Politics
DEA And Marijuana Rescheduling Opponents File Final Briefs In Hearing Ahead Of Judge’s Decision
The Drug Enforcement Administration (DEA) is reiterating that it doesn’t believe a recently published federal watchdog agency report that found “gaps” in the government’s process for evaluating controlled substances undermines the Trump administration’s proposal to reschedule marijuana. But anti-rescheduling parties that are participating in a hearing on the reform say that procedural shortcomings have irreparably tainted the scientific review that the proposed reclassification is based on.
Both sides on Thursday filed what are expected to be the final briefs in the process on before the agency judge overseeing the hearing issues his recommendation on the proposal to the agency’s administrator.
Last month, DEA Chief Administrative Law Judge Derek Julius rejected cannabis rescheduling opponents’ request to reopen the proceedings for additional testimony and document discovery concerning the Government Accountability Office (GAO) report. However, he did allow the report itself to be entered into the record and invited participating parties to file “narrowly tailored” briefs on how much “weight” it should have in the hearing and to what extent it affects marijuana rescheduling.
Parties’ initial briefs were filed last week, and they had an opportunity to reply to one another’s submissions by Thursday.
DEA’s latest filing reiterates that it believes the judge should give “no weight” to the GAO report in preparing his cannabis rescheduling recommendation—saying that opponents’ arguments “are not supported by the record or law” cited in their own briefs.
The agency said that anti-rescheduling parties’ filings have largely repeated claims they already made during the hearing, underscoring what DEA says is the lack of new value brought to the proceedings by the GAO report.
“Instead of addressing the probative value of the Report, the Movants are using this process to reargue matters that were debated at the hearing and which this Report provides no new information,” DEA said. “[T]his Report is simply not probative on issues known to the parties prior to the Report’s publication.”
The watchdog agency report found, among other things that DEA “does not have any policies or procedures regarding how its staff are to conduct evaluations or schedule substances” and the Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) “does not have policies or procedures specifying how its staff are to conduct evaluations or develop scheduling recommendations for substances.”
DEA said in its new brief that if it is the case that the GAO report’s findings undermine the current recommendation to move marijuana to Schedule III then they should also raise questions about whether a prior 2016 review that left marijuana in Schedule I was “appropriately performed,” as anti-cannabis parties have claimed.
“Movants argue that the prior 2016 rescheduling process was appropriately performed, yet the presence or absence of internal written protocols would have impacted marijuana’s prior 2016 rescheduling review as well as the instant rescheduling. Movants cannot have it both ways. There is no indication that the agencies used a different set of internal written guidelines in 2016 than were used in 2023… Thus, the Government’s internal written guidelines for the rescheduling reviews appeared consistent between 2016 to 2023. Thus, Movants’ preference for the 2016 marijuana rescheduling recommendation over the current recommendation is based on an outcome more favorable to their position, not the presence (or absence) of internal written guidelines.”
Finally, DEA said anti-reform parties’ argument in recent briefs “fails to consider the voluminous scientific and medical information collected, presented, and examined at the hearing.”
Meanwhile, a joint brief filed on Thursday by the National Drug & Alcohol Screening Association (NDASA), DUID Victim Voices and Kenneth Finn—anti-rescheduling parties that initiated the question of inserting the GAO report into the hearing record—argues that the document “provides evidence that the Government’s process was flawed, and cannot carry the burden of proof necessary to warrant rescheduling marijuana to Schedule III.”
“Critical and decisive process gaps that affected critical and decisive decision-making—left entirely unexplained—render the Government unable to prove marijuana should be rescheduled,” the anti-reform parties’ brief says.
“It follows that before the Government can prove its conclusion, it must first show that the test it applied was justified and appropriate. Ordinarily, that showing is made by pointing to an established procedure adopted in advance so it cannot be shaped to reach a desired result. Procedures developed by a body with the relevant expertise, through a deliberative and open process. Procedures published so anyone can apply them and check the work. Procedures applied consistently across cases, so like matters are treated alike. Here, as noted in the GAO Report, no procedures were adopted in advance; many were devised inside a black box, amid political pressure, and in an ad hoc way specifically for this proceeding; and they departed in critical ways from past rescheduling analyses.”
The anti-rescheduling parties acknowledged that “nothing indicates that DEA and FDA used a different set of internal written guidelines in the prior marijuana rescheduling attempts.”
“Those prior rulemakings are not at issue, but the sudden change in recommendation still requires explanation,” the brief said. “A deficient process that produces opposite scheduling recommendations demonstrates the fatal flaw GAO identified: without written procedures, the route to this rescheduling proposal is not reproducible, reviewable, or sufficient to carry the Government’s burden of proof.”
As they have previously, the opponents argued that a new two-part test federal officials used to analyze cannabis’s accepted medical use improperly departs from a former five-part test.
“The Government has never produced any policy, procedure, or underlying basis for its arbitrary, capricious, unexplained, unreasoned, and outcome-determinative two-part test decree. If such procedures or bases existed, the Government could have resolved this issue simply by producing them. It did not, because, as GAO found, they do not exist. What remains is the determinative methodological choice on which the entire decision to reschedule marijuana rested—the selection of the two-part test—and no one knows who ultimately made the choice or why. If the one all-important decision determining this process is unknowable, unquestionable, and unreviewable, what has been the purpose of this exercise? The Government’s hand-waving on this point is telling.”
