AUGUST 11, 2016
Rick Doblin, Ph.D., MAPS Executive Director
Natalie Ginsberg, MAPS Policy & Advocacy Manager
DEA Eliminates 48-Year-Old Monopoly on Research-Grade Marijuana, Clearing Pathway for FDA Approval and Rescheduling
WASHINGTON, D.C. — Today, the Drug Enforcement Administration (DEA) announced their intention to grant licenses to additional marijuana growers for research, thereby ending the DEA-imposed 48-year monopoly on federally legal marijuana. Since 1968, the University of Mississippi, under contract to the National Institute on Drug Abuse (NIDA), has maintained the only facility in the United States with federal permission to grow marijuana for research.
“It’s a complete and total end of the NIDA monopoly! There has been no production monopoly on any other Schedule I substance, like MDMA or LSD—only the cannabis plant. Licensing non-government cannabis producers, and thereby creating a path to FDA approval, will finally facilitate the removal of marijuana from Schedule I, and ultimately allow patients to receive insurance coverage for medical marijuana,” said Rick Doblin, Ph.D., Founder and Executive Director of the Multidisciplinary Association for Psychedelic Studies (MAPS).
MAPS has been working to eliminate this cannabis research blockade since 1999. NIDA’s marijuana is eligible for research, but cannot be sold as a prescription medicine, making it unacceptable to the Food and Drug Administration (FDA) for use in future Phase 3 studies. Ending the monopoly finally allows for a pathway to FDA approval for marijuana, which would thereby trigger rescheduling.
In 2001, MAPS partnered with University of Massachusetts-Amherst Professor Lyle Craker, Ph.D., to apply for a DEA license and end the monopoly. In 2007, after years of bureaucratic delays and lengthy legal hearings, a DEA Administrative Law Judge (ALJ) recommended that it would be in the public’s interest to grant Craker the license. In 2009, after almost two more years of delays and less than a week before the inauguration of President Obama, former DEA Administrator Michelle Leonhart rejected the ALJ recommendation. In 2011, Craker sued the DEA in the U.S. First Circuit Court of Appeals. In its 2013 decision, the Court uncritically accepted the DEA’s arguments that NIDA’s monopoly provided “an adequate supply produced under adequately competitive conditions.”
Since the 2013 decision, Craker’s argument that NIDA does not have an adequate supply has become significantly more apparent. NIDA has been unable to provide the strains requested for MAPS’ long-delayed Phase 2 clinical trial of smoked marijuana to treat symptoms of posttraumatic stress disorder (PTSD) in 76 U.S. veterans. As a result, the study is proceeding with lower potency marijuana than what MAPS researchers requested.
The DEA has previously claimed that U.S. international treaty obligations under the United Nations Single Convention on Narcotic Drugs (Single Convention) require a federal monopoly, but in April 2016, the State Department released a statement clarifying that the Single Convention does not in fact limit the number of U.S. marijuana producers.
Furthermore, the DEA’s 2009 rejection of the ALJ recommendation to license Craker relied heavily on a U.S. Department of Health and Human Services (HHS) protocol review process, which was eliminated in 2015.
MAPS’ upcoming Phase 2 clinical trial of marijuana for PTSD in veterans is in collaboration with investigators in Phoenix, Arizona, and at Johns Hopkins University, the University of Colorado, and the University of Pennsylvania. The study is funded by a $2.15 million grant to MAPS from the State of Colorado. The study has received full regulatory approval, and will be the first randomized controlled trial of whole plant marijuana as a treatment for PTSD.
Founded in 1986, MAPS is a non-profit research and educational organization working to evaluate the safety and efficacy of botanical marijuana as a potential prescription medicine for specific medical uses approved by the FDA.
- Official Statement from DEA
- 2007 DEA Administrative Law Judge Findings
- 2013 First Circuit Court Decision
- 2015 HHS Statement Ending PHS Protocol Review
- Legal analysis to be submitted in support of Craker’s new application
Additional information can be found at maps.org/research/mmj/dea-license.