The Drug Enforcement Administration (DEA) made it clear on June 29 that the government not only is the proponent of a Biden-era proposed rule to loosen restrictions on cannabis as a Schedule III substance, but it “supports” the rule, too.
James J. Schwartz, an attorney in the Diversion Section of the DEA’s Office of Chief Counsel, didn’t waste time addressing the elephant in the room during the government’s opening statement at the DEA headquarters in Arlington, Va., where the much-anticipated administrative law judge (ALJ) hearing commenced proceedings to consider the merits of the proposed rule.
With the DEA inviting only seven anti-rescheduling parties to participate in what is perhaps the most consequential drug reform decision in over 50 years, some pro-rescheduling advocates questioned whether the government was deliberately throwing the match. Others suggested it was all part of the plan under a directive from President Donald Trump to “complete the rulemaking process … in the most expeditious manner” possible.
“The government is here today as the proponent of the proposed rule signed by a previous attorney general recommending the movement of marijuana from a Schedule I to Schedule III controlled substance,” Schwartz said Monday. “In support of the proposed rule, the government is providing two witnesses to assist the tribunal: a scientist and a practitioner.”
The DEA called its first witness, Dominic Chiapperino, Ph.D., of the U.S. Food and Drug Administration (FDA), on the first day of the two-week hearing, which is scheduled to conclude no later than July 15. Three of the seven anti-rescheduling parties also had the chance to cross-examine Chiapperino on Monday. The other four are scheduled to do so on Tuesday.
Before Chiapperino’s testimony and before the cross-examinations, Schwartz made clear that the hearing is not about two things: It’s not about recreational cannabis use, and it’s not about legalization, he said.
Instead, the DEA attorney said the government’s two witnesses and supporting documents will lay the groundwork to overcome the burden of proof that cannabis has currently accepted medical use (CAMU) in the U.S.
Whether a drug has CAMU is one of three findings that government officials must make when considering the appropriate schedule for a substance. The other two findings include the substance’s relative abuse potential and its physical and psychological dependence liability.
But determining CAMU is key, because it means cannabis can no longer be listed as a Schedule I drug under the Controlled Substances Act (CSA).
Gary Kaminsky, a regulatory attorney who specializes in navigating compliance landscapes in complex industries like cannabis, was one of roughly 25 members of the public who attended the hearing on June 29 in Arlington, where the DEA’s courtroom has limited seating capacity.
“It was interesting to hear the lead DEA counsel, almost from the first words, say that the focus of this hearing is CAMU, and that their burden is to prove that there is one CAMU, and if there is one CAMU, marijuana would not be able to be on Schedule I,” he said. “I don’t know if that’s revelatory to us all, but it makes you realize that this is a very substantive hearing.”
The proposed rule leans on the U.S. Department of Health and Human Services’ (HHS) determination in August 2023 that cannabis has CAMU for the treatment of three conditions: anorexia related to a medical condition, nausea and vomiting (e.g., chemotherapy-induced), and pain.
Schwartz also said that Derek C. Julius, the DEA’s new ALJ overseeing the hearing, can’t entertain arguments about whether the HHS’s two-part test to determine CAMU is legally permissible.
“That decision has already been made,” he said, referring to the Department of Justice’s (DOJ) Office of Legal Counsel’s (OLC) 2024 opinion that the HHS’s two-part test was sufficient, even though the DEA has traditionally used a five-part test it created in response to a court challenge in 1992.
Anti-rescheduling parties have called into question the two-part test because it omits a key standard established in the five-part test to determine CAMU: Is the drug’s chemistry known and reproducible? Some argue that that standard creates an impassable roadblock to rescheduling botanical cannabis because a plant doesn’t have repeatable chemistry.
Schwartz said that anti-rescheduling parties can’t challenge the two-part test during the hearing because the OLC’s opinion is binding on the DOJ, “including the DEA and this tribunal.”
But that didn’t stop David Evans, one of the attorneys representing the National Drug & Alcohol Screening Association (NDASA), from trying.
“Why is HHS and DEA abandoning the five-part test?” he asked Chiapperino during cross-examination.
Evans withdrew the question after the DEA’s legal team objected.
Evans’ one hour of allotted time for cross-examination turned into two hours due to the DEA’s repeated objections, mostly because the DEA’s legal team felt his questions were speculative or fell outside the scope of the hearing or Chiapperino’s Touhy letter from the FDA.
More on Evans’ cross-examination, as well as those from other interested parties, will be detailed in a follow-up article.
Day One Testimony
On the first day of the two-week ALJ hearing, DEA Attorney Lisa Man went on to call the government’s first witness to testify: Dominic Chiapperino, Ph.D.
