Politics
DEA Says Trump’s Marijuana Rescheduling Move Isn’t Weakened By Federal Watchdog Report That Found ‘Gaps’ In Process
The Drug Enforcement Administration (DEA) says the Trump administration’s proposal to reschedule marijuana is not weakened by a recently published federal watchdog agency report that found “gaps” in the government’s process for evaluating controlled substances. Opposing parties that are participating in a hearing on the reform, however, are arguing that the findings undermine the effort to reclassify cannabis.
Last week, the judge overseeing the hearing 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.
DEA said in a brief submitted on Thursday that agency Chief Administrative Law Judge Derek Julius should give “no weight” to the GAO report in preparing his recommendation on rescheduling cannabis.
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 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.”
But DEA said in its brief that reform opponents “have not demonstrated that the substance of the GAO Report has any probative value” with respect to marijuana’s potential for abuse, currently accepted medical use (CAMU) or dependence risk—key factors in determining its scheduling status.
With respect to abuse potential, “the factors used by the Government were published and publicly available to the parties for more than two years prior to the hearing,” DEA said. “While the Movants may not agree with the abuse analysis performed, the factors the Government used to perform that analysis are not in dispute.”
While opponents have argued that a new two-part test federal officials used to analyze cannabis’s CAMU improperly departs from a former five-part test, DEA said the GAO report offers “no substantive commentary (critical or otherwise)” about the change in methods.
Similarly, the GAO analysis has “no substantive finding relative to HHS’s dependence risk assessment,” DEA said.
“For the foregoing reasons, the Government respectfully requests that the Court give the GAO Report no weight,” the brief concluded.
A joint brief filed 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—argued that the document “deserves decisive weight” in the marijuana scheduling proceedings “because it explains why the Government cannot answer two dispositive questions.”
“First, on what scientific or procedural basis did HHS apply the two-part test rather than the five-part test? Second, on what basis did it exclude evidence of psychiatric harm, prenatal exposure, cardiac events, suicide, and other societal harms? Because both the choice of test and choice of data decided the Government’s recommendation, and because no written procedure or internal control governed either one, the Government cannot meet its burden of proof. The tribunal should recommend rejection of the proposed rule on the present record.”
“The GAO Report shows that the Government lacks a documented, reviewable basis to reschedule marijuana and therefore cannot meet its burden,” the brief said. “The tribunal should recommend rejection of the proposed rescheduling of marijuana to Schedule III on the present record.”
The anti-rescheduling groups argued that the cannabis rescheduling process was “not an ordinary scientific review”—noting that it began with direction from the president and “moved forward amid industry stakes measured in billions of dollars.” The brief noted the efforts of the multi-state cannabis company Trulieve to court President Donald Trump on the issue—including via contributions to his inaugural committee and an executive’s attendance at fundraising events.
“An agency process that runs on unwritten ‘professional judgment’ took up marijuana under direct presidential instruction, amid intense financial stakes, lobbying, and campaign spending, on a compressed schedule,” the brief said. “Written procedures exist to guard against that danger. Without them, the tribunal cannot verify that evidence, rather than outside influence, drove the proposal. The Government bears the burden, and it cannot make that showing.”
The groups noted that federal agencies said they agree with the GAO report’s findings and have pledged to construct written policies going forward.
“The Government should obtain a new HHS evaluation under the written policy FDA has committed to develop,” the brief said. “That record must explain the relative-abuse comparison, the medical-use framework, product variability, dosing, public-health risks, and diversion. This record does not, and cannot therefore support rescheduling.”
In the meantime, they want the DEA judge to give the GAO report “decisive evidentiary weight” in the ongoing cannabis proceedings and “recommend rejection of the proposed rescheduling of marijuana to Schedule III on the present record.”
Prohibitionist organization Smart Approaches to Marijuana and the states of Idaho, Indiana and Nebraska also argued in a separate joint brief that fixing “deficiencies” identified by GAO would “improve consistency” in the drug scheduling process.
The report revealed that federal agencies “have no standardized means to evaluate marijuana’s relative potential for abuse,” their brief said.
“In other words, nothing stops the Government from arbitrarily altering the abuse profile of a drug by, for example, manipulating the comparators it selects in a given evaluation. The absence of standard policies for evaluating ‘relative’ abuse potential affords FDA the improper and unbridled discretion to isolate the most lethal substances as comparators (and ignore other Schedule II substances) to arrive at a pre-ordained conclusion that a substance without high overdose risk belongs in a less restrictive control schedule.”
SAM and the states also highlighted what they see as problems with the new two-part test on marijuana’s medical value.
The shift in analysis methods, the brief said, was “easily accomplished because HHS had—and still has—no written policies and procedures standardizing how it conducts” a drug scheduling review, which “explains how FDA was able to ‘depart from its usual mode of analysis’ so readily.”
“It is arbitrary and capricious for an agency to publish inconsistent evaluations of the same drug merely by shifting inputs and prioritizing different information,” the brief claimed. “The Tribunal should recommend that marijuana remain in Schedule I.”
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.
The Tennessee Bureau of Investigation (TBI) also submitted a brief arguing that “failures” in the drug scheduling process that were identified by GAO “cannot be ignored, particularly given that the resulting proposal reverses course on decades of HHS and DEA analysis on the correct schedule for marijuana.”
The GAO report is “competent, relevant, and material evidence regarding the policies and procedures, or lack thereof, that DEA and HHS utilize in connection with their duties in drug rescheduling,” TBI said. “The GAO Report conclusively demonstrates that the Attorney General’s [notice of proposed rulemaking] to reschedule marijuana departed from the required procedure in significant ways.”
Replies to the newly filed briefs are not required, but any parties wishing to submit them must do so by next Thursday, November 5.
Julius, the judge overseeing the proceedings, said last week 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 filed earlier this month that it is 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/28859694-dea-marijuana-rescheduling-gao-briefs/
Photo courtesy of Max Pixel.
