The Drug Enforcement Administration (DEA) indicated on Nov. 26 that during an upcoming cannabis rescheduling hearing, it may call into question a method used by a fellow agency to determine that the plant has “currently accepted medical use.”
The U.S. Department of Health and Human Services (HHS) used a two-part test to make this determination before formally recommending to DEA Administrator Anne Milgram in August 2023 that cannabis be reclassified from a Schedule I to Schedule III drug under the Controlled Substances Act (CSA).
This two-part test includes:
Are doctors and health care professionals recommending cannabis to patients in treatment under state regulation?; andIs there credible scientific evidence supporting the therapeutic effect for at least one medical condition?
The HHS’ determination that, yes, cannabis does pass this two-part test is significant in that any substance that has currently accepted medical use in the U.S. cannot be listed as a Schedule I drug and therefore would need to be relisted under the CSA.
This test was just one component of a scientific and medical evaluation the HHS conducted in cooperation with the Food and Drug Administration at President Joe Biden’s directive.
However, the DEA signaled on Tuesday that it may challenge the two-part test as a legitimate method, calling it a “novel” test since it veered from a five-factor test traditionally used by the DEA to determine the appropriate schedule for a drug.
“DEA made a request to the Department of Health and Human Services (HHS) and its operating division, the Food and Drug Administration (FDA), to provide witnesses to testify before the Tribunal regarding the scientific and medical evaluations in the HHS Eight Factor analysis that is the basis for the Notice of Proposed Rulemaking, including the novel two-factor test applied by HHS for determination of ‘currently accepted medical use,’” DEA attorneys wrote in a prehearing statement submitted to DEA Administrative Law Judge John J. Mulrooney on Nov. 26. Mulrooney is tasked with presiding over a fair and transparent rescheduling hearing.
Editor’s note: This two-part test is specifically to determine cannabis’s “currently accepted medical use” in the U.S.—just one component of the rescheduling review and completely different from the eight-factor analysis HHS officials were statutorily bound to merely “consider” under the CSA before making a recommendation in its entirety.
The HHS rejected the DEA’s request to provide witnesses from its department or the FDA, according to the DEA’s prehearing statement.
Specifically, the DEA will serve as the “proponent” for a proposed rule to reschedule cannabis during the ALJ hearing that will commence with preliminary proceedings on Dec. 2 and resume with witness testimonies in early 2025. The purpose of the hearing is to debate the merits of the proposed rule for a Schedule III listing.
While the DEA is the authoritative agency for the hearing, its administrative head, Milgram, did not sign off on nor endorse the proposed rule—the Department of Justice did through Attorney General Merrick Garland’s signature. Still, the DEA has special privileges to call and cross-examine witnesses during the hearing.
“In the event DEA determines it is necessary to subpoena a witness or witnesses from HHS (or its operating divisions), DEA respectfully requests to reserve the ability to add that witness in a supplemental filing,” DEA attorneys wrote in Tuesday’s statement.
After the HHS released its 252-page evaluation to the public in January 2024 (shedding light on its two-part test), rescheduling opponents urged the DEA to dismiss that method and instead utilize a five-part test it created in response to a court challenge in 1992, which provides that a drug has accepted medical use in treatment in the U.S. only if:
The drug’s chemistry is known and reproducible;There are adequate safety studies;There are adequate and well-controlled studies proving efficacy;The drug is accepted by qualified experts; andThe scientific evidence is widely available.
When it comes to a plant, however, the first part of this five-part test becomes a fool’s errand.
“The only way you can get anything from cannabis that meets that [reproducible chemistry] standard is to extract it, isolate it as a compound, and turn it into a pharma drug,” Shane Pennington, partner at Porter Wright Morris & Arthur LLP, told Cannabis Business Times in March.
While rescheduling opponents argued the HHS determination was misguided because it can’t just make up a new standard out of thin air without providing sufficient reasoning and explanation, Pennington attests that it wasn’t a new standard to begin with but rather a fleshed-out standard from 1982 that predated the DEA’s five-factor test.
RELATED: DEA’s 5-Factor Test Makes Rescheduling Cannabis Impossible
Although the DEA hasn’t secured witnesses from the HHS or FDA for the ALJ hearing, it proposed two witnesses from its own agency:
Heather Achbach, the acting section chief of the Regulatory Drafting and Policy Support Section (DPW) of DEA’s Diversion Control Division; andLuli Akinfiresoye, Ph.D., a pharmacologist in the Drug and Chemical Evaluation Section (DOE) of DEA’s Diversion Control Division.
The DEA plans to have Achbach testify on the DOJ-backed rulemaking process that led up to Garland’s signed proposal and the 60-public period that ensued with 43,564 comments on the DOJ’s notice of proposed rulemaking (NPRM) that was published in the Federal Register.
“She will testify that DEA provides its response to comments in the final published rule, which can include grouping the comments into categories and responding to those categories,” according to the DEA’s prehearing statement. “She will further testify that the responses to comments in the final rule express DEA’s official view as, in the usual course, the final rule is signed by the administrator or the administrator’s designee.”
Meanwhile, Akinfiresoye will testify on the HHS’s evaluation as well as the DEA’s independent evaluations regarding controlled substances and data that the agency uses to do so.
“Dr. Akinfiresoye will also testify that she is aware that the NPRM specifically seeks additional data upon which DEA can rely in making its determination as to whether marijuana should be rescheduled,” according to the prehearing statement. “Dr. Akinfiresoye will testify that DEA has maintained an active review of the scientific, medical and technical literature addressing marijuana with a focus on how it relates to the eight factors relevant to the control under the CSA.”
More specifically, Akinfiresoye will testify and provide data, studies and other information on the following topics:
Marijuana’s actual or relative potential for abuseScientific evidence of marijuana’s pharmacological effectsThe state of current scientific knowledge regarding marijuanaMarijuana’s history and current pattern of abuseThe scope, duration and significance of abuseWhat, if any, risk there is to the public healthMarijuana’s psychic or physiological dependence liability
While these topics may help the DEA determine its view of the appropriate schedule for cannabis, currently accepted medical use is the driving factor for removing the plant from its Scheule I status.
The Drug Enforcement Administration indicated it could target a ‘novel’ two-factor test used to determine currently accepted medical use. Read More
