MAPS Efforts to Obtain a DEA License for a Medical Marijuana Production Facility
Category: Medical Marijuana
Beginning in 1992, MAPS began to try to develop the plant form of marijuana, smoked or vaporized, into an FDA-approved prescription medicine legally available on a federal level and covered by health insurance. If marijuana were a an FDA-approved prescription medicine, it would no longer only be up to individual states to decide on the legal status of medical marijuana. Nationwide, any person with a doctor’s prescription would be legally allowed to use the medicine.
In August 2016, MAPS finally was able to start its first Phase 2 medical marijuana drug development study, investigating the use of four different kinds of marijuana (12% THC/ <1% CBD, 12% CBD/<1% CBD THC, 9%THC/9%CBD, and placebo, in 76 US veterans with chronic, treatment-resistant PTSD. MAPS has obtained a $2.15 million grant for this study from the Colorado Department of Public Health and Environment.
To date, neither MAPS nor any other sponsor has conducted Phase 3 multi-site studies of marijuana as part of a drug development research process. The National Institute on Drug Abuse’s monopoly on the supply of marijuana for federally approved research, in existence from 1968, was in the way since NIDA marijuana can only be used for research, but not for prescription sales. As a result, NIDA marijuana would not be accepted by FDA for use in Phase 3 studies that must use the exact same drug in research for which approval for prescription sales is being sought.
On August 11, 2016, the 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. This decision marks a decisive turning point our partnership with Prof. Lyle Craker of the University of Massachusetts-Amherst, begun almost 17 years ago in 1999, to end the National Institute on Drug Abuse (NIDA) monopoly on the supply of marijuana for research.
On July 25, 2018, United States Attorney General Jeff Sessions received a formal letter from eight U.S. Senators advocating for an end to the NIDA monopoly on research-grade marijuana.
On September 10, 2018, political activist Grover Norquist of Americans for Tax Reform sent a formal letter to United States Attorney General Jeff Session that explains why he is advocating for an end to the NIDA monopoly on research-grade marijuana.
On May 22, 2020, MAPS submitted a public comment to the Drug Enforcement Administration (DEA) in response to new rules proposed by DEA to govern their review and approval/rejection process for applications seeking permission to cultivate and provide marijuana for medical research and FDA drug development efforts.
On December 2, 2020, Dr. Lyle Craker, supported by the Multidisciplinary Association for Psychedelic Studies (MAPS), 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. Prof. Craker now expects that DEA will finally just say yes to his new application to DEA to grow marijuana.
Click here to view the complete timeline of MAPS’ medical marijuana research efforts.
Click here to view the complete timeline of MAPS and Prof. Craker's DEA lawsuit.
- Official Statement from DEA About Eliminating Federal Monopoly on Marijuana for Research
- 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