When Drug Enforcement Administration (DEA) pharmacologist Luli Akinfiresoye testified under a subpoena during the cannabis rescheduling hearing that concluded July 15, a pair of lawyers called it the “most consequential development” in the proceedings.
Akinfiresoye, who evaluates drugs and chemicals for abuse liability within the DEA’s Drug and Chemical Evaluation Section, served as an expert witness for prohibitionist group Smart Approaches to Marijuana (SAM), one of seven anti-rescheduling parties that participated in the 11-day hearing to debate the merits of the federal government’s proposed rule to reclassify cannabis as a Schedule III drug under the Controlled Substances Act (CSA).
In December 2024, Akinfiresoye submitted what she called a “scientific document” titled “Marijuana: Scientific Knowledge,” which she said she and her colleagues at the Drug and Chemical Evaluation Section prepared because the May 2024 notice of proposed rulemaking (NPRM) that former Attorney General Merrick Garland signed “had gaps in data.” The NPRM is to loosen restrictions on cannabis from Schedule I to Schedule III.
The Food and Drug Administration (FDA), under the direction of the U.S Department of Health and Human Services (HHS), conducted a 10-month scientific and medical analysis that concluded in August 2023, when the HHS formally recommended to the DEA that cannabis be placed in Schedule III.
As part of the 10-month review, the FDA conducted an eight-factor analysis to determine the plant’s proper control status under the CSA.
The Department of Justice (DOJ), through the DEA, typically conducts its own eight-factor analysis before making a final rescheduling decision, but, according to Akinfiresoye, the DEA did not do so before the DOJ published the NPRM in the Federal Register in May 2024.
“Ideally, when we publish an NPRM, we also publish an eight-factor analysis,” she said during her testimony. “In this case, that did not happen because one was not done.”
While the published NPRM stated that the “DOJ has reviewed the scientific and medical evaluation and scheduling recommendation provided by HHS and has conducted a separate review of the eight factors identified,” the DOJ conceded in many of the factors that the “DEA believes that additional data … may be appropriate for consideration” beyond the FDA’s analysis.
That’s where Akinfiresoye indicated that her 2024 scientific document, which she and her colleagues drafted to “mimic” the eight factors required for control, comes into play. In other words, her team’s scientific document wasn’t an official eight-factor analysis.
As part of the scientific document, the DEA’s Drug and Chemical Evaluation Section utilized a traditional five-part test to determine that cannabis does not have currently accepted medical use, colliding with the FDA’s new two-part test it established in 2023 to determine that cannabis in fact does have currently accepted medical use. By statute, drugs that have currently accepted medical use cannot be listed in Schedule I.
SAM attorney John McNichols, a partner at Torridon Law, asked Akinfiresoye if the five-part test is better.
“‘Better’ is not the right word,” she said. “It’s a more comprehensive test.”
McNichols asked her if the FDA’s two-part test makes “sense to you as a pharmacologist?”
“Scientifically, no,” Akinfiresoye said. “It lacked chemistry. It lacked consideration for safety. It lacked consideration for efficacy. … For [a] drug approved for medicine, it’s an important requirement.”
When Akinfiresoye appeared as an expert witness on July 7, Vicente LLP Counsel Neil Willner and Partner Shawn Hauser wrote that her testimony “placed substantial intra-agency disagreement into the record,” and also that it provided the opposed parties with their “strongest” record of review in a potential appeal, should the DEA ultimately move forward with a final rule to reschedule cannabis.
While the Vicente team had ears in the cannabis rescheduling courtroom, the transcript of Akinfiresoye’s testimony did not become publicly available until DEA Chief Administrative Law Judge Derek C. Julius released it on Aug. 25.
Although the DEA served as the proponent of the proposed rule to reschedule cannabis, one of its own scientists testified contrary to its evidence supporting the rule.
The DEA’s legal team did not cross-examine Akinfiresoye on July 7, and, when the DEA filed its post-hearing brief on Aug. 17, Akinfiresoye was the lone opposed party witness whom the agency did not attempt to discredit.
But will Akinfiresoye’s testimony be enough to influence Julius in his forthcoming cannabis scheduling recommendation to DEA Administrator Terry Cole?
Akinfiresoye explained during her testimony that the Drug and Chemical Evaluation Section did not prepare the scientific document in 2024 for the NPRM but rather to “provide the information sought by the NPRM” to fill gaps in the HHS/FDA’s data.
For example, the third factor in the eight-factor analysis covers “the state of current scientific knowledge regarding” a drug or substance – in this case, cannabis. In its conclusion, the HHS found that “the pharmacokinetic profile of marijuana varies greatly depending on route of administration.” For instance, inhalation and oral administration offer different onsets related to the psychological effects of delta-9 THC.
Likewise, the DEA noted in the NPRM that:
“There is considerable variability in the cannabinoid concentrations and chemical constituency among marijuana samples and that the interpretation of clinical data related to marijuana is complicated. A primary issue is the lack of consistent concentrations of Δ9-THC and other substances in marijuana, which complicates the interpretation of the effects of different marijuana constituents. Additionally, the non-cannabinoid components in marijuana may potentially modify the overall pharmacological and toxicological properties of various marijuana strains and products. DEA anticipates that additional data on other marijuana constituents, routes of administration of marijuana, and the impact on Δ9-THC potency may be appropriate for consideration.”
