April 8, 2020
The National Organization for the Reform of Marijuana Laws (NORML) has formally submitted comments to the US Federal Register opposing the Drug Enforcement Administration’s proposed rule changes governing the federal production and distribution of cannabis for clinical research purposes.
Under existing regulations, the agency only licenses one facility — the University of Mississippi — to cultivate cannabis for use in FDA-approved clinical trials. Researchers have consistently criticized the poor quality of these plants, which they say fail to accurately reflect the varieties of marijuana commercially available in the United States. As a result, the DEA has been encouraged for over a decade to expand the pool of federally licensed cannabis producers — a move that the agency has largely resisted.
In 2016, the agency appeared to reconsider its longstanding policy, and publicly stated for the first time that it would consider additional applicants. To date, however, the DEA has failed to either affirm or reject any of the more than 30 applications it has received. Under the proposed rules issued by the DEA on March 23, the agency continues to maintain 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 DEA must act on the numerous applications already before it.
In its response to the DEA’s proposed changes, NORML writes: “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. 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.”
Specifically, the newly proposed rules expand the DEA’s authority by declaring it to be the only entity legally permitted to purchase, warehouse, and dispense any cannabis grown under a federal license.
NORML’s response concludes: “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. … 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.”
An abbreviated version of NORML’s comments appears here.
ON BACKGROUND: The DEA has consistently discouraged the scientific investigation of cannabis, particularly with respect to its therapeutic properties.
* 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.
* 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. 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.
