Last week, in response to a Freedom of Information Act request by Houston lawyer Matthew Zorn, the Department of Health and Human Services (HHS) revealed the rationale for its August 2023 recommendation that the Drug Enforcement Administration (DEA) move marijuana from Schedule I to Schedule III of the Controlled Substances Act. The document not only contradicts the position that the DEA has long taken on this issue; it contradicts the position that HHS itself took in 2016, when the DEA rejected a 2011 rescheduling petition. The reversal shows that marijuana's classification has always been a political question rather than a legal or scientific matter.
On October 7, 2022, the same day he announced a mass pardon for people convicted of simple marijuana possession under federal law, President Joe Biden instructed HHS and Attorney General Merrick Garland to "initiate the administrative process to review expeditiously how marijuana is scheduled under federal law." Biden noted that Schedule I, which includes "heroin and LSD," is "the classification meant for the most dangerous substances" and is "even higher than the classification of fentanyl and methamphetamine—the drugs that are driving our overdose epidemic." On Twitter, he reiterated that "we classify marijuana at the same level as heroin" and treat it as "more serious than fentanyl," which he said "makes no sense."
In short, it was clear that Biden did not expect HHS to confirm its previous position that marijuana belongs in Schedule I. He expected HHS to recommend that marijuana be moved to a lower schedule, which is what it ultimately did. As the details of the HHS recommendation clarify, that decision was not based on new scientific evidence. It was based on a reinterpretation of the criteria for Schedule I that could have been implemented much sooner if HHS and the DEA had been open to it, or if a previous president had encouraged it.
Under the Controlled Substances Act (CSA), Schedule I supposedly is reserved for drugs with "a high potential for abuse" that have "no currently accepted medical use in treatment in the United States" and no "accepted safety for use…under medical supervision." The CSA authorizes the attorney general, in consultation with HHS, to decide whether a substance meets those criteria, and the attorney general historically has delegated that authority to the DEA. The DEA has long maintained that a substance can have a "currently accepted medical use" only if there is enough evidence to satisfy the Food and Drug Administration's requirements for approving a prescription drug.
In its response to a 2020 rescheduling petition, for example, the DEA conceded "the possibility that drugs containing marijuana or its derivatives might, in the future, be proven to be safe and effective for the treatment of certain conditions and thus approved…by the United States Food and Drug Administration [FDA] for marketing." But "until then," it said, "we will continue to identify opportunities to assist researchers in this area while never losing sight of the need to protect the public," which, as HHS and the DEA saw it, meant keeping marijuana in Schedule I.
Strictly speaking, the scenario described by the DEA had already come to pass. Back in 1985, the FDA approved Marinol, gelatin capsules that contain a synthetic version of THC (a.k.a. dronabinol) in sesame oil, as a treatment for the nausea and vomiting caused by cancer chemotherapy. It 1992, the FDA approved Marinol as a treatment for AIDS wasting syndrome. Marinol was originally placed in Schedule II, but in 1999 the DEA moved it to Schedule III, which also includes prescription drugs such as codeine, buprenorphine, and anabolic steroids. In 2016, the FDA approved Syndros, an oral THC solution, for the same indications as Marinol. Syndros remains in Schedule II. And in 2018, the FDA approved Epidiolex, an oral solution of marijuana-derived cannabidiol (CBD), as a treatment for two forms of severe, drug-resistant epilepsy. Epidiolex is a Schedule V drug.
Once those medications were approved by the FDA, the DEA had no choice but to place them in a schedule lower than marijuana. But despite the evidence that "drugs containing marijuana or its derivatives" were safe and effective medicines, marijuana itself remained in Schedule I, as required by the DEA's reading of the CSA. The recommendation that HHS produced in response to Biden's instructions rejects that interpretation of the statute, saying a drug can have a "currently accepted medical use" even if there is not enough evidence for it to pass muster with the FDA.
In place of the DEA's definition, HHS uses a two-part test. Part 1 asks "whether there is widespread current experience with medical use of marijuana in the United States by licensed HCPs [health care practitioners] operating in accordance with implemented state-authorized programs, where such medical use is recognized by entities that regulate the practice of medicine under these state jurisdictions." Since 38 states have approved medical use of marijuana, it easily satisfies this prong.
"More than 30,000 HCPs are authorized to recommend the use of marijuana for more than six million registered patients," HHS notes. That means there is "widespread clinical experience associated with various medical conditions recognized by a substantial number of jurisdictions across the United States."
HHS thus embraces one of the main arguments that Zorn and his colleague Shane Pennington made on behalf of marijuana researcher Suzanne Sisley in a 2020 brief asking the U.S. Court of Appeals for the 9th Circuit to reject the DEA's interpretation of the criteria for Schedule I. Zorn and Pennington argued that "widespread acceptance" of medical marijuana by the states, "the traditional gatekeepers of the medical profession" under our federalist system of government, "forecloses placement in Schedule I."
In 2021, a 9th Circuit panel rejected that appeal, ruling that the plaintiffs had "failed to exhaust their administrative remedies." But in a concurring opinion, Judge Paul Watford observed that the DEA "may well be obliged to initiate a reclassification proceeding for marijuana, given the strength of petitioners' arguments that the agency has misinterpreted the controlling statute by concluding that marijuana 'has no currently accepted medical use in treatment in the United States.'"
