The federal cannabis research logjam finally appears to be moving. For years, one aspiring grower has chipped away at requirements and forms and permissions — all with the hope of being one of the first in line when the Drug Enforcement Administration was ready to issue its first licenses in decades.
As of last week, that federal stamp of approval appears to be imminent, as Cannabis Wire reported.
George Hodgin, founder of Biopharmaceutical Research Company (BRC), talked to Cannabis Wire after the DEA’s announcement that it was “nearing the end of its review of certain marijuana grower applications, thereby allowing it to soon register additional entities authorized to produce marijuana for research purposes.”
“It feels as if we’ve been preparing to run a race. And finally, the gun has gone off,” Hodgin told Cannabis Wire, adding that his “first reaction was an overwhelming sense of relief, excitement.”
Just days before the DEA announcement, against this backdrop of anticipation, the Colorado State University Pueblo’s Institute of Cannabis Research continued its long-running monthly cannabis research series by hosting Hodgin and Ajay Nayak, an assistant professor in the Department of Medicine at Thomas Jefferson University in Philadelphia, who together gave a presentation called “Academic and Business Perspectives of Compliance in Cannabis Research.” Jefferson University houses the Lambert Center for the Study of Medicinal Cannabis & Hemp.
With Hodgin’s active application with the DEA to produce “federally compliant cannabis products for research” and Nayak’s active research grant from National Institutes of Health to “develop diagnostic tools for determining cannabis allergies,” the pair were well-positioned to field questions about the notoriously difficult hoops that cannabis researchers must jump through for federal approvals and grants — and, of course, cannabis supply.
“What I want you to take away from the presentation today is that federally compliant cannabis research is hard but doable. If you go through the appropriate processes, it is doable, although it might seem complex and intimidating at first,” Hodgin said.
Hodgin started with a story about why he turned to compliant cannabis research. As a Navy SEAL veteran, Hodgin said he became interested in cannabis when he got “involved in the healthcare” of a teammate who wanted to use medical cannabis, but his doctor at the Department of Veterans Affairs said that answering questions about medical cannabis was “really challenging” because there’s an “incredible gap in need for meaningful scientific research around cannabis.” And, Hodgin continued, “that’s why we decided to dive right in.”
Hodgin then focused on how an entity can become federally compliant. He pinpointed a major rub for cannabis researchers: “consumers in the US can access state-legal, federally illegal cannabis, but institutions (biotech, pharma, academia and [consumer packaged goods] cannot.” In other words, researchers can’t access the cannabis on, say, Colorado or California dispensary shelves, and they have to get their supply from the federally-approved cannabis farm at the University of Mississippi because it has for decades been the only entity that holds a federal license.
Assuming that cannabis researchers are seeking cannabis or cannabinoids without breaking federal law, there is another option: They can import cannabis from a DEA-approved provider abroad. There is a rising number of countries where the cultivation of cannabis for medicine or research is legal, from Canada to Israel.
“A lot of researchers don’t know that. They just say ‘look, the University of Mississippi may not have the product and inventory that I need. I’m out of luck.’ But in fact, I’m here to tell you that you actually can go through the process to import product from abroad,” Hodgin said.
Another option, Hodgin said, is that researchers partner with a DEA-approved registrant and share resources and data.
A common theme from Hodgin was that while the path to DEA-approval is mired in difficulties and complexities, it’s “well worth” traversing that “well-trodden path.” He laid out some of the agencies from which researchers might need to seek approval: the DEA, the Food and Drug Administration, NIDA, state regulatory agencies, an Institutional Review Board, and perhaps institution-specific controlled substances research departments.
Hodgin said that some researchers rightly think that they’re regulated by federal entities, but sometimes stumble by brushing past the local greenlights.
“What people overlook is that the DEA often considers itself the regulator of last resort, meaning you still have all of your local and state approvals to conduct that research,” Hodgin said. “All of that is to say: engage early and often.”
Nayak said he became more involved in cannabis research when a longtime mentor was approached by a friend who was seeing more patients with allergic reactions to cannabis after various exposures.
“They’re from different walks of life. Some were occupational exposures, some recreational exposures. But nevertheless, we saw that there was some kind of reaction on exposure to the plant. We didn’t really know much about it. You know, we discussed it. If we wanted to go back to this question, how would we pursue that?” Nayak said.
Nayak talked about the difficulties that cannabis researchers face in even trying to develop the question they’re investigating. For example, different questions might require different cannabis research samples, which would, by extension, require different approval processes.
“Cannabis in total is this sort of restricted substance. Cannabis proteins and genetic material are actually not under the [same] limitations, so this was kind of helpful because then we could get protein extracts from the plant shipped to us for analysis,” Nayak said.
Nayak said that his work has shown that the “context of exposure is so relevant to really understanding what allergens are important now because of this question of occupational exposures becoming relevant.”
Nayak has published studies on his National Institute for Occupational Safety and Health-related investigations on the potential workplace hazards that cannabis poses as an allergen, and he said that he’s “committed now to trying to understand the allergies that are relevant from an occupational setting.” (Read Cannabis Wire’s Q&A on what the NIOSH has learned about cannabis workplace hazards.)
“My goal here is to give a sense to researchers, young investigators out there who might be trying to go after a research question that they want to build careers on,” Nayak said.
“If there’s a will, there’s a way,” Hodgin said. “There’s an incredible need for compliant cannabis research right now.”