Editor’s note: Cannabis Business Times was the lone media outlet represented during Chiapperino’s testimony. The New York Times health reporter Jan Hoffman, who covers drug addiction and health law, was present during Monday afternoon’s portion of the hearing, when three of the seven anti-rescheduling participants had the opportunity to cross-examine Chiapperino.
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. But Chiapperino has worked for the FDA since 2002, including responsibilities as a chemistry reviewer for manufacturing and controls data related to drug quality.
“I did this for investigational drugs under investigational new drug applications and also for drugs submitted under a marketing application – a new drug application,” Chiapperino said, explaining that in his previous role, he was responsible for assuring the quality, potency and purity of drugs before human consumption.
As the CDER director since 2018, Chiapperino said he’s overseen 40 or so drug review evaluations that have covered roughly 120 substances, including cannabis.
Chiapperino helped lead the FDA 10-month scientific and medical evaluation of cannabis conducted alongside the HHS, which led to the department’s Schedule III recommendation to the DEA in August 2023.
The FDA and HHS’s review for cannabis included physicians, pharmacologists, epidemiologists and other experts who made their conclusions that the plant’s potential for abuse and its dependence liability are less than substances listed in Schedules I and II of the CSA based on an eight-factor analysis.
Man’s line of questioning for Chiapperino was geared toward building a record for potential judicial review, again focusing on the two-part test for CAMU:
- 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?
“Has that two-part test been used since it was implemented by HHS?” she asked about the department’s methodology.
“Yes,” Chiapperino said. He called the latter part of the two-part test a “totality” of the data. “We looked at clinical studies. We looked at data from surveys about medical use patterns. We considered the FDA approval of two drugs.”
The CDER director mentioned Marinol and Syndros, medicines that contain dronabinol, a synthesized THC that is approved for chemotherapy-induced nausea and vomiting.
Chiapperino explained that the FDA and HHS pulled from five sources of information to determine that cannabis has CAMU for at least three medical conditions:
- A set of national surveys;
- Literature review by the University of Florida’s epidemiology team;
- Literature review by the FDA’s medical officer team;
- State surveys from Minnesota and Maryland; and
- The FDA-approved use of Marinol and Syndros.
Chiapperino said both his team and the University of Florida found credible scientific support for CAMU, with the most available studies at their disposal – 39 clinical trials – focused on cannabis as a treatment for pain.
“The studies were more supportive of therapeutic benefit for patients with neuropathic pain,” he said. “I think there was at least one study with moderate quality of evidence showing benefit.”
Man’s line of questions dove further into the FDA and HHS’s scientific and medical analysis, including the review of national surveys to consider things like the proportion of Americans using cannabis medically, their age and purchasing patterns, and patterns of people asking health care practitioners for advice before seeking medical cannabis.
Chiapperino pointed out that in states without legalized medical cannabis programs, 47% of people still sought advice from health care practitioners before using medical cannabis.
“Presumably they were getting it from an illicit source in that state,” he said.
In states that have adult-use and medical cannabis programs, roughly 60% of people sought advice from health care practitioners before using medical cannabis, he said.
“The fact that many people are still seeking health care practitioner advice in states where they have access to marijuana, with or without that advice, shows that medical use is genuine and people are very interested in using marijuana as medicine,” Chiapperino said.
Man also questioned the government’s witness about safety issues related to the state surveys from Minnesota and Maryland. Chiapperino said his team determined there were “very low” instances of concerns and that “there were not many significant adverse events.”
In Minnesota, he said about 50% of medical cannabis patients returned for a second purchase, he said.
Man also directed Chiapperino’s attention to his team’s findings on cannabis’s relative abuse potential, physical dependence and safety concerns when compared to other controlled substances, including heroin (Schedule I); fentanyl, oxycodone, hydrocodone and cocaine (Schedule II); ketamine (Schedule III); and benzodiazepines, zolpidem and tramadol (Schedule IV).
The FDA also compared cannabis’s relative abuse potential to alcohol, which is not a controlled substance but one that Americans largely have access to for recreational purposes, Chiapperino said.
Man asked the FDA witness about the risk-ratio comparisons, including deadly seizures caused by heavy alcohol use.
“Are you telling the court today that marijuana has fewer overdose deaths than the comparators?” she asked.
“Yes, that’s what we observed,” he said.
Chiapperino also said that his team found that cannabis has similar withdrawal symptoms as tobacco, which is not a controlled substance.
Based on all of his team’s findings, Chiapperino confirmed that he believes the data supports cannabis’s placement in Schedule III, which he said aligns most with the plant’s properties.
According to the DEA’s line of questioning, cannabis, at the very least, no longer belongs in Schedule I.
“Did you and your team find credible scientific support to demonstrate a currently accepted medical use of marijuana to treat certain conditions?” Man asked.
“Yes,” Chiapperino.
