The Drug Enforcement Administration (DEA) told an administrative law judge on Oct. 20 to reject an anti-rescheduling request to reopen the cannabis hearing process because prohibitionists are not entitled to a “second bite at the apple.”
The 11-day hearing was held June 29 to July 15, when seven anti-rescheduling parties debated the DEA on 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).
DEA Administrative Law Judge Derek C. Julius, who oversaw the hearing, was expected to certify the record and make his nonbinding scheduling recommendation to DEA Administrator Terry Cole as soon as September. Instead, the judge halted the rescheduling process by granting a stay on Sept. 29 at the request of three anti-rescheduling parties that participated in the hearing.
The entire process is now delayed over a U.S. Government Accountability Office (GAO) report released on Sept. 23, which found the DEA’s drug scheduling policies have “gaps” that fail to identify agency roles, responsibilities and procedures related to scheduling.
The three anti-rescheduling parties – DUID Victim Voices, Kenneth Finn, M.D., and the National Drug and Alcohol Association (NDASA) – believe this report should be included in the administrative record and warrants further delay in the rescheduling process so hearing participants can offer new testimony and document discovery.
The DEA filed an initial response on Oct. 9, arguing that the GAO report “has no bearing on the ultimate issue of whether marijuana should be transferred to Schedule III,” leaving it up to Julius on whether to include the report in the administrative record while opposing the prohibitionist request to allow participants to submit additional documents/legal arguments related to the report.
Julius subsequently ordered the DEA to file a second response – the one the agency filed on Oct. 20 – after the three anti-rescheduling parties asked the judge to also reopen the hearing for additional testimony and document discovery on the GAO report.
The DEA’s Oct. 20 response was first reported by Marijuana Moment.
“Movants argue that their disagreement with the government’s interpretation [of the GAO report] creates a material issue of fact that this court must resolve by allowing movants to engage in broad, general written discovery, witness depositions and further briefing to the tribunal during a stay implemented until they have concluded their discovery process,” DEA argued in the Oct. 20 response. “This is an obvious fishing expedition based on a report that is clear on its face.”
From the DEA’s position, the GAO report and recommendation are “immaterial” to the scientific processes and analyses the DEA and U.S. Food and Drug Administration (FDA) use in scheduling controlled substances. The DEA argued that the report’s recommendation to memorialize the government’s scheduling procedures does not constitute new evidence relating to whether cannabis should be rescheduled.
Specifically for the proposed Schedule III rule for cannabis, the FDA – under the direction 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.
In its responses filed this month, the DEA argued that the GAO report “makes no critical finding” regarding the actual scientific process and analysis, and that neither the Administrative Procedure Act (APA) nor the CSA provide for record supplementation and general discovery in rulemaking proceedings.
“Rather, under established law, the parties are entitled only to the disclosure of the documents and summary of the testimony upon which a party intends to rely,” the DEA wrote in its Oct. 20 response. “The only two exceptions to this blanket proposition are where a party makes a strong showing that: (1) the agency acted in ‘bad faith;’ or (2) the record is so limited that it will frustrate effective judicial review. None of the moving parties have made the requisite showing here.”
When the three anti-rescheduling parties (the “movants”) asked Julius to reopen the proceedings earlier this month, they submitted five requests for documents and testimony, including:
- 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.
The DEA argued that the anti-rescheduling parties had the opportunity to cross-examine its expert witness, Dominic Chiapperino, Ph.D., a scientist who serves as the director of controlled substance staff for the FDA’s Center for Drug Evaluation and Research (CDER). The DEA argued in its Oct. 20 response that Chiapperino’s testimony fulfills requests one through four listed above.
“The movants had full opportunity to cross-examine Dr. Chiapperino about the particulars … and explore any avenues they believed to be fruitful,” the DEA argued this week. “The movants’ request to reopen this line of inquiry – after they had the opportunity to do so – would give them a ‘second bite at the apple’ to which they are not entitled.”
In a shorter response Julius afforded to the movants, they argued on Oct. 21 that there was no “first bite” at the apple because the DEA declared the two-part test off limits – citing Department of Justice’s (DOJ) Office of Legal Counsel’s (OLC) 2024 opinion that the two-part test was sufficient – and because a Touhy letter from the FDA limited the scope of Chiapperino’s testimony during the summer hearing.
Regarding the movants’ fifth request, the DEA argued:
“Given the GAO report’s clear findings, explanation about how it performed its review, and various appendixes and citations, the government is uncertain what movants believe is missing from the report that require[s] discovery to complete the administrative record.”
These requests are why Julius ordered the DEA to submit a second response.
The DEA also argued that the APA “disfavors” supplementing the record and discovery in administrative matters in this matter, especially given the DEA did not “deliberately or negligently” exclude documents in the hearing process and did not engage in “bad faith or improper behavior” in compiling the record.
Furthermore, the DEA argued that the movants are not entitled to supplement the record with the GAO report because they did not “identify a basis allowable under the APA,” and they cannot rely on broad categories of materials that are “likely” to exist. The agency also argued the movants aren’t entitled to discovery because their requests are not “limited” and “narrowly tailored” but rather seek broad categories of materials and testimony (requests one through four).
“Because the GAO report does not create a material issue of fact sufficient to rebut the presumption against record supplementation or discovery in this administrative matter, and because movants cannot show bad faith or a sparse record, their request to reopen this hearing to supplement the administrative record and engage in discovery must fail,” the DEA argued.
It’s now up to Julius to grant or deny the various motions from the movants.
