U.S, April 24, 2020 (CANNABISBUSINESS) The Drug Enforcement Administration’s draft rules for the program have been met with mixed industry reactions, but Colorado-based MedPharm is encouraged by the progress.
Last month, the U.S. Drug Enforcement Administration (DEA) issued draft rules to regulate the cultivation of cannabis for research purposes in an announcement that was met with mixed industry reactions.
NORML announced April 8 that it had formally submitted comments in opposition of the DEA’s proposed rule changes. The advocacy group criticized the agency for maintaining the sole discretion to choose which applicants will be authorized to grow cannabis for research, and expressed its dismay that the DEA has not provided a timeline for approving pending applications.
“While NORML has long supported facilitating and expanding domestic clinical research efforts, we do not believe that these proposed rules, if enacted, will achieve this outcome,” NORML wrote. “Rather, we believe that the adoption of these rules may further stonewall efforts to advance our scientific understanding of cannabis by unduly expanding the DEA’s authority and control over decisions that ought to be left up to health experts and scientists.”
NORML also suggested in its comments that rather than licensing a new set of growers, the DEA should allow the cannabis already being produced by state-licensed cultivators to be used for federal research.
“Rather than compelling scientists to access marijuana products of questionable quality manufactured by a limited number of federally licensed producers, NORML believes that 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,” the organization wrote. “Doing so would not only facilitate and expedite clinical cannabis research in the United States, but it would also bring about a long overdue end to decades of DEA stonewalling and interference with respect to the advancement of our scientific understanding of the cannabis plant.”
Under the DEA’s existing regulations, the University of Mississippi is the only federally licensed facility permitted to cultivate cannabis for use in FDA-approved clinical trials. In 2016, the DEA announced that it would begin accepting new cultivation license applications, and although the agency received roughly two dozen applications from interested parties, it has not approved or denied a single one.
Last summer, a federal court ordered the DEA to explain why it had not responded to the pending applications after Dr. Sue Sisley and the Scottsdale Research Institute (SRI) filed a lawsuit against the agency and the Justice Department in June. Phoenix-based SRI had applied for a DEA license in 2016 to grow its own cannabis for an ongoing study on medical cannabis as a treatment for veterans suffering from post-traumatic stress disorder (PTSD) after criticizing the poor quality of cannabis available from the University of Mississippi.
In August 2019, the DEA entered a filing in the Federal Register indicating that it would establish regulations to evaluate the applications, and the federal court dismissed Sisley’s lawsuit. Around that same time, some companies with pending cultivation applications received word from the DEA that they had been selected to advance in the application process.
MedPharm, a Colorado-based cannabis research and formulation development company, was one of the companies notified.
Dr. Tyrell Towle, MedPharm’s director of chemistry, is encouraged that the DEA has made good on its promise to promulgate the regulations necessary to review the pending applications and license additional cultivators.
“We’re of course very excited to see movement—any kind of movement—by the DEA to increase the number of suppliers and therefore the variety and competition,” Towle tells Cannabis Business Times.
MedPharm submitted its application in 2016 following the DEA’s initial announcement that it would expand the number of licensed cultivators. Now, three and a half years later, Towle says he is pleased with the rules that the DEA has ultimately proposed for the program.
“We’re very excited to see the draft rules and actually, for the most part, they make quite a lot of sense and we’re very happy with what they’ve come up with,” he says.
The public comment period remains open until May 22, and the MedPharm team plans to submit a response that mostly seeks clarification on the specifics of the rules.
Under the DEA’s proposed regulations, the agency will begin reviewing the applications it has received but will not allow any new applicants into the pool until the pending applications have been dealt with. The agency requests that applicants have potential research partnerships lined up before they are granted final licenses, and Towle says the MedPharm team feels good about their position.
“We are of course seeking partnerships with Schedule I DEA-licensed researchers to see if they are interested in a new source of cannabis that’s much higher quality than what the University of Mississippi is providing,” he says.
MedPharm currently holds a state research license in Colorado, but DEA licensure will allow the company to supply its cannabis and dosage forms to researchers across state lines.
“For researchers, … it’s really exciting because they won’t be limited to getting their cannabis from the University of Mississippi,” Towle says. “They don’t grow every year. They grow, harvest, and then disperse it over time, so it’s not the highest quality and it’s not representative of what people purchase in dispensaries. Researchers will be able to get their hands on materials that more closely represent what people actually have access to in the state-level recreational and medical marketplaces.”
MedPharm also plans to leverage its DEA license to advance its own in-house research projects. One of its studies, for example, focuses on how medical cannabis can help patients with Alzheimer’s disease.
“When we do our Alzheimer’s disease study, in addition to looking at symptoms, we’re going to be looking at blood flow in the brains of these patients over time to see if [there is] increased blood flow in the parts of the brain that are important to Alzheimer’s disease,” Towle says.
MedPharm is also conducting research on whether different cannabinoids affect certain cancer cell lines, he adds.
A DEA license will allow MedPharm to engage a more diverse group of people in clinical trials associated with this research, Towle says.
“To get an FDA-approved drug, you have to experiment on a lot of people through clinical trials, but with many people who are diverse,” Towle says. “We’re not going to get the diversity we need just in Colorado. We need to extend that dosage form across the country to research centers in order to get the patient population we need for that.”
Historically, the federal government has focused its studies on the potential harms of cannabis, Towle adds, and he is encouraged that the DEA seems to be opening up to the idea of looking at the medical benefits of cannabis with the goal of supporting new FDA-approved medications through the research program.
“We’re very excited about what’s coming up in cannabis research,” Towle says. “The cannabis [that researchers] get is so little potency that it probably can’t elicit the medical effects that a higher-potency strain would. … It’s going to be good to see this develop. Hopefully this time next year we have new, freshly licensed cultivators and MedPharm will be one of those.”
