DEA Rejects Marijuana Rescheduling but Eliminates a Research Barrier
The agency won't reclassify cannabis but will make it easier for scientists to get the kind they need.
Today the Drug Enforcement Administration (DEA) is expected to reject two petitions asking it to reclassify marijuana while agreeing to loosen restrictions on the supply of marijuana for medical research. Although the drug's legal status will remain the same, the DEA's willingness to allow competition among marijuana suppliers should facilitate research by removing a bureaucratic bottleneck and improving the quality and variety of cannabis available to scientists investigating the plant's medical benefits.
The Washington Post reports that the DEA, despite much speculation to the contrary, is sticking to its longstanding position that marijuana belongs in Schedule I of the Controlled Substances Act (CSA), a category supposedly reserved for drugs with "a high potential for abuse" and "no currently accepted medical use," drugs so dangerous that they cannot be used safely even under a doctor's supervision. It is doubtful that marijuana meets any of those criteria, let alone all three. But the DEA, which has wide discretion to interpret and apply the CSA criteria, has always insisted that marijuana must stay in Schedule I until its medical utility is proven by the sort of large, expensive, randomized clinical trials the Food and Drug Administration (FDA) demands before approving a new pharmaceutical.
While such studies have been conducted with marijuana's main active ingredient (which is how Marinol, a capsule containing synthetic THC, was approved by the FDA in 1985) and are under way with Sativex, an oral cannabis extract spray, they have not been conducted with the whole plant. Consultation with the FDA is part of the scheduling process, and the Post reports that the agency unsurprisingly "concluded that medical and scientific data do not yet prove that marijuana is safe and effective as a medicine." The Post says that conclusion "prohibits the DEA from reclassifying the drug," which is not quite true, because the DEA is not obligated to define "currently accepted medical use" as narrowly as it does. But unless the DEA decided to repudiate that court-approved interpretation, it was inevitable that it would respond to the two latest rescheduling petitions the same way it responded to three earlier ones.
The DEA's decision to start licensing additional suppliers of marijuana is more surprising. Currently the only authorized source is the National Institute on Drug Abuse (NIDA), which obtains marijuana from a contractor at the University of Mississippi. That monopoly is anomalous, since the DEA allows multiple licensees to produce other Schedule I drugs for research. Scientists have complained that NIDA, whose mission emphasizes marijuana's hazards, has been reluctant to share its stash with researchers interested in marijuana's benefits. They also have been frustrated by the mediocre quality and minimal variety of NIDA's marijuana. Although the agency recently started offering strains that are high in cannabidiol, a compound in marijuana that shows promise in treating seizures, it still does not offer the high-THC strains that some researchers are interested in studying.
Despite these problems, the DEA has until now insisted on maintaining NIDA's marijuana monopoly, which is one of the ways it has obstructed the research it says is necessary to move marijuana out of Schedule I. A 2001 attempt to get DEA approval for a private source of marijuana, backed by the Multidisciplinary Association for Psychedelic Studies (MAPS), dragged on for a decade and ultimately failed, despite a positive ruling from an administrative law judge. The DEA rejected the MAPS petition in January 2009, just before Barack Obama took office. Instead of reversing that decision, Obama appointed the acting administrator who made it, Michele Leonhart, to head the agency. Now Leonhart, who famously refused to say whether marijuana is less dangerous than heroin, is gone, replaced by an acting administrator who calls medical marijuana "a joke" but apparently is willing to let researchers prove him wrong.
"As long as folks abide by the rules, and we're going to regulate that, we want to expand the availability, the variety, the type of marijuana available to legitimate researchers," Acting Administrator Chuck Rosenberg told NPR. "If our understanding of the science changes, that could very well drive a new decision."
Rosenberg emphasized that the decision to keep marijuana in Schedule I was based exclusively on a judgment about its medical value. "This decision isn't based on danger," he said. "This decision is based on whether marijuana, as determined by the FDA, is a safe and effective medicine, and it's not." But it was the DEA that decided to equate "currently accepted medical use"—a phrase the CSA does not define—with FDA approval. The DEA has the discretion to read that phrase more generously.
Even if marijuana were rescheduled, doctors would be allowed to prescribe cannabis-based medicine only if the product was approved by the FDA. But moving marijuana to a lower schedule would have made research easier by reducing the bureaucratic hassle and institutional stigma associated with it. A move to Schedule III or lower would have made it possible for state-licensed marijuana suppliers to deduct their business expenses, thereby solving one of the newly legal industry's major financial problems. Even a move to Schedule II would eliminate criminal penalties for marijuana ads and make publications that carry them officially "mailable." At least as significant as the immediate practical effect, the federal government's implicit recognition of marijuana's medical value could have had an important impact on the public policy debate at the national and state levels.
"It's really sad that DEA has chosen to continue decades of ignoring the voices of patients who benefit from medical marijuana," said Tom Angell, chairman of Marijuana Majority, in a press release. "President Obama always said he would let science—and not ideology—dictate policy, but in this case his administration is upholding a failed drug war approach instead of looking at real, existing evidence that marijuana has medical value."
Aaron Smith, executive director of the National Cannabis Industry Association, was a bit more upbeat. "We appreciate the positive step—however small—of opening up a few additional avenues for medical marijuana research," he said. "But patients deserve more, and Congress should help them by removing marijuana from the Controlled Substance Act, allowing state programs and medical research to move forward without interference."
Unlike moving marijuana from one category to another, removing it from the CSA's schedules altogether would effectively repeal the federal ban. But it is pretty clear that step would require an act of Congress, since the CSA says administrative scheduling decisions must comport with international drug control treaties, which allow medical use of cannabis but call for strict regulation.
Update: The DEA's press release announcing its decisions is here. You can read its responses to the rescheduling petitions here and here. Its new policy on marijuana for research is explained here.
