The Drug Enforcement Administration (DEA) unveiled who it plans to call as expert witnesses, and what they plan to testify on, for the upcoming cannabis rescheduling hearing that will begin June 29 in Arlington, Va.
The DEA filed its prehearing statement on June 24, proposing the following witnesses:
- Dominic Chiapperino, Ph.D., who serves as the director of controlled substance staff for the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research; and
- Corey Burchman, M.D., a licensed medical doctor in New Hampshire who practiced as a board-certified anesthesiologist and pain management physician until 2019.
The purpose of the DEA’s administrative law judge (ALJ) hearing is to receive “factual evidence and expert opinion” regarding whether cannabis should be reclassified from Schedule I to Schedule III under the Controlled Substances Act (CSA).
As the proponent (not necessarily a supporter) of the proposed rule, the DEA bears the burden of proof that cannabis has currently accepted medical use in the U.S. and that its potential for abuse is less than substances listed in Schedules I and II of the CSA.
The seven anti-rescheduling parties that the DEA invited to participate in the hearing will all have the opportunity to cross-examine the government’s witnesses. DEA Administrator Terry Cole sent rejection letters to all pro-rescheduling petitioners, stating that they did not meet the “interested person” definition of being “adversely affected or aggrieved” by the proposed rule.
Derek C. Julius, the DEA’s new chief ALJ presiding over the hearing, has the authority to approve proposed witnesses and limit the scope of their testimonies.
The FDA authorized Chiapperino to testify on the following three topics:
- The scientific and medical determinations underlying the FDA’s eight-factor analysis performed on cannabis’s accepted medical use and potential for abuse, as transmitted to the DEA in August 2023, with the U.S. Department of Health and Human Services’ (HHS) accompanying recommendation for a Schedule III listing;
- The scientific and medical determinations underlying the analysis performed and conclusions drawn by the FDA, specifically that cannabis has currently accepted medical use (CAMU) for: (i) anorexia related to a medical condition; (ii) nausea and vomiting (e.g., chemotherapy-induced); and (iii) pain; and
- FDA’s recommendation that cannabis be placed in Schedule III.
“Dr. Chiapperino will testify about his background and experience, including his experience performing scientific evaluations of drugs that require drug scheduling or rescheduling under the Controlled Substances Act,” the DEA said of its “fact” witness in the June 24 prehearing statement.
“Dr. Chiapperino will testify to FDA’s assessment of the findings necessary to support placement in Schedule III, namely that marijuana has a potential for abuse less than the drugs or other substances in Schedules I and II, that marijuana has a CAMU for at least one therapeutic condition, and that abuse of marijuana may lead to moderate or low physical dependence or high psychological dependence,” according to the prehearing statement.
Meanwhile, the DEA plans to have Burchman testify as an expert and fact witness. Burchman has been a practicing physician for more than 30 years and also serves as a managing partner for the Pavilion Group, which specializes in assessing and exploring business opportunities within the wellness and hospitality sectors, as well as the cannabis and hemp industries.
Burchman has also written extensively on evidence-based research findings regarding cannabis as a therapeutic intervention for glaucoma.
“Dr. Burchman will testify as a medical expert in the practice of pain management, with significant clinical experience in the use of medical marijuana,” according to the DEA’s prehearing statement. “Dr. Burchman will testify that he provided direct patient care for pain patients as an anesthesiologist and pain management physician following his residency and fellowship training in 1986 until 2019. He will testify that he was practicing at the Dartmouth-Hitchcock Medical Center in Hanover, N.H., when the medical center began prioritizing medical marijuana as a treatment modality for pain patients, and he worked to transition many patients from treatment with opioids to treatment with marijuana. Dr. Burchman will further testify that, in his medical opinion, medical marijuana provides a medical benefit to pain patients.”
Proving that cannabis has “currently accepted medical use” is a key burden for removing any substance from Schedule I. Any substance determined to have CAMU cannot be listed in Schedule I under the CSA.
However, it’s unclear if, and to what extent, Julius will allow witnesses to testify on medical cannabis during the hearing, because U.S. Acting Attorney General Todd Blanche issued an order in April that already reclassified state-licensed medical cannabis to Schedule III. Only nonmedical cannabis remains listed in Schedule I.
“Importantly, the scope of this hearing is not to discuss the rescheduling of … medical marijuana products already regulated by the states, which has already occurred,” the ALJ wrote in a preliminary order. “Accordingly, no evidence or testimony will be received on that matter. The narrow issue in this matter is whether the remainder of marijuana, as defined in the CSA, should be transferred from its current place on Schedule I of the list of controlled substances to Schedule III.”
Julius’ order comes despite the proposed rule for the hearing not distinguishing between medical and nonmedical cannabis, but rather all cannabis.
That said, the crux of the DEA’s proposed testimony from Burchman focuses on matters regarding medical cannabis that’s already placed in Schedule III. The DEA’s prehearing statement explicitly says that Burchman’s testimony will be based on the New Hampshire medical cannabis model, given his experience treating pain patients and working with medical cannabis dispensaries.
“Dr. Burchman will testify that he routinely reviews the medical literature on the use of medical marijuana for treatment of pain and uses that information to direct his patient treatment plans,” according to the DEA’s prehearing statement. “He will also testify that he consults with other physicians on the treatment plans of their patients and provides medical advice to cannabis, professional medical, and various government or quasi-government offices and organizations.
“Dr. Burchman will also testify about patient safety measures utilized in the industry regarding the cultivation, processing and dispensing of medicinal marijuana, including caps on the monthly amount of medicinal marijuana allowed per patient, along with product QR codes, certificates of analysis and testing by certified labs.”
