Lawsuit Filed Against the DEA and Attorney General to Compel Issuance of Licenses to Manufacture Marijuana for Clinical Trials and Potential FDA Approval

  • On the heels of United Nations’ Commission on Narcotic Drugs removal of medical marijuana from the list of most dangerous drugs, lawsuit demands processing and approval of licenses to support research into medicinal properties
  • Efforts to conduct meaningful research into cannabis medicines have been blocked for decades; the continued obstruction is causing suffering for people with serious conditions
  • Mounting evidence of medical benefit and rapidly expanding access to medical marijuana through state regulation suggest eventual FDA approval of botanical cannabis medicine is inevitable
  • The DEA has failed to process more than 30 outstanding license applications for over 4 years despite administrative guidance; the DEA’s announced plans; and the support of scientists, Senators, and NIDA

Boston, Mass, December 3, 2020 – Nearly 20 years after Dr. Lyle Craker of the University of Massachusetts – Amherst first applied for a license to develop a consistent, reliable pharmaceutical cannabis 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 U.S. 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 contravention of its own administrative guidance. Dr. Craker, supported by the Multidisciplinary Association for Psychedelic Studies (MAPS), has filed a lawsuit in the U.S. District Court in Massachusetts to compel the Drug Enforcement Administration (DEA) 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.

M. Allen Hopper, Esq., who has spent much of his 20+ year legal career fighting unjust and irrational drug laws, first represented plaintiff Lyle Craker in his battle to end the NIDA monopoly and remove obstacles to marijuana research and access in 2005. Mr. Hopper is one of the lawyers who filed today's lawsuit. “The strawman of United Nations sanctions has been removed along with all other legitimate objections,” Hopper says “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.”

Rick Doblin, Ph.D., Founder and Executive Director of MAPS, notes that “Twenty years ago, our drug development trials for MDMA-assisted psychotherapy for PTSD began and we will soon seek final approval for that treatment. 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. It's hard to imagine the scope of suffering that people have had to endure because politics and fear override science for prohibition-minded officials like the Attorney General.”

The Controlled Substances Act mandates that all manufacturers of cannabis, a Schedule I substance, be licensed by the Drug Enforcement Administration. Since 1968, the sole federal license to provide cannabis for clinical research has been held by the University of Mississippi and supervised by the National Institute on Drug Abuse (NIDA). Though limited opportunities have been granted to conduct clinical trials, researchers broadly agree that the marijuana provided through the licensee is unfit for research due to 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.

Furthermore, NIDA marijuana is only for permitted for use in research and not for commercial sales; therefore, it cannot be used in FDA-regulated Phase 3 studies which must be conducted with the exact drug, manufactured under Good Manufacturing Processes, that would be marketed. Additional licenses would allow for robust research into marijuana’s potential for mental health conditions, life-threatening illnesses, and use by children with serious chronic conditions such as epilepsy. More than 30 outstanding license applications – including Dr. Craker’s – have not been granted despite growing evidence of medical benefit; administrative law findings; the DEA’s announced plans; and the support of scientists and organizations, Senators, the United Nations, and NIDA itself.

Sue Sisley, M.D., is a cannabis researcher whose efforts to conduct pending MAPS-sponsored cannabis research for Phase 3 trials have been hamstrung. “MAPS has been dismantling onerous barriers to cannabis research on behalf of scientists who could neither conduct good research under the NIDA monopoly nor criticize it for fear their other research would be threatened. The only way to create a level playing field for cannabis medicines is to finally allow access to real-world flower that represents the diverse varieties that are readily available throughout the nation’s regulated markets.”

Upon approval of licenses, it is anticipated that clinical trials to assess the safety and efficacy of cannabis will be initiated for dozens of conditions. If granted a license, Dr. Craker will partner with MAPS and seek to develop marijuana medications to be available through its wholly-owned subsidiary, MAPS Public Benefit Corporation (MAPS PBC).

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ABOUT MAPS

Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. Since its founding, MAPS has raised over $100 million for psychedelic therapy and medical marijuana research and education.