In that regard, Akinfiresoye testified that the eight-factor analysis was not complete when the NPRM was published in May 2024.
“We needed more data. Data was lacking. We needed more information,” she said. “So, the scientific document provided the general knowledge of the science of marijuana.”
Under the third factor of the eight-factor analysis, Akinfiresoye testified that she and the Drug and Chemical Evaluation Section covered whether cannabis has currently accepted medical use through utilizing a traditional five-part test that the DEA established in 1992.
Cannabis prohibitionists and legalization advocates alike have agreed that the five-part test creates an impassable roadblock to rescheduling botanical cannabis because a plant does not have “reproducible” chemistry.
The Drug and Chemical Evaluation Section’s decision to use the five-part test came despite the DOJ’s Office of Legal Counsel’s (OLC) 2024 memorandum opinion that the HHS/FDA’s newly established two-part test from 2023 was sufficient to determine currently accepted medical use.
The DEA’s legal team defended the two-part test during the first day of the rescheduling hearing on June 29, arguing that the OLC opinion makes it legally permissible. The two-part test asks:
- Are doctors and health care professionals recommending cannabis to patients in treatment under state regulation?; and
- Is there credible scientific evidence supporting the therapeutic effect for at least one medical condition?
The DEA also defended the two-part test in its post-hearing brief submitted on Aug. 17.
“HHS formulated a two-part inquiry to conduct this assessment because neither FDA approval nor DEA’s five-part test examine[d] whether health care practitioners are actually using a drug to treat a condition or whether the entities regulating those practitioners allow the drug to be so used,” the DEA’s legal team wrote. “FDA determined that ignoring widespread clinical experience with a drug that is sanctioned by state medical regulators when evaluating whether a drug has CAMU is at odds with the plain meaning of Section 812(b).”
During the hearing, Akinfiresoye testified that the Drug and Chemical Evaluation Section utilized the five-part test for its scientific document despite knowing that the OLC opinion allowed for the two-part test and that the two-part test “can be accepted.” She conceded that “it was my understanding that, you know, DEA could use it if they wanted to.”
Still, McNichols focused his line of questioning on what Akinfiresoye called a “more comprehensive” five-part test for currently accepted medical use:
- 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; and
- The scientific evidence is widely available.
Regarding the first part of that test, Akinfiresoye and her team at the Drug and Chemical Evaluation Section wrote in the scientific document that:
“The chemical constituents in marijuana, including delta-9-THC and other cannabinoids, vary significantly across different marijuana strains. Marijuana has many strains with high variability in the concentrations of delta-9-THC, the main psychoactive component, as well as other cannabinoids and compounds. In addition, the concentrations of delta-9-THC and other cannabinoids may vary between strains. Due to the variation of the chemical composition in marijuana strains, it is not possible to derive a standardized dose. Marijuana is not a single chemical and does not have a consistent and reproducible chemical profile with predictable or consistent clinical effects.”
McNichols read that section of Akinfiresoye’s scientific document during the hearing, but he left out the following part: “However, if a specific cannabis strain is cultivated and processed under controlled conditions, the plant chemistry may be consistent enough to derive standardized doses.”
The SAM attorney was focused on making the case that for cannabis to pass the “reproducible” standard of the five-part test, one would have to extract and isolate one of its compounds and turn it into a pharmaceutical drug.
Akinfiresoye testified that cannabis is “not a substance” because “a substance is a single molecular entity” under the CSA, confirming her belief that using cannabis to treat medical conditions without FDA approval can have serious safety risks.
She also testified that she disagreed with the HHS/FDA’s determination that cannabis has currently accepted medical use, and “there wasn’t clear data to support the use of marijuana for the treatment of chronic pain,” one of three medical conditions that the FDA determined cannabis had currently accepted medical use for the treatment of.
Akinfiresoye confirmed that the Drug and Chemical Evaluation Section’s findings on currently accepted medical use “appeared to be in tension or conflicting” with the HHS/FDA’s findings.
However, when McNichols asked whether she rejected the HHS’s conclusions, Akinfiresoye said she didn’t reach any such conclusion.
“We didn’t – we didn’t have to make that comparison,” she said. “We just conducted our own five-factor analysis that we’ve always applied to every drug that we have to evaluate within the CSA.”
Akinfiresoye went on to testify on state-licensed medical cannabis programs, increased access, and abuse, cannabis-use disorder and psychosis.
But central to her testimony was that cannabis does not pass the five-part test for currently accepted medical use while conceding that the two-part test is legally permissible and that the Drug and Chemical Evaluation Section did not reject the HHS’s conclusions based on that two-part test.
Julius, for his part as the judge who oversaw the proceedings, is now tasked with making a nonbinding recommendation to the DEA administrator, whose final decision on whether to keep cannabis listed in Schedule I or move it elsewhere will likely have to stand the test of judicial review based on the administrative record.
Akinfiresoye’s testimony is now cemented in that record.
