Politics
DEA Is OK With Including New Report In Marijuana Rescheduling Hearing As Opponents Seek More Testimony And Document Discovery
The Drug Enforcement Administration (DEA) says it has no problem with reopening the record for a hearing on the Trump administration’s marijuana rescheduling proposal to include a federal watchdog report that found there are “gaps” in the government’s process for evaluating controlled substances—though it doesn’t want further briefings on the matter.
Opponents of the reform, meanwhile, are pushing to further delay a decision in the proceedings by asking the judge to order a new round of testimony and discovery.
Opponents of cannabis rescheduling had asked that the recent Government Accountability Office (GAO) report on drug scheduling be included in the record, and DEA Chief Administrative Law Judge Derek Julius last month paused the proceedings and ordered DEA to weigh in on whether the document should be made a part of the process.
DEA’s newly filed brief argues that it defers to the judge on whether the GAO report should be included in the record, but it opposes opponents’ request for additional briefings to be ordered concerning what the report’s findings mean for cannabis rescheduling.
Those opponents have “mischaracterized the GAO Report and its impact” on the marijuana rescheduling process, the agency said, adding that it “does not present any new evidence salient to the issue before this Tribunal.”
That 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.”
DEA said, however, that the GAO report merely identified “gaps in the memorialization of rescheduling process, not any flaws in the rescheduling process itself.”
“Rather, the Report issued a recommendation that DEA and FDA ‘fill gaps’ in their written policies surrounding the process of rescheduling. This recommendation is immaterial to the actual scientific processes and analysis these agencies used. More importantly, the GAO makes no critical finding as to the actual scientific processes and analyses used by FDA and DEA in scheduling controlled substances and makes no recommendations as to other scientific processes and analyses that FDA and DEA should use in determining what schedule to place a substance. Moreover, the GAO Report does not ever opine on FDA’s ultimate conclusion that marijuana should be transferred to Schedule III. While the Government defers to this Tribunal as to whether the GAO Report should be late admitted into evidence, the Government asserts that any briefing on the GAO Report – a document that has no bearing on the ultimate issue of whether marijuana should be transferred to Schedule III – is unnecessary.”
“When a document’s meaning is clear, the court need not allow additional argument to interpret the document,” DEA said, urging the judge not to further delay his rescheduling recommendation by allowing additional briefings from parties.
Until now, the only expected remaining step in the proceedings had been for Julius to issue his own recommendation on marijuana rescheduling to the DEA administrator, who would then make a final determination on the policy.
But last month the judge granted the motion for a stay filed by the National Drug and Alcohol Association (NDASA), DUID Victim Voices and Kenneth Finn, M.D.—parties opposed to cannabis rescheduling that participated in the hearing and who now want the GAO report included as part of the record.
Other parties in the hearing were “permitted, but not required” to file briefs on whether the GAO report should be included in the marijuana rescheduling hearing record.
Prohibitionist organization Smart Approaches to Marijuana (SAM) and the states of Idaho, Indiana and Nebraska filed a joint brief arguing that the GAO report is “competent, relevant, and material evidence to proposed findings of fact and conclusions of law that directly bear on the Rescheduling determination before the Tribunal.”
“The Tribunal should also request supplemental briefing from the parties to address whether HHS’s lack of internal written policies contributed to an evaluation of marijuana that departed from prior agency practice,” the brief said.
The National Drug & Alcohol Screening Association (NDASA), DUID Victim Voices, and Kenneth Finn also filed a separate joint brief on Tuesday, arguing that “additional briefing is necessary because this dispute goes beyond whether the Report is admissible—it concerns what the Report means and why it matters.”
“The Government contends that the findings concern documentation rather than the analysis itself and that they do not affect the proposed rescheduling. The Government then accuses Interested Parties of ‘mischaracterizing’ the Report. Neither of the Government’s characterizations is true. The Report plainly found that DEA lacks written policies or procedures assigning roles, responsibilities, and procedures for collecting and analyzing data, conducting eight-factor analyses, determining schedule placement, considering HHS recommendations, and making final scheduling decisions. It also found that FDA lacks procedures for eight-factor analyses and scheduling recommendations and lacks criteria for determining ‘potential for abuse,’ including ‘abuse potential relative to other substances.’ Those findings go well beyond documentation and concern the governing process, including the standards and responsibilities that produce the agency’s legally required findings.”
The opponents’ brief also calls attention to their arguments that a new two-part test federal officials used to analyze cannabis improperly departs from a former five-part test.
“The Report’s findings bear directly on whether the agencies used a consistent, reviewable method here. It gives no reason for the change from the five-factor CAMU test to the two-part version,” it says. “That unexplained change matters because the hearing record shows that FDA began its work before the two-part test existed, was directed to use it, and never completed a five-factor analysis.”
“The Government cannot rely on an unexplained change in method to establish its desired Schedule III findings,” the opponents argue. “It also cannot admit it lacks established procedures for making findings on rescheduling that are required by law and then insist those deficiencies are immaterial.”
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.
NDASA, DUID and Finn also filed a separate motion on Tuesday asking the DEA judge to order a “narrow reopening of the hearing for limited discovery and testimony tied to the Report, the agency-process gaps it identified, and why those gaps matter to marijuana rescheduling.:
They are requesting authority to “serve narrowly tailored document requests and to seek testimony limited to” certain specific subjects:
(1) Who selected, recommended, directed, drafted, or approved the July 2023 two-part CAMU test for marijuana; when that occurred; and what records or other information explain why HHS used that test after FDA’s evaluation had begun.
(2) Who prepared or materially revised the Part 1 and Part 2 CAMU language in the HHS recommendation; and what role DEA, FDA, HHS, NIH, OLC, and outside participants played in such preparation or material revision.
(3) Why the 2023 HHS evaluation did not address mental-health effects, psychosis, schizophrenia, the gateway effect, high-potency products, cardiovascular disease, pregnancy and prenatal exposure, diversion, pediatric use, geriatric use, or other public-health evidence in the same manner as earlier marijuana evaluations and the hearing record.
(4) What written or unwritten criteria FDA used for “potential for abuse,” “relative potential for abuse,” and the Schedule III comparison required by 21 U.S.C. § 812(b)(3)(A).
(5) What policies, procedures, memoranda, training materials, role assignments, agency communications, written responses, and technical comments GAO reviewed or requested regarding eight-factor analyses, schedule placement, consideration of HHS recommendations, and final scheduling decisions.
“The requested discovery is necessary and proportionate. It targets the process facts GAO identified, the factual disputes the Government created in its response, and the issues the Government restricted during the hearing,” the motion says. “It does not seek a broad reopening, a new merits case, or duplicative testimony already taken. Limited discovery is therefore proportional to the issues the Report and the Government’s response have placed before the tribunal.”
It remains to be seen whether Julius will order additional briefings on the GAO report and whether he will take the more far-reaching step of reopening testimony and discovery.
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 briefs in marijuana rescheduling hearing below:
