The Drug Enforcement Administration (DEA) has become notorious for failing to cooperate in enabling progress in the field of medical marijuana research to happen.
It only seems right that they are hit with another lawsuit regarding the issue. On December 3rd last year, the Multidisciplinary Association for Psychedelic Studies (MAPS) published a press release about a lawsuit targeting the DEA as well as the Attorney General to “compel issuance of license to manufacture marijuana for clinical trials and potential FDA approval”.
The lawsuit of MAPS states that “efforts to conduct meaningful research into cannabis medicines have been blocked for decades; the continued obstruction is causing suffering for people with serious conditions.” This is because the DEA has ignored pleas to process over 30 existing applications to research cannabis for over for years now. The press release adds: “Nearly 20 years after Dr. Lyle Craker of the University of Massachusetts – Amherst first applied for a license to develop a consistent, reliable pharmaceutical product to address the needs of patients with serious illnesses. Despite broad public support for legal, regulated access to medical marijuana, as well as new DEA policy pronouncements and an opinion by the US Department of Justice that the Agency refused to publicly disclose, the DEA has continued to prevent the processing of license applications in violation of the Administrative Procedures Act and the contravention of its own administrative guidance. Dr. Craker, supported by the Multidisciplinary Association for Psychedelic Studies (MAPS), has filed a lawsuit in the US District Court in Massachusetts to compel the Drug Enforcement Administration to end their delay and process marijuana producer and manufacturer license applications thereby allowing sanctioned scientific research toward a viable medical cannabis pharmaceutical product to proceed.”
Dr. Craker’s application to manufacture marijuana officially for the DEA back in 2001 was denied, and according to the DEA they claim that they didn’t have the authority to give it the green light to approve more processors after the University of Mississippi. However, they changed their mind in 2016 and Dr. Craker resubmitted the application.
It’s no secret that the only cannabis available for official use on research is provided by the University of Mississippi and NIDA, which is notoriously low in quality. The lawsuit also states that this marijuana is unfit for research because of “poor quality, unstable supply, and limited variability that in no way emulates the types of cannabis currently available through either state-regulated markets or informal markets where regulated supply is unavailable.” What makes it worse is that this cannabis is only allowed for research and not to be sold commercially, which means that it can’t be used for Phase 3 studies of the FDA, required under the Good Manufacturing Processes.
“Had Dr. Craker’s initial application in 2001 been processed appropriately, marijuana medicines would now be available through pharmacies, regardless of state law, with the strict safety protocols and dosing regularity people with compromised immune systems and serious illnesses need,” says Rick Doblin, MAPS Executive Direct, in a press release. “It’s hard to imagine the scope of suffering that people have had to endure because politics and fear trump science for prohibition-minded officials like the Attorney General.”
“The medicinal use of marijuana is a public health issue that is vital to the wellbeing, health, and safety of millions of Americans,” states the lawsuit, adding further that the US government continues to keep its view that it has no medicinal value while blocking any further research that can prove the opposite.
“Rather than disclosing the shutdown or delays to the public or the applicants or their supporters in Congress – and rather than denying the applications for registration on the basis of the OLC Memorandum to permit judicial review – Department of Justice and DEA disclosed nothing and simply sat on the pending applications with no agency action or explanation,” says the lawsuit.
MAPS says that if licenses are approved, “it is anticipated that clinical trials to assess the safety and efficacy of cannabis will be initiated for dozens of conditions.” Craker intends to work with MAPS to develop cannabis-based medicines that will be made available through MAPS Public Benefit Corporation, a wholly-owned subsidiary of the organization.
“The strawman of the United Nations sanctions has been removed along with all other legitimate objections,” explains Allen Hopper, Esq., who represents Craker. “With this legal action we are simply asking the DEA and the Attorney General to follow the law- and their own publicly-announced plans to process these applications – by ending this absurd obstruction of clinical research with cannabis. Most Americans have access to a vast array of medical marijuana products through state-regulated systems but lack sufficient clinical research to guide their choices and their healthcare providers’ recommendations.”
The lawsuit comes shortly after the United Nations Commission for Narcotic Drugs voted to green light the WHO recommendation, suggesting to remove cannabis as well as cannabis resin from the Schedule IV of the 1961 Single Convention on Narcotic Drugs.
Last May, the DEA was slammed with a lawsuit filed by veterans and scientists who said that the DEA keeping cannabis as a Schedule 1 substance in the Controlled Substances Act was an unconstitutional act, adding that a review should be made to reject rescheduling petitions that were filed in 1992, 2016, and 2020. However, the DEA did nothing but asked the court to dismiss it though their request was denied in August. According to judges, the request was “denied without prejudice to renewing the arguments in the answering brief.”
The DEA has several lawsuits already from the past, so this comes to no surprise – it seems that the least we can expect from them is cooperation to make things go as they should, do what’s right, fair, and just but even that they can’t seem to do.