|A DEA Administrative Law Judge is expected to rule imminently on whether the US National Institute on Drug Abuse (NIDA) can maintain exclusive control of the production and distribution of cannabis for clinical research.|
At issue in the case is whether the DEA in 2004 improperly rejected an application from the University of Massachusetts at Amherst to manufacture cannabis for FDA-approved research. The DEA waited more than three years before officially denying the University's request, stating that the establishment of such a facility "would not be consistent with the public interest."
Respondents in the case - the Multidisciplinary Association for Psychedelic Studies (MAPS) and Lyle Craker, director of the UMass-Amherst Medicinal Plant Program are challenging the DEA's denial. Respondents argued in administrative hearings last year that a private production facility is in the public interest (as defined by the US Controlled Substances Act) because it would encourage competition in the marketplace and promote technological and scientific advancement in the field of medicine.
Currently, all federally approved research on marijuana must utilize cannabis supplied by and grown under contract with the US National Institute on Drug Abuse (NIDA). The UMass-Amherst proposal sought to provide clinical investigators with an alternative, independent source of cannabis for FDA-approved clinical trials.
Several US researchers have complained in recent years that the low quality of NIDA-grown marijuana is insufficient to use in clinical studies evaluating cannabis' therapeutic potential. Others have criticized NIDA's unwillingness to provide cannabis for clinical protocols seeking to investigate the drug's medical uses. In 2004, the agency's Director Nora Volkow stated that it is "not NIDA's mission to study the medical uses of marijuana."
Under federal law, even if the DEA's Administrative Law Judge rules against NIDA's marijuana monopoly, DEA head Karen Tandy can still elect to set aside the ruling.
For more information, please contact either NORML Executive Director Allen St. Pierre or Paul Armentano, NORML Senior Policy Analyst, at: (202) 483-5500. Additional background regarding MAPS' administrative law challenge is available online at: http://www.maps.org