On Monday, the Drug Enforcement Administration announced that it would soon propose new regulations for the cultivation of cannabis for scientific and medical research. It would do so, the DEA said, before responding to pending applications from entities that have long been seeking approval to grow the plant for those purposes.
According to the agency, the proposed regulations will “facilitate and expand” opportunities for researchers, in part by “increas[ing] the variety of marijuana available.” However, given the DEA’s track record, in addition to recent conflicts between the agency and researchers, it remains to be seen when the move to improve the cannabis research landscape in the United States will be carried out.
In the press release, Attorney General William Barr and the acting DEA Administrator Uttam Dhillon said that they “will work with other relevant federal agencies”—including the Department of Health and Human Services—“to expedite the necessary next steps.” However, “To ensure transparency and public participation” in the process, the DEA said it would first provide applicants and the general public with the opportunity to comment on the proposed regulations.
Notably, the DEA’s announcement comes on the heels of a petition filed on behalf the Scottsdale Research Institute in Arizona, which called upon the US Court of Appeals for the District of Columbia Circuit to order Attorney General Barr and the DEA to process its application to cultivate cannabis for clinical research.
Researchers working on clinical trials dealing with cannabis have been running into walls for years, according to Sue Sisley, who heads the Scottsdale Research Institute in Florida. She told Cannabis Wire that, in May, she participated in the FDA’s hearing on cannabis and cannabis-derived compounds, where she shared that the Institute’s next clinical trial will study smoked cannabis flower, in comparison to fentanyl, for relieving pain in late-stage cancer patients. When addressing the FDA, Sisley pointed to a study that she and her colleagues recently completed, which examines four varieties of cannabis for military veterans with PTSD. The study, she said, took her team ten years to complete, all because of “excessive layers of government red tape.”
In 2016, Sisley added, it seemed as though one of those layers would finally be eliminated. That year, the DEA announced that it would license more cannabis growers for research. The Institute, whose research outcomes are shaped and limited by the amount and quality of available government-supplied cannabis, welcomed the move. According to Sisley, the government’s cannabis, which comes from a single farm at the University of Mississippi, “looks more like green talcum powder than medical grade cannabis.” In fact, she added, most of the samples received by the Institute contained extraneous plant materials, like sticks and seeds. Some even had mold. These elements “caused bronchial irritation in some subjects.”
And so, in 2016, when the Institute learned of the possibility of manufacturing “its own, on-site, high-quality, fresh cannabis under the agency’s strict regulations and supervision,” Sisley readily applied. But by mid 2019—more than two years later—the Institute’s application had yet to be approved. Or denied.
Under the Controlled Substances Act’s “Improving Regulatory Transparency for New Medical Therapies Act,” Attorney General Barr has ninety days to respond to these applications. In an effort to get the ball rolling, Sisley says she reached out to the DEA five times. The agency, she told Cannabis Wire, also received “over a dozen bipartisan letters” from members of Congress asking the agency to address her application—all to no avail. Frustrated with the lack of response, Sisley turned to the courts.
On June 11, the Scottsdale Research Institute filed a petition with the U.S. Court of Appeals for the District of Columbia, calling upon Barr, Dhillon, and the DEA itself to make a decision regarding the application. More specifically, Yetter Coleman LLP, the firm representing the petitioner, filed a writ of mandamus—an order from a court to government officials—asking that the court mandate that the DEA and Barr properly fulfill their official duties, or correct an abuse of discretion.
A non-decision, Matthew Zorn, one of the attorneys representing the Institute, explained to Cannabis Wire, is worse than a rejection, which can be appealed. In refusing to respond to the Institute, he added, the DEA “insulated itself to judicial review.”
On July 29, the Court ordered the DEA to provide a written response to the filing within thirty days. According to Zorn, this is what ultimately compelled the DEA to move forward. In a statement, he said, “Today—two days before the DEA’s court-ordered response explaining why it had not processed [the the Scottsdale Research Institute’s] three-year-old application was due in the US Court of Appeals for the DC Circuit—[the] DEA . . . announced it would issue new guidelines to govern registration to grow cannabis for clinical research.”
Zorn also signaled that though Sisley “considers this to be a victory,” she remains “cautiously optimistic.” Because of the lawsuit, he wrote in a statement, the federal “monopoly on growing cannabis appears to be moving toward an end, and the work of conducting robust clinical trials involving medical grade cannabis can finally begin.”
What’s missing from the DEA’s statement, he and others note, is a timeline.
In that joint statement, Sisley added: “Now we just need to keep the DEA’s feet to the fire. It could take years to get access to newly cultivated cannabis material for research—[the]DEA/DOJ can slow-roll this for many years to come, leaving progress of medical cannabis research in limbo indefinitely. But at least that door is now theoretically kicked open.”
NORML’s Executive Director, Erik Altieri, echoed that point. In a statement, however, he said that, “For the past three years, the DEA has failed to take any steps to follow through on its promise to facilitate clinical cannabis research.” The recent announcement, he added, “makes it clear that this foot-dragging will continue.”
To support his claim, Altieri noted that some of the applications “have been pending for more than two years,” and, in its filing in response to the Scottsdale Research Institute’s petition, the agency does not provide any timetable, saying only that it intends to promulgate regulations “that would supersede the 2016 policy statement,” before going on to evaluate the applications “in the near future.” Altieri then pointed to an announcement issued by the DEA in 2016 to illustrate his argument that “this is not the first time the agency has made such a promise.”
In its filing, the DEA also pointed to that announcement and said that, since its publication, “the Department of Justice, in consultation with other federal agencies, has been engaged in a policy review process to ensure that the marihuana growers program is consistent with applicable laws and treaties.” That review process, wrote the agency, remains ongoing. However, the Department of Justice has “determined that adjustments to DEA’s policies and practices related to the marihuana growers program may be necessary.”
In response to a request for a projected timeline for the new regulations, DEA spokesperson Katherine Pfaff told Cannabis Wire via email that the agency does “not have an exact timeline to share on when regulations will be finalized and additional growers will be registered.” When asked what compelled the agency to determine that it needs to propose new regulations, the DEA said that, “Until recently, the demand for research-grade marijuana was limited, and a single grower was sufficient to meet the demand of the research community.” Now, the DEA “believes that it would be beneficial to have additional growers given the increased demand for research-grade marijuana.”
In 2016, when the DEA first suggested new growers would be allowed, a similar reason was given for the change: the “growing public interest in exploring the possibility that marijuana or its chemical components may be used as potential treatments for certain medical conditions.”
