The federal monopoly on growing marijuana for research would continue under a contract extension published by the National Institute on Drug Abuse (NIDA) last week.
In a “pre-solicitation non-competitive” notice, the federal agency announced its intent to award a “award a sole source modification” contract to the University of Mississippi—the only facility in the country that’s been authorized to manufacture cannabis products for use in studies since the late 1960s.
The problem, as far as researchers are concerned, is that the quality of the government’s marijuana is inadequate. In fact, a study found that the cannabis it produces is more chemically similar to hemp than marijuana that’s available in state-legal commercial markets. That raises questions about the real-world applicability of studies that rely on NIDA’s supply.
The proposal would extend the university’s contract from March 2021 to 2022, “with a potential option for an additional 12 months.”
The new filing comes as the Drug Enforcement Administration (DEA) has delayed plans to license additional cannabis manufacturers to supply researchers.
“Only one responsible source and no other supplies or services will satisfy agency requirements,” NIDA said in the new notice. That one supplier will continue to be the University of Mississippi, as the agency stipulated that it will not be “providing for full and open competition” in determining who gets to grow the only federally approved cannabis for use in research.
NIDA, whose director conceded that marijuana’s Schedule I status impedes research in congressional hearing last year, said the latest decision to limit its search is based on “market research.”
“This synopsis is not a request for competitive proposals,” the notice says. “However, interested parties may identify their interest and capability to respond to this notice.”
Any responses must be received by December 22.
DEA announced four years ago that it would be expanding the number of marijuana manufacturers for research, but it has yet to act on any of the dozens of applications that it’s received.
One of those applicants, Lyle Craker of the University of Massachusetts at Amherst, recently filed a federal lawsuit that urges the court to order DEA to either approve his application to be a federally registered marijuana cultivator or at least take action on the request so he can appeal if denied.
In a separate legal challenge against DEA, the Scottsdale Research Institute (SRI) alleged that the agency has been deliberately using delay tactics to avoid approving additional marijuana manufacturers.
A court mandated that DEA take steps to make good on its promise, and that suit was dropped after DEA provided a status update.
In March, DEA finally unveiled a revised rule change proposal that it said was necessary due to the high volume of applicants and to address potential complications related to international treaties to which the U.S. is a party. The agency has not yet finalized and enacted the new policy yet, however, leaving existing applicants in limbo.
The same scientists behind that original case filed another suit against DEA in March, claiming that the agency used a “secret” document to justify its delay of approving manufacturer applications.
That was born out when the Justice Department Office of Legal Counsel document was released in April as part of a settlement in the case, revealing, among other things, that the agency feels that its current licensing structure for cannabis cultivation has been in violation of international treaties for decades.
In another recent case, the agency asked a federal court to reject a case calling for a review of its decision not to reclassify marijuana under federal law.
In a brief filed with the U.S. Court of Appeals for the Ninth Circuit, DEA asserted that that suit is invalid because the plaintiffs in the case weren’t the ones to make the ultimately rejected rescheduling request in the first place and, the agency claimed, the petition lacked merit in any case.
Scientists and veterans in that case sued the federal agency in May, arguing that the legal basis DEA has used to justify keeping cannabis in Schedule I of the Controlled Substances Act is unconstitutional. They asked for a review of its decisions to reject rescheduling petitions in 2020, 2016 and 1992.
DEA asked the court to dismiss the suit, but that request was rejected in August. It was “denied without prejudice to renewing the arguments in the answering brief,” the judges said.
In a positive development for reform advocates and researchers, the U.S. House of Representatives passed a bill last week that’s designed to streamline cannabis studies, in part by allowing scientists to access marijuana from state-legal dispensaries and mandating DEA to approve additional research cultivators within a set timeline.