DEA’s latest promise to facilitate medical cannabis research should be viewed with skepticism
For the second time in three years, the U.S. Drug Enforcement Agency has promised to move forward with plans to facilitate FDA-approved marijuana-related research in the United States. But if past is precedent, don’t expect changes any time soon.
That’s because the agency has dragged its feet on this issue for decades. Under federal regulations dating back to the late 1960s, only a single licensed entity — the University of Mississippi — is permitted to cultivate and provide cannabis for clinical research purposes. (By contrast, the federal government licenses multiple producers for other schedule I controlled substances, like MDMA.)
This monopoly has stifled clinical investigations into the marijuana plant. Notably, the cannabis grown by the University is often of inferior quality and fails to accurately reflect the types of varieties commercially available in the United States.
Further, the University only provides scientists with the option to access herbal cigarette formulations of the plant, not concentrates, edibles, or extracts —varieties that are commonly available in legal states.
Strains high in the compound cannabidiol (CBD) — a chemical of particular interest to many scientists — are also not currently available from the University.
The DEA is well aware of these issues. In fact, the agency’s own administrative law judge ruled in 2007 that there existed “an inadequate supply of marijuana available for research purposes,” and therefore determined that permitting the privately licensed production of cannabis for research purposes would be “in the public interest.”
The agency, however, rejected the judge’s order — opining that doing so would potentially be in violation of international anti-drug treaty obligations.
The agency then appeared to reverse this position in 2016, when it announced the adoption of new regulations explicitly “designed to increase the number of entities registered under the Controlled Substances Act (CSA) to grow (manufacture) marijuana to supply legitimate researchers in the United States.”
That announcement prompted dozens of applicants to apply with the agency for federal licensure. Yet, in the ensuing 36 months the agency has failed to affirm, deny, or even evaluate the merits of even a single applicant.
Moreover, in May of 2018, the agency appeared to reverse course yet again, when former DEA Administrator Robert Patterson again questioned whether licensing additional, private applicants would be inconsistent with the nation’s anti-drug treaty requirements.
Then in June, one of the applicants seeking a DEA cultivation license — the Scottsdale Research Institute — filed a petition in the US Court of Appeals for the District of Columbia seeking a writ of mandamus to order the agency to comply with its 2016 policy.
Petitioners argued that the DEA’s failure to review their client’s application over a period of several years constituted an unreasonable and undue delay. On July 29, the Appellate Court ordered the DEA to provide a written response to the filing within 30 days. Today’s latest DEA announcement comes just days prior to the closing of this 30-day window.
So, should we take the DEA’s pledge seriously this time? Arguably, the answer is no. Notably, the agency’s latest pronouncement provides no time-table for action, and in fact, lays the groundwork for even further delays.
It states, “Before making decisions on these pending applications, DEA intends to propose new regulations that will govern the marijuana grower’s program.” That’s right — the agency is proposing new rules three-years after it failed to act on its old rules. Meanwhile, the fate of the 33 applications before the agency continues to sit in limbo, and scientific progress continues to be unnecessarily stifled.
In an era where public and scientific interest in the cannabis plant, particularly with regard to its therapeutic properties, has never been greater, the existing hurdles to marijuana research are an artifact of a bygone era.
In the interest of public health, the longstanding monopoly on the growing of cannabis for FDA-approved research ought to be abolished. Yet, despite past promises, there is as of yet no indication that the DEA is serious about following through on this pledge in an expeditious manner. This failure is unacceptable and, as a result, Congress should step in and take legislative action to correct this failed policy.
Paul Armentano is the deputy director of the National Organization for the Reform of Marijuana Laws (NORML). He is the co-author of the book, Marijuana Is Safer: So Why Are We Driving People to Drink? and author of The Citizen’s Guide to State-By-State Marijuana Laws.