DