On December 3, 2020, MAPS (Multidisciplinary Association for Psychedelic Studies) issued a press release regarding a lawsuit against the DEA and the Attorney General seeking to enforce licenses to manufacture marijuana for clinical trials and possible FDA approval. We have already written about MAPS and its 35 years of advocacy and collaboration with DEA, and we are huge fans of the nonprofit.
The announcement of this lawsuit follows the vote by the United Nations Commission on Narcotic Drugs (CND) to approve the World Health Organization (WHO) recommendation to remove cannabis and cannabis resin for medical purposes from Appendix IV of the 1961 Single Convention on Narcotic Drugs. The US had already confirmed that it would support the WHO recommendation and published a statement explaining why it voted:
The United States’ vote to remove cannabis and cannabis resin from Appendix IV of the Single Convention while maintaining them in Appendix I is in line with substantial science showing that cannabis itself has continued to develop a safe and effective therapeutic agent from cannabis Public health risks and should continue to be controlled under international drug control conventions. In addition, this move has the potential to stimulate global research into the therapeutic potential and public health effects of cannabis, and to attract additional researchers to the field, including those who may have been deterred by Annex IV cannabis status. [Emphasis added]
The announcement of the lawsuit by MAPS states that[e]Efforts to conduct meaningful research on cannabis medicines have been stalled for decades. Persistent disability causes suffering for people with serious illnesses, ”which indicates the timeliness of this complaint in relation to the recent CND vote. According to MAPS and the lawsuit, the DEA has not processed more than thirty pending applications to develop cannabis for research in more than four years, despite administrative guidelines. In the press release, the nature of the lawsuit is outlined as follows:
Almost 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 meet the needs of patients with serious illnesses. Despite widespread public support for legal, regulated access to medical marijuana, as well as new pronouncements of DEA guidelines and a statement by the U.S. Department of Justice that the agency did not publicly announce, the DEA has been processing license applications that violate the regulations , further prevented the Administrative Procedure Act and violation of its own administrative guidelines. 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 its delay and process sanctioned marijuana maker and maker license applications scientific research towards a viable cannabis medicinal product to continue.
The Controlled Substances Act (CSA) requires manufacturers of all Schedule I controlled substances, including marijuana, to be DEA approved. Currently, and since 1968, the only federal license to provide cannabis for clinical research is owned by the University of Mississippi and overseen by the National Institute on Drug Abuse (NIDA). According to the lawsuit and much-debated opinion across the industry, the marijuana provided by the University of Mississippi and NIDA is unsuitable for clinical research due to “poor quality, unstable supply, and limited variability that in no way mimics the cannabis strains currently available” either available through government regulated markets or through informal markets where no regulated supply is available. “Furthermore, this limited supply of poor quality marijuana is only for permitted research use and is not for commercial sale. This means it cannot be used in FDA regulated Phase 3 studies that need to be done on the exact good manufacturing drug that would be marketed.
The goal of forcing the DEA to process these pending license applications is to allow additional research into the potential medical benefits and uses of marijuana – something that has undoubtedly become a bipartite-backed issue in the U.S. however, it remains difficult to reach through government channels. The results of the November election to approve measures to legalize cannabis in the US in conjunction with the CND’s vote to remove medicinal cannabis from Appendix IV show that the time is near for the DEA to work together to ensure that the medical marijuana research can advance. After all.