Why Reschedule Marijuana?

Ever since Congress passed the Controlled Substances Act (CSA) in 1970, drug policy reformers have complained that marijuana does not belong on Schedule I, the statute’s most restrictive drug category. Schedule I ostensibly is reserved for drugs with a “high potential for abuse” that have “no currently accepted medical use” and are so dangerous that they cannot be used safely, even under medical supervision. It is highly debatable, to say the least, that marijuana meets any of those criteria, let alone all three. But over the years, most recently in 2011, the Drug Enforcement Administration (DEA) has repeatedly rejected petitions asking it to take marijuana off Schedule I, where it sits alongside heroin and LSD, above supposedly safer drugs such as cocaine, morphine, and methamphetamine.

In light of President Obama’s recent observation that marijuana is safer than alcohol, CNN’s Jake Tapper wondered if he was open to reconsidering marijuana’s status as a Schedule I drug. When Tapper asked him that in an interview that aired last week, Obama derailed the conversation by denying that the executive branch has the power to reclassify marijuana. That clearly is not true, since the CSA gives the attorney general the authority to move drugs between schedules. The attorney general has delegated that authority to the DEA (a division of the Justice Department), which is why that agency has been the recipient of petitions urging it to put marijuana in a less restrictive category.

Because Obama incorrectly insisted that rescheduling marijuana would require an act of Congress, he never addressed the merits of doing it administratively. From the perspective of people who believe marijuana should be legalized for medical or general use, the advantages of such a move are not as substantial as you might think. But neither are they, as UCLA drug policy expert Mark Kleiman claims, “identically zero.” Moving marijuana to a less restrictive legal category would have some significant practical effects, perhaps the most important of which would be to advance a more honest discussion of marijuana’s hazards and benefits.

As Kleiman points out, removing marijuana from Schedule I would not automatically make it legal for medical use, since any cannabis product still would have to be approved by the Food and Drug Administration (FDA). “For a doctor to prescribe it,” notes Aaron Houston, a Marijuana Majority board member and WeedMaps lobbyist, “there would have to be an FDA-approved formulation of it.”

Since marijuana itself cannot be patented, a pharmaceutical company would not have much incentive to go through the arduous, time-consuming, and expensive process required to gain FDA approval. Furthermore, drug regulators tend to look askance at herbal medicine, preferring isolated chemicals. “They’re never going to approve a whole-plant organic product,” says Dan Riffle, director of federal policies at the Marijuana Policy Project.

Rick Doblin, executive director of the Multidisciplinary Association for Psychedelic Studies, which for years has been trying to jump through the hoops required to get marijuana approved as a medicine, disagrees. “FDA, like most regulatory agencies, wants to expand the areas it regulates,” he says. “FDA does want to regulate botanical drugs and would be willing to approve whole-plant organic products if Phase 3 studies demonstrate safety and efficacy.”

In any case, rescheduling marijuana might make it easier to conduct research on the plant’s medical utility, which could lead to cannabis-derived medications that would pass muster with the FDA. “The biggest obstacle, at least historically, to doing research on marijuana to prove its medical benefit is that it’s in Schedule I,” Riffle says. “So you had that Catch-22, where marijuana is a Schedule I drug because there’s no evidence, and there’s no evidence because marijuana is a Schedule I drug.”

Harvard psychiatrist Lester Grinspoon, co-author of Marihuana: The Forbidden Medicine and a leading expert on cannabis, agrees that marijuana’s Schedule I status has impeded research. “Since 1970,” he says, “it has been the major reason why the kinds of large double-blind studies which have been the basis for FDA approval of medicines since the mid-1960s have been impossible to pursue in this country.” Dale Gieringer, who runs the California chapter of the National Organization for the Reform of Marijuana Laws, notes that “there are very burdensome registration requirements and regulations regarding Schedule I substances.” Although “most of them also apply to Schedule II,” he says, they do not apply to substances in Schedules III through V, which are deemed to have progressively lower potential for abuse.

There are other research obstacles, unique to marijuana. In 1999, responding to the legalization of medical marijuana in California, the Clinton administration imposed an additional layer of review on research involving cannabis, requiring approval by the Public Health Service as well as the FDA, the DEA, and the relevant institutional review board. And even after they get all the other necessary approvals, researchers have to obtain marijuana from the National Institute on Drug Abuse (NIDA), which has a monopoly on the legal supply—something that is not true of other Schedule I drugs. NIDA, an agency whose mission focuses on marijuana’s hazards, has not been keen to assist research aimed at measuring its benefits. Although neither of these requirements is a necessary consequence of marijuana’s Schedule I status, they would be harder to defend if marijuana were reclassified, which would mean acknowledging that it has medical value and can be used safely.

Rescheduling marijuana would not affect the legal status of state-licensed cannabusinesses in states such as Colorado and Washington, which would still be criminal enterprises in the eyes of the federal government. But Gieringer notes that rescheduling could remove one of the major financial challengesfacing state-legal marijuana suppliers: Section 280E of the Internal Revenue Code prohibits the deduction of business expenses related to “trafficking in controlled substances,” but only for drugs on Schedule I or II. If marijuana were moved to, say, Schedule III, that prohibition would no longer apply.

Schedule III, which is supposed to be for medically useful drugs that can be taken safely and have a lower abuse potential than drugs on Schedules I and II, arguably is appropriate for marijuana because that is where the DEA put Marinol (a.k.a. dronabinol), a synthetic version of THC, marijuana’s main active ingredient. The DEA also has said naturally occurring THC used in generic versions of Marinol belongs on Schedule III.

But depending on how you define abuse potential, marijuana could go on a lower schedule. “When you look at the Schedule IV drugs,” says SUNY at Albany psychologist Mitch Earleywine, author of Understanding Marijuana, “you’ve got the opiate Tramadol, the stimulant Modafinil, lethal sedatives like phenobarbital and chloral hydrate, and the ‘date rape’ drug rohypnol. Surely cannabis is safer than these.”

Grinspoon believes “none of the schedules is truly appropriate for marijuana.” But if it he had to pick, he says, “based on a realistic appraisal of the drug, I would put it in Schedule V.” That category, which includes codeine and opium preparations, is for prescription drugs with the lowest abuse potential.

Rick Doblin notes that the DEA could move cannabis to a lower schedule only if it changed its definition of “currently accepted medical use,” which demands the sort of large-scale, multi-site, double-blind studies that the FDA requires to approve a new drug. “Assuming that marijuana has been approved as a prescription medicine by the FDA,” Doblin says, “Schedule II seems too high, since Marinol is in Schedule III. Due to its actual abuse potential, marijuana for medical use should be in Schedule V.”

Alex Kreit, a professor at Thomas Jefferson School of Law in San Diego who studies drug policy, notes that the CSA leaves undefined phrases on which scheduling hinges. The DEA therefore “has enjoyed incredibly broad discretion to interpret and define ‘potential for abuse’ and other scheduling criteria,” Kreit writes on the Marijuana Law, Policy & Reform blog. Just as it could adopt a less demanding definition of “accepted medical use,” the DEA could take a narrower view of “abuse,” which it equates with any nonmedical use. By that standard, marijuana, by far the most popular illegal drug, does indeed have a high potential for abuse. But that judgment seems peculiar if abuse is defined as problematic use, in which case potential for abuse might be measured by the percentage of users who become addicted or suffer serious harm.

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