Three years ago the DEA said they would remove roadblocks to cannabis research — they still haven’t
In August 2016, the agency announced that it had a adopted a new policy “to increase the number of entities registered under the Controlled Substances Act (CSA) to grow marijuana to supply legitimate researchers in the United States.”
This policy change is necessary and long overdue. That is because under federal regulations dating back to the late 1960s, only a single licensed entity – the University of Mississippi — is permitted to cultivate cannabis for clinical research purposes.
This monopoly has stifled clinical investigations into the marijuana plant. Notably, the cannabis grown by the university is often of poor quality and typically fails to reflect the wide variety of strains and products commonly used by the general public.
Specifically, a research analysis published earlier this year by investigators at the University of Northern Colorado reported that the program’s marijuana strains more closely resemble industrial hemp (a low-THC variety of the plant grown for fiber content) than the varieties of cannabis commonly available in dispensaries throughout the country.
According to the program’s current marijuana menu, no available samples contain more than seven percent THC and all samples contain less than one percent CBD — a therapeutic compound of growing interest to scientists, and which has already been developed in an FDA-approved medicine by a British pharmaceutical company. (Great Britain, unlike the United States, licenses private entities to grow marijuana for clinical research purposes and for drug development. Other countries, including Canada and Israel, do so as well).
Moreover, U-Miss’s “research-grade” marijuana is only available to scientists in the form in rolled cigarettes. Marijuana-infused oils, edibles and capsules — items that are now commonplace in both medical and adult-use states — are not available to investigators absent explicit permission from the DEA to import such products from countries outside of the United States.
Scientists wishing to better study the effects cannabis plant in controlled human trials have long been aware of these onerous hurdles, which often discourage many investigators from engaging in such activities.
Similarly, the DEA is also well aware of program’s shortcomings and how these regulatory hurdles limit scientific discovery into the cannabis plant. In fact, the agency highlighted the reality that the single grower system does not adequately meet existing demand, nor does it allow for commercial product development in their August 2016 statement.
[U]nder the historical system, there was no clear legal pathway for commercial enterprises to produce marijuana for product development. In contrast, under the new approach explained in this policy statement, persons may become registered with DEA to grow marijuana not only to supply federally funded or other academic researchers, but also for strictly commercial endeavors funded by the private sector and aimed at drug product development. Likewise, under the new approach, should the state of scientific knowledge advance in the future such that a marijuana-derived drug is shown to be safe and effective for medical use, pharmaceutical firms will have a legal means of producing such drugs in the United States.
Nonetheless, the so-called “historical system” still remains fully in place. Despite having received more than two-dozen applications from private manufacturers seeking DEA licensure to cultivate cannabis, the agency has yet to take action to either affirm or deny a single request.
Moreover, in May of 2018, former DEA Administrator Robert Patterson appeared to walk back the DEA’s 2016 pronouncement when he testified that licensing additional, private applicants may be inconsistent with international drug treaty obligations. This past May, a coalition of lawmakers sent a letter to the DEA and U.S. Attorney General William Barr demanding to know: “What steps have DEA and DOJ taken to review the  cannabis manufacturer applications currently pending? What are the reasons these applications have not been approved?”
Predictably, neither the agency nor the attorney general have yet to provide any answers.
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, and the DEA and the Justice Department should move expeditiously to follow through on their promise to facilitate scientific studies on marijuana and its effects. Further failure to act is unacceptable and any future delays on the part of these agencies should warrant swift and immediate action by Congress.
Paul Armentano is the deputy director of the National Organization for the Reform of Marijuana Laws. He is the co-author of “Marijuana Is Safer: So Why Are We Driving People to Drink?” and author of “The Citizen’s Guide to State-By-State Marijuana Laws.”
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