Part 2 of the new HHS test for that criterion asks "whether there exists some
credible scientific support for at least one of the medical conditions for which the Part 1 test is satisfied." After reviewing the relevant literature, HHS concludes that there is "credible scientific support" for marijuana's use as a treatment for pain, for nausea and vomiting, and for "anorexia related to a medical condition." That conclusion, it emphasizes, is "not meant to imply that safety and effectiveness have been established
for marijuana that would support FDA approval of a marijuana drug product for a particular indication."
What about the other Schedule I criteria? Regarding "potential for abuse," the HHS analysis underlines the slipperiness of the concept, which the CSA does not define. The fact that people like marijuana, for example, counts as one piece of evidence that suggests its potential for abuse. As HHS puts it, "there is ample epidemiological evidence that marijuana is self-administered by humans because of its ability to produce rewarding psychological effects, such as euphoria." But while HHS notes widespread nonmedical use of marijuana, it draws a distinction between use and abuse even in that context—a distinction that has always been anathema to the DEA.
"Evidence shows that some individuals are taking marijuana in amounts sufficient to create a hazard to their health and to the safety of other individuals and the community," HHS says. "However, evidence also exists showing that the vast majority of individuals who use marijuana are doing so in a manner that does not lead to dangerous outcomes to themselves or others."
Marijuana use "may lead to moderate or low physical dependence, depending on
frequency and degree of marijuana exposure," HHS says. "It can produce psychic dependence in some individuals, but the likelihood of serious outcomes is low, suggesting that high psychological dependence does not occur in most individuals who use marijuana." While "experimental data and clinical reports demonstrate that chronic, but not acute, use of marijuana can produce both psychic and physical dependence in humans," it says, "the symptoms associated with both kinds of dependence are relatively mild for most individuals."
HHS also notes that "the risks to the public health posed by marijuana are low compared to other drugs of abuse," such as heroin (Schedule I), cocaine (Schedule II), and benzodiazepines such as Valium and Xanax (Schedule IV). That conclusion is "based on an evaluation of various epidemiological databases for [emergency room] visits, hospitalizations, unintentional exposures, and most importantly, for overdose deaths." Although "abuse of marijuana produces clear evidence of harmful consequences, including substance use disorder," HHS says, they are "less common and less harmful" than the negative consequences associated with other drugs.
In "various epidemiological databases" compiled from 2015 to 2021, HHS notes, "the utilization-adjusted rate of adverse outcomes involving marijuana was consistently lower than the respective utilization-adjusted rates of adverse outcomes involving heroin, cocaine, and, for certain outcomes, other comparators. Also, the rank order of the comparators in terms of adverse outcome counts typically placed alcohol or heroin in the first or immediately subsequent positions, with marijuana in a lower place."
Given the conclusion that marijuana has a "currently accepted medical use," it plainly does not belong in Schedule I. And given the evidence regarding its relative hazards, HHS now thinks, placement in Schedule III makes sense. "While marijuana is associated with a high prevalence of abuse," it says, "the profile of and propensity for serious outcomes related to that abuse lead to a conclusion that marijuana is most appropriately controlled in Schedule III under the CSA."
The practical implications of that change, assuming the DEA agrees to it, are relatively modest. The biggest immediate impact would be felt by state-licensed marijuana suppliers, which under Section 280E of the Internal Revenue Code cannot deduct standard business expenses on their federal tax returns. That disability, which applies to illegal suppliers of Schedule I or Schedule II drugs, results in punitively high effective tax rates that make it difficult to turn a profit, let alone invest in expansion. Moving marijuana to Schedule III also would facilitate medical research by eliminating regulatory requirements that are specific to Schedule I.
Rescheduling marijuana would not make it legally available as a prescription drug, except in the form of products approved by the FDA. Nor would it address the conflict between state laws that allow medical or recreational use and a federal law that treats state-licensed marijuana businesses as criminal enterprises. Those businesses would still have trouble obtaining financial services, and they would still be subject to criminal penalties and civil forfeiture, outcomes that recreational marijuana suppliers avoid only thanks to prosecutorial discretion.
The HHS recommendation is nevertheless significant as an implicit acknowledgment that drug warriors for decades have bent reality and the law to fit a predetermined conclusion that marijuana belongs in Schedule I. The points that HHS is finally conceding about marijuana's risks and medical potential were clear long before last August. Way back in 1988, the DEA's chief administrative law judge, Francis Young, concluded that marijuana did not meet the criteria for Schedule I, only to be overruled by DEA Administrator John Lawn.
Meanwhile, the whole controversy about how to classify marijuana has been overtaken by events beyond the control of federal bureaucrats. Three-quarters of the states have legalized the medical use of marijuana, and most Americans now live in states that also have legalized recreational use. And while federal regulators quibble about which schedule is appropriate for marijuana, an overwhelming majority of Americans think it should not be scheduled at all.
The post The Newly Unveiled HHS Rationale for Rescheduling Marijuana Underlines Drug Warriors' Dishonesty appeared first on Reason.com.
