Those who participated in the Drug Enforcement Administration’s (DEA) 11-day cannabis rescheduling hearing that concluded July 15 are still reviewing the transcripts, which have yet to become publicly available.
The DEA, as the proponent of the proposed rule to reclassify cannabis as a Schedule III substance, and the seven anti-rescheduling parties whom the DEA invited to participate were provided daily transcripts within 48 hours of each day’s proceedings. They now have until Aug. 17 to propose corrections before the official hearing transcript sees the light of day.
Derek Julius, the DEA’s chief administrative law judge who oversaw the hearing, issued an order on July 16, instructing the designated parties that any proposed corrections to the transcript should be limited to misspelled names or words, a line of text attributed to the wrong speaker, or any other errors.
“This is not an opportunity for the parties to correct instances of misspeaking or to materially alter the testimony of witnesses that was given,” the judge wrote. “Punctuation and grammar are not essential corrections.”
Once the tribunal also reviews the transcript for possible errors, Julius will compare the lists of proposed corrections from the designated parties and adopt a fully reconciled copy of the transcript, which will then be posted on the DEA’s website for all to see.
While Julius allowed limited media and public attendance, he forbade the hearing from being televised, livestreamed or broadcast in any way. He also prohibited attendees from using recording devices.
“If anyone is observed on a cell phone or using any other recording-capable device … or if their cell phone is heard during the hearing, they will be removed by DEA security,” the judge said on the first day of the hearing. Cannabis Business Times was the lone media represented in the courtroom during his remarks that morning.
This means the details of the hearing remain exclusive to those who participated or attended, and the public – until after Aug. 17 – must take the word of those who were there.
The courtroom’s capacity at the DEA’s headquarters in Arlington, Va., was limited to roughly 50 people. Various attendees, including those who support or oppose loosening restrictions on cannabis, offered contrasting takes on who made the best case – the DEA or the anti-rescheduling parties – throughout the multiweek process.
But until an unbiased transcript is released, the public is left holding its horses.
What to Expect
The hearing showcased a one-versus-seven playing field, with the DEA offering testimony from two witnesses whom the seven anti-rescheduling parties could cross-examine and vice versa.
Whether the public believes the DEA or the anti-rescheduling parties made the best case to either reclassify cannabis as a Schedule III substance or keep it listed as a Schedule I substance does not necessarily matter; what matters is if the administrative record supports Julius’ eventual recommendation and DEA Administrator Terry Cole’s subsequent decision as to the appropriate schedule for cannabis.
The final transcript will serve as an evidentiary record for those hoping to challenge the eventual outcome of the administrative process. Cole’s expected rescheduling decision will likely be subject to judicial review.
The designated participants’ post-hearing briefs are also due by Aug. 17. The nonmandatory briefs are an opportunity for the DEA and the seven anti-rescheduling parties to file their proposed findings of fact, conclusions of law and closing arguments for the record.
The anti-rescheduling parties particularly made two key arguments during the hearing that they’ll likely reinforce in their briefs:
- Cannabis does not have currently accepted medical use in the U.S., and therefore must remain in Schedule I of the Controlled Substances Act (CSA); and
- The U.S. Department of Health and Human Services’ (HHS) 10-month scientific and medical evaluation that concluded in August 2023, which led to a Schedule III proposed rule, was flawed and is now outdated.
Whether a substance has currently accepted medical use (CAMU) is one of three findings that government officials must make when considering its appropriate schedule. The other two findings include the substance’s relative abuse potential and its physical and psychological dependence liability.
Anti-rescheduling parties took issue with the HHS performing a two-part test to determine whether cannabis has CAMU, arguing that it veered from the DEA’s traditional five-part test established in 1992. The five-part test weighs whether a substance’s chemistry is known and reproducible. Many pro- and anti-rescheduling parties agree that this creates an impassable roadblock to rescheduling botanical cannabis because a plant doesn’t have repeatable chemistry.
James J. Schwartz, an attorney in the Diversion Section of the DEA’s Office of Chief Counsel, argued on the first day of the hearing that the two-part test is legally permissible, citing the Department of Justice’s (DOJ) Office of Legal Counsel’s (OLC) 2024 opinion.