In 2024, the Department of Justice’s (DOJ) Office of Legal Counsel (OLC) said the prior five-part test was “impermissibly narrow” and said the two-part review “is sufficient to establish” that a drug has a currently accepted medical use.
Julius, the judge overseeing the proceedings, said last month that some of the information cannabis rescheduling opponents wanted new testimony and discovery about under their broader request to reopen the hearing is “immaterial for the narrow purpose of this hearing” and others “could have been explored” by hearing participants during earlier questioning of witnesses—but he did allow the new round of briefing about the GAO report.
DEA said in a previously filed brief that opponents’ request to reopen the hearing was an “obvious fishing expedition based on a Report that is clear on its face.”
The agency said in another brief that it was fine with including the GAO document in the hearing record, as opponents have pushed for, but it did not want any further briefings on the matter.
Attorney General Todd Blanche in April issued an order that immediately reclassified state-licensed medical cannabis, as well as marijuana products approved by the Food and Drug Administration (FDA) from Schedule I of the Controlled Substances Act (CSA) to Schedule III.
Under a separate order he signed, the DEA hearing was held in June and July to consider more comprehensively moving marijuana to Schedule III.
“The Government is not putting forth any evidence to suggest that marijuana is not dangerous. All controlled substances by definition are dangerous,” James Schwartz, a DEA attorney, said on the opening day of the hearing, according to the transcript. “That is why they are scheduled in the first place. However, controlled substances must be evaluated by the risks they pose balanced with the medical use they provide.”
“The proposed rule, the supporting documents, and the Government witnesses will establish that marijuana has a currently accepted medical use,” he said. “With that determination, marijuana can no longer remain in Schedule I.”
The federal agency, which was charged with defending the proposed rescheduling move, said in its brief that “marijuana no longer fits the statutory requirements for Schedule I because it has a currently accepted medical use within the United States and it has an accepted safety for its use under medical supervision.”
The agency noted that under the law it must give “significant deference” to an “extensive ten-month study on the scientific and medical properties” of cannabis conducted by the Department of Health and Human Services (HHS), which recommended rescheduling.
“Currently there are over 30,000 practitioners treating more than six million patients in 43 U.S. jurisdictions,” DEA said. “Such practices demonstrate that there is no longer a lack of accepted safety for use of marijuana under medical supervision, and as such, marijuana does not fulfill the requirements of being a Schedule I substance.”
It also said that there is “substantial evidence sufficient to show that marijuana’s abuse and dependency profiles better align with Schedule III substances than Schedule II” or Schedule I. “The vast majority of individuals who use marijuana do so in a manner that does not result in dangers to themselves or to their communities.”
In conclusion, DEA asked the judge overseeing the hearing to “expeditiously recommend” that marijuana be transferred from Schedule I to Schedule III.
During the hearing, DEA officials charged with defending the cannabis rescheduling proposal highlighted testimony on marijuana’s medical benefits and its relative safety compared to other substances such as alcohol and opioids. That included appearances from a Food and Drug Administration (FDA) scientist and a medical doctor from New Hampshire who detailed how medical marijuana provides relief to pain patients and can serve as an alternative to opioids.
Meanwhile, lawyers and witnesses for parties who are oppose marijuana rescheduling and participated in the hearing put significant focus on the alleged harms of cannabis use as well as criticism of recently adopted changes to an analysis used to determine whether drugs have accepted medical value.
DEA invited only organizations and people who oppose marijuana reform to join the hearing as designated participants—telling supporters that they do not meet the definition of an “interested person” to participate because they are not “adversely affected or aggrieved by any rule or proposed rule issuable.”
Ahead of the hearing’s start, marijuana reform activists held a press conference outside DEA headquarters to highlight how they feel the have been “shut out” of the process—criticizing the fact that no supporters of reform were invited to participate and that the proceedings were not livestreamed despite officials’ vows of “transparency.”
Marijuana Moment sent requests to Julius, the DEA judge, and to Cole, the DEA administrator, requesting they reverse a decision to prohibit the public from tuning into the cannabis hearing via livestream. A congressman and other journalists later joined in that request.
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A prior hearing process on the marijuana rescheduling process that was initiated by the Biden administration stalled last year amid litigation over alleged improper communications and witness selection.
The current marijuana rescheduling process is being challenged with several lawsuits that have been consolidated by a federal appeals court. Those pieces of litigation against the cannabis reform have been filed by state attorneys general, marijuana legalization opponents and a cannabis-focused biopharmaceutical corporation.
The U.S. Court of Appeals for the District of Columbia Circuit recently rejected a drug testing industry association and a pharmaceutical company’s request to block the Trump administration from moving forward with cannabis rescheduling while the litigation is considered. The parties have jointly filed a proposed briefing schedule for the legal dispute.
A congressional committee recently voted to block federal officials from taking further steps to carry out cannabis rescheduling, though bipartisan lawmakers told Marijuana Moment they don’t believe that provision will be enacted into law.
Read the latest briefs in marijuana rescheduling hearing below:
https://www.documentcloud.org/documents/28873443-dea-rescheduling-hearing-gao-reply-briefs/
