For the second time in four years, the U.S. Drug Enforcement Administration is formally proposing regulatory changes to procedures governing the federally licensed manufacture of cannabis for clinical research purposes.
The purported intent of the agency’s new rules is to facilitate clinical investigations of the plant and its active constituents — investigations that are unnecessarily difficult to conduct today because there exists only one federally licensed marijuana provider, the University of Mississippi. But a close inspection of the DEA’s proposed regulations finds that they will likely create more problems than solutions.
Surprised? You shouldn’t be. The DEA possesses an abysmal track record when it comes to enabling scientists to engage in cannabis-specific studies in the United States, in particular research evaluating the plant’s therapeutic efficacy. For instance, in 1988 the agency’s own administrative law judge concluded marijuana to be “one of the safest therapeutically active substances known to man,” and demanded the DEA reclassify the plant so that doctors could prescribe it. The agency set aside the decision and refused to act upon the judge’s order.
In 2007, the agency lost yet another lawsuit. In this case, the judge ruled 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.” Once again, the agency set aside the decision and refused to abide by the judge’s ruling.
Then, in 2016, the agency enacted a revised set of rules explicitly designed to expand the pool of applicants eligible to cultivate cannabis for use in FDA-approved clinical protocols. The move was welcomed by scientists, who have long acknowledged that the cannabis grown by the University of Mississippi is often of inferior quality and fails to accurately reflect the types of varieties commercially available in the United States. Following the issuance of these new rules, dozens of proprietors — including branches of the University of California and the University of Massachusetts — applied to the agency seeking licensure. But to date, the agency has neither accepted nor denied a single applicant.
With such a checkered past, it is easy to see why many remain incredulous that the DEA’s latest actions are in good faith. And a closer look at the new rules provides even more reasons to be skeptical.
For one thing, the proposed changes are woefully impractical. For another, they greatly expand the agency’s power and control over decisions that ought to be best left up to health experts and scientists.
Specifically, the new rules continue to grant the DEA sole discretion to decide which applicants, if any, will be permitted to grow cannabis for research purposes, and it provides no timeline under which the agency must act on the 30+ applications already before it.
Further, the proposed rules mandate the agency to become the sole purchaser of all cannabis produced by federally licensed entities. Yet, nowhere do the rules mandate that the agency pay fair market value for these products, or do they ensure that the DEA purchases them at a price that allows manufacturers to cover their start-up costs — which will no doubt be enormous — or turn a profit.
Moreover, the rules mandate the agency to take ownership of and warehouse all harvested marijuana. But no timeline is provided with respect to where or when this location will be available, and no estimate is provided specifically to the financial expenditures that will be necessary in order to secure it properly.
There is a better way of course. To date, 33 states and the District of Columbia license private entities to commercially produce lab-tested, medical-grade cannabis and cannabis-infused products for qualifying patients. These entities and their manufacturing practices are regulated by state agencies, and their products are representative of the types and varieties of cannabis currently consumed by the public.
Rather than compelling scientists to access marijuana products of questionable quality manufactured by a limited number of federally licensed producers, federal regulators should allow investigators to access the cannabis that is currently being produced by the multitude of state-sanctioned growers and retailers throughout the country.
Last year, Maryland lawmakers became the first in the nation to sign such a measure into law. Other states should do likewise and federal lawmakers ought to encourage regulators, including the FDA, to embrace these plans. Doing so would not only facilitate clinical cannabis research in the United States, but it would also bring about a long-overdue end to decades of DEA-stonewalling and empty promises.
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.