Dominic Chiapperino, Ph.D., the DEA’s first witness, testified that there were three avenues by which the U.S. Food and Drug Administration (FDA), which operates under the HHS, could have reached its finding that cannabis has CAMU, including the FDA’s approval of a new drug application, the five-part test and the two-part test.
Chiapperino is a scientist who serves as the director of controlled substance staff for the FDA’s Center for Drug Evaluation and Research (CDER), a position he’s held since 2018, overseeing 40-plus drug evaluations covering more than 120 substances, including cannabis.
Chiapperino made a key admission during the hearing.
“The third avenue is the two-part test that was established in 2023,” he said.
Anti-rescheduling parties could challenge this new test as valid – despite the 2024 OLC opinion – because under administrative law, when an agency creates a new standard or test, it must announce it, describe it and explain why the agency is deviating from a standard already in place.
Beyond the two-part test, Schwartz established during the hearing that the HHS utilized a team of “highly trained professionals” to conduct the 10-month review, including physicians, pharmacologists and epidemiologists. The department also consulted with a chemist and botanist.
The department formed four working groups, including one specifically focused on the CAMU review for cannabis. The FDA weighed seven health conditions commonly included as qualifying conditions for state medical cannabis programs and determined that cannabis has legitimate CAMU for the treatment of at least three: anorexia related to a medical condition, nausea and vomiting (e.g., chemotherapy-induced), and pain.
DEA Attorney Lisa Man asked Chiapperino what that meant for cannabis’s classification.
“We believed [cannabis] should be placed in Schedule III,” he said.
Corey Burchman, M.D., a licensed medical doctor in New Hampshire who practiced as a board-certified anesthesiologist and pain management physician until 2019, was the DEA’s second witness. He testified on medical cannabis’s efficacy in treating pain as an alternative to opioids in states that allow doctors to recommend it to their patients.
In examining whether cannabis has CAMU, the government determined in 2023 that more than 30,000 health care professionals are authorized to recommend cannabis to more than 6 million registered patients across the U.S.
The government’s 10-month analysis also compared cannabis’s potential for abuse and its physical and psychological dependence liability to other substances in all five schedules of the CSA, as well as two substances that aren’t classified: alcohol and tobacco.
Man again asked Chiapperino what his team recommended after making those comparisons.
“We believe the data supported placement in Schedule III as the schedule most aligned with marijuana’s properties,” he said.
This was the analysis the DOJ based its proposed Schedule III rule on, which the department published in the Federal Register in May 2024.
The seven anti-rescheduling parties, in building their record for a potential appeal, argued that the DOJ received bad intel, and that Chiapperino’s team of experts at the FDA performed a “shoddy job” in its evaluation, from excluding certain demographics to failing to consider drug diversion and violent crime, and relying on “outdated” survey data, among what they called other overlooked shortcomings.
They also argued that botanical cannabis cannot be prescribed, dosed and dispensed like traditional FDA-approved medications because of the plant’s variability.
The seven parties offered their own witnesses, from drug screening experts who stand to lose business should cannabis be rescheduled to a DEA pharmacologist who opposes rescheduling, psychiatry experts, a pharmacist, an emergency medicine physician, an impaired driving expert, a pain physician, the mother of a son who died by suicide, and drug and law enforcement officials.
Those witness testimonies focused on disputing the three HHS findings: that cannabis has CAMU, and its abuse potential and dependence liability are less than Schedule I and II comparators. The FDA conducted an eight-factor analysis before making those findings.
Whether the seven anti-rescheduling parties proved that cannabis should remain in Schedule I may not matter. Perhaps of greater importance is whether they proved the government failed to provide adequate evidence supporting a Schedule III listing.
After the corrected transcript is published, Julius will issue his recommendation as to the appropriate schedule for cannabis. Under the Code of Federal Regulations, the designated parties will then have 20 days to file exceptions to the recommended decision, findings of fact and conclusions of law.
The judge will then deliver his nonbinding recommendation and the administrative record to the DEA administrator, whose rescheduling action (or inaction) will become subject to judicial review should losing parties file an appeal.
