Washington, DC: Administrative hearings began this week at the US Drug Enforcement Administration (DEA) to determine if the agency improperly denied a request from the University of Massachusetts at Amherst to cultivate cannabis for private, federally approved clinical research.
The application – filed with the DEA in June of 2001 by Lyle Craker, director of the UMass-Amherst Medicinal Plant Program, in association with the Multidisciplinary Association for Psychedelic Studies (MAPS) – requested a federal license to cultivate cannabis at the University for FDA-approved research. Currently, all federally approved research on marijuana mustutilize 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. In recent years, several US researchers have complained that the low quality of NIDA-grown marijuana is insufficient to use in clinical studies evaluating cannabis’ therapeutic potential. Others have questioned NIDA’s willingness 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.”
The DEA rejected Craker’s application in December of 2004, stating that the establishment of such a production facility “would not be consistent with public interest.”
In testimony this week before DEA Administrative Law Judge Mary Ellen Brittner, legal counsel for the respondents argued that the establishment of the proposed UMass-Amherst cannabis production facility is in the public interest because it would encourage competition in the marketplace and promote technological and scientific advancement in the field of medicine. “The DEA’s refusal to permit me to grow marijuana for research necessarily prevents an accurate assessment of this plant’s potential medical properties,” Craker said.
NORML Board Member Rick Doblin, head of MAPS, testified that the establishment of an independent provider of medical cannabis is necessary in order to conduct the clinical trials required to establish cannabis as an FDA-approved drug. “This lawsuit is really our last hope for trying to take marijuana – whether it’s smoked or vaporized – through the FDA regulatory system,” he said.
Doblin, who described MAPS as a “non-profit pharmaceutical company,” said that his organization’s goal was to bring natural cannabis to market as a FDA-approved medicine. MAPS has previously received an “orphan drug” designation from the FDA for marijuana for the treatment of the AIDS wasting syndrome. Orphan drug status is a designation granted by the FDA to facilitate the development of a prescription drug for rare diseases.
Lawyers for the DEA said that they were unaware of complaints regarding the quality and availability of NIDA-grown marijuana.
Testimony in the case will continue the week of September 26, 2005.
For more information, please contact Paul Armentano, NORML Senior Policy Analyst, at: (202) 483-5500 or visit: http://www.maps.org
Additional background on the case is available online from the American Civil Liberties Union Drug Litigation Project at: http://www.aclu.org/medicalmarijuana