After HHS used its own two-part test to determine the plant’s ‘currently accepted medical use,’ rescheduling opponents urge DEA to keep its five-part test.
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When all is said and done, Attorney General Merrick Garland has to offer three findings before the U.S. Drug Enforcement Administration (DEA) issues its pending decision to potentially reclassify cannabis under the Controlled Substances Act (CSA).
Does cannabis have currently accepted medical use in the U.S.?
What’s cannabis’s relative abuse potential?
What’s cannabis’s physical and psychological dependence liability?
Setting international treaty obligations aside, Shane Pennington, partner at Porter Wright Morris & Arthur LLP, who specializes in cannabis law, said the first finding trumps all others in the current rescheduling process.
“The reason ‘currently accepted medical use’ matters so much is because it’s kind of intuitive that if you can say that cannabis has a currently accepted medical use, then we know it doesn’t belong in Schedule I,” he said. “So then the question is, OK, well now what schedule does it belong in?”
This question comes at a time when 38 states have legalized medical cannabis in the U.S., and when more than 8 million adults self-reported consuming cannabis under the authorization of their physician in 2020, according to data published in the American Journal of Preventive Medicine.
But to determine whether a drug or substance has currently accepted medical use, the DEA has traditionally utilized 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; and
The scientific evidence is widely available.
For cannabis, in particular, the first part of this five-part test as it relates to “reproducible” creates an impassable roadblock to rescheduling, Pennington said. He provided an example of hemp farmers cutting down plants that tested just below the federal 0.3% THC threshold to be legally defined as hemp and then taking a lunch break while their crop sat in the field.
“If you leave it out there while you go eat your bologna sandwich or whatever, and it’s sunny, the sun beats down on those plants that have been cut down and it decarboxylates some of the other compounds in the hemp, and it turns those into delta-9 THC,” he said. “So, when you come back, instead of loading hemp in your truck, you’re loading marijuana.
“And the reason I’m saying this and pointing it out is because it just proves there’s no way you’re going to have repeatable chemistry. … It’s a plant. … The only way you can get anything from cannabis that meets that [reproducible] standard is to extract it, isolate it as a compound, and turn it into a pharma drug.”
Notably, this has led to federal lawmakers from both ends of the rescheduling spectrum to demand that the DEA shed light on its review process following the Department of Health and Human Services’ (HHS) recommendation in August 2023 that cannabis be relisted to Schedule III under the CSA.
This is because rather than using the DEA’s five-part test to determine whether cannabis has currently accepted medical use in the U.S., the HHS used a two-part test in its review:
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?
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 tomerely "consider" under the CSA before making a recommendation in its entirety.
To satisfy the first part, HHS officials confirmed that more than 30,000 health care practitioners across 43 U.S. jurisdictions are authorized to recommend cannabis for more than 6 million registered patients with at least 15 medical conditions.
And for the second part, HHS included an evaluation based on systematic reviews of studies investigating the safety and effectiveness of cannabis, as well as relevant professional societies’ position statements, and data from state programs and national surveys.
“By linking it to science, they made it so that now it’s a matter of HHS expertise,” Pennington said, referring to a 252-page document HHS released in January to explain the reasoning behind its Schedule III recommendation. The department made the document public after multiple Freedom of Information Act requests and after Matthew Zorn, partner at Yetter Coleman, filed a lawsuit.
While HHS recommendations to the DEA are binding on scientific and medical matters under federal law, according to 21 U.S.C. § 811(b), whether DEA officials are still using their five-part test from 1992 or the two-part test HHS officials utilized in their 2023 recommendation makes a significant difference in cannabis’s ability to meet the currently accepted medical use standard for rescheduling.
And U.S. lawmakers recognize this.
Cannabis rescheduling opponent Sen. John Cornyn, R-Texas, pressed HHS Secretary Xavier Beccera on the issue during the U.S. Senate Judiciary Committee’s hearing March 14, specifically asking him about the details of the Food and Drug Administration’s (FDA) scientific analysis.
FDA is an agency within HHS that conducted the scientific analysis before HHS sent its recommendation to the DEA.
Despite his position at the helm of HHS, Beccera was reluctant to address the specifics of FDA’s analysis when Cronyn asked him why the scientific analysis used to determine cannabis’s currently accepted medical use only included two factors instead of five.
“Your office has created a new two-factor test to determine currently accepted medical use,”
Cornyn said during last week’s committee hearing. “What’s the reason for the change?”
Becerra pointed Cornyn to HHS’ 252-page explanation of its review, which states that HHS
“updated” its analysis—not created a new one (the significance of this is detailed below).
“There has been a lot of science that’s been collected over the years on cannabis,” Beccera said. “We have far more information now. As you know, throughout the country, many states have moved much farther than the federal government has. Even in places like Texas, you see where action has been taken on cannabis. What we’re doing is simply reflecting what the science is showing.”
Cornyn then asked Becerra about the second of three findings that must be made before cannabis is potentially rescheduled: its relative abuse potential.
“You compared it to heroin in terms of its potential for abuse,” the senator said. “Why didn’t you compare other types of drugs that are scheduled by your office?”
Becerra said he didn’t want to speak directly for the FDA, which he said conducted the analysis independently from HHS.
“They are the agency that has been tasked with that job with their scientists, and I won’t try to speak for them, but what I will tell you is that the rigorous work that was done to come to these conclusions was based on the science and the evidence they had before them,” the health secretary said.
After Cornyn went on and pressed Becerra on research into cannabis’s potential effects on adolescent brain development, mental health, and pregnant women, Becerra said FDA officials took into consideration “all the information out there.”
“I’m sure that the FDA would’ve taken into account all the different circumstances involved,” he said. “I didn’t make the recommendation. It was made by FDA.”
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For clarity, Assistant Secretary of Health Rachel Levine, M.D., who works just under Becerra, signed the official recommendation letter sent to DEA Administrator Anne Milgram in August.
Although Becerra didn’t specifically address Cornyn’s question about the reasoning behind HHS utilizing a two-part test to determine cannabis has currently accepted medical use in the U.S., Pennington said he believes the point Cornyn was trying to make is that the two-part test was made up out of thin air and therefore defective.
But Pennington said this is not the case.
“There’s a rule of law in administrative law that courts definitely apply,” he said. “If you’re going to create a new test for something like this, that’s fine. If you’re an agency, you can create a new standard—totally cool. But when you do, you have to say, we’re creating a new standard, and the reason we’re using this standard instead of the one that we used to use is X, Y, and Z. And explain it. As long as you do that, courts will be like, ‘good to go.’”
Rescheduling opponents like Cornyn and U.S. House Rep. Andy Harris, R-Md., continue to argue that HHS wrongly leaned on a new, unreliable two-point standard and therefore the August recommendation to DEA was “misguided.”
But there is nothing in the 252-page document to suggest the two-point test is a newly created standard, Pennington said.
Instead, the HHS wrote in the report that it “has updated its analysis of a substance’s currently accepted medical use in treatment in the U.S.” for purposes of the CSA.
Importantly, Pennington said HHS officials did not make up the two-part test but rather fleshed out an already existing standard from 1982, one that predates DEA’s five-part test by a decade.
According to an HHS notice on proposed recommendations to DEA regarding the scheduling status of “marihuana and its components” in the June 29, 1982, issue of the Federal Register, “a drug may also, theoretically, be legally marketed without violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) if it is manufactured, processed and used entirely within a single state without any connection at all with interstate commerce.”
In this instance, HHS officials were considering whether cannabis had obtained accepted medical use by virtue of “totally intrastate production” but found no basis at the time. (California didn’t become the first state to legalize medical cannabis until 14 years later.)
While cannabis did not satisfy the “intrastate production” standard when the HHS recognized this possibility in 1982, cannabis satisfies this standard today, Pennington said.
In addition, HHS cited the American Medical Association Council on Scientific Affairs in the 1982 Federal Register to back its view that cannabis did not have accepted medical use in therapy or treatment by physicians practicing medicine at the time in the U.S.
“Suffice to say that around 1982, HHS and DEA both recognized that currently accepted medical use basically meant—in the United States—meant that a substance had to be able to be legally used as medicine in the United States,” he said. “That was basically what they came to.”
And although the FD&C Act—a pharmaceutical pipeline for drugs to receive FDA approval through a process of clinical trials—provides one avenue for a drug to obtain accepted medical use status, it’s not the only avenue, HHS determined in 1982.
Thus, in 2023, when HHS/FDA officials conducted a scientific and medical analysis of cannabis and determined the plant does have currently accepted medical use in U.S., they did so by using an updated two-part test from four decades earlier, Pennington says.
“It’s literally being accepted and used in treatment in the United States all over the place,” he said. “So, if ever there was something that met the [intrastate production] standard that HHS talked about back in the day, it’s this.”
And if DEA officials follow HHS’s determination that cannabis has currently accepted medical use, “you’re a tap-in birdie putt away from Schedule III,” Pennington says.
But the DEA has yet to make its process public.
