a recent U.S. Government Accountability Office (GAO) report, as well as written legal arguments on the report, to be included in the administrative record; however, he will not reopen the hearing process to allow new testimony and evidence related to the report.
He ordered that the DEA and seven anti-rescheduling parties that participated in the 11-day rescheduling hearing that concluded July 15 to submit their optional briefs no later than Oct. 29, with any reply briefs to be submitted no later than Nov. 5.
“The briefs should be narrowly tailored to the issues of (1) the weight, if any, the tribunal should give to the GAO report; and (2) if it should be afforded weight, to what extent the GAO report has an effect on the current rescheduling matter (i.e., are the ‘gaps’ in written rescheduling policies identified by the GAO report substantial enough to jeopardize the larger process and specifically impact the instant rescheduling proposal before the tribunal),” Julius wrote in Thursday’s public order.
The GAO report, released on Sept. 23, found the DEA’s drug scheduling policies have “gaps” that fail to identify agency roles, responsibilities and procedures related to scheduling – but not gaps in the actual rescheduling analysis. The report’s issuance came more than two months after the DEA and seven anti-rescheduling parties debated the merits of a proposed rule to loosen restrictions on cannabis by reclassifying it as a Schedule III drug under the Controlled Substances Act (CSA) during an 11-day rescheduling hearing that concluded July 15.
Since the GAO report’s issuance, three of the anti-rescheduling parties – DUID Victim Voices, Kenneth Finn, M.D., and the National Drug and Alcohol Association (NDASA) – have argued that the report could provide significant evidence to back their position that cannabis should remain listed in Schedule I.
The DEA has since rejected the report’s weight, arguing that it’s “immaterial to the actual scientific processes and analysis” that it and the U.S. Food and Drug Administration (FDA) use in scheduling controlled substances.
Julius weighed in.
“Indeed, the moving parties and the government appear closer aligned in their understanding of the GAO report than their postures may indicate,” the judge wrote. “The division stems from the bearing the GAO report has on the present rescheduling matter; therefore, it is more an issue of weight and impact on this specific case.”
Specifically for the proposed Schedule III rule for cannabis, the FDA – under the umbrella of the U.S. Department of Health and Human Services (HHS) – conducted a 10-month scientific and medical evaluation in 2023, utilizing a two-part test to determine that cannabis has currently accepted medical use (CAMU) in the U.S. and therefore cannot remain listed in Schedule I. The FDA also conducted an eight-factor analysis to determine that cannabis best fits in Schedule III.
After the anti-rescheduling parties scrutinized that government process during the summer hearing, the three “moving parties” attempted to use the new GAO report as fuel to drag out the process in their favor, submitting five requests for documents and testimony earlier this month:
- the identities of all persons who were involved in the selection, recommendation or drafting of the two-part CAMU test and why the test was adopted;
- the identities of all persons who drafted the CAMU language in the HHS recommendation and the role various agencies and outside groups played in HHS’s recommendation drafting;
- an explanation for why the HHS evaluation submitted in this matter differed from HHS’s prior cannabis evaluations;
- criteria FDA used to assess the abuse potential and Schedule III comparisons; and
- the materials GAO reviewed and requested relative to all scheduling matters from any person, entity or group over the past six years.
Julius explained why he rejected the three anti-rescheduling parties’ motion to reopen the hearing, determining that the first two requests were “immaterial” for the narrow purpose of the hearing.
“It is undisputed that HHS employed the two-part test in its 2023 evaluation of marijuana,” the judge wrote. “The genesis of that test is not an essential question before this tribunal; rather, the deference the tribunal should afford the two-part test is an essential question. In fact, I indicated as much on the record when I directed the government to brief the issue of whether the [2024 Office of Legal Counsel’s] opinion, which determined that significant deference should be afforded to the two-part test, was binding on the tribunal.
“I also invited all other parties to weigh in on the issue. From my review of the post-hearing briefs, only the government and NDASA briefed that issue. Accordingly, the moving parties are not entitled to a reopened hearing on questions 1 and 2 when they were already allowed ample opportunity to explore those issues in their relevant forms.”
Julius also determined that the anti-rescheduling parties could have explored the third and fourth requests listed above during their cross-examinations of DEA expert witness Dominic Chiapperino, Ph.D., the director of the FDA’s controlled substances staff within the Center for Drug Evaluation and Research.
The three anti-rescheduling parties argued this week that they never got a “first bite” at the apple with Chiapperino, whose testimony was bound to topics included in the FDA’s Touhy letter. Julius said in the Oct. 22 order that his rulings during the summer’s hearing regarding the scope of Chiapperino’s Touhy letter stand, and the parties remain free to challenge the Touhy restrictions “to a court of competent jurisdiction.”
The judge said the fifth and final request was the strongest on which the moving parties relied as grounds to reopen the hearing.
“Nonetheless, this issue is also not before the tribunal, and allowing testimony on it would only serve to confuse the matter,” Julius wrote. “The GAO is not a party to this litigation, and the GAO report speaks for itself regarding its conclusions on the general rescheduling process and documentation about that process. Now that the GAO report is a part of the record, no further testimony is required concerning it.”
Julius also reiterated that the DEA, as the lone proponent of the proposed rule in the hearing process, carries the burden of proving that cannabis has currently accepted medical use in the U.S. and best fits within a Schedule III listing.
“If the moving parties now believe the record is ‘bare where it counts,’ … that argument goes towards the ultimate question of whether the government met its burden – it does not justify reopening the hearing, which already includes over 2,500 pages of witness testimony and multiple thousands of pages of documentary evidence.”
Once the interested parties submit their Oct. 29 briefs and Nov. 5 reply briefs, Julius still has the task of certifying the record and making his nonbinding scheduling recommendation to DEA Administrator Terry Cole.
The judge said any further briefings beyond Nov. 5 are “disfavored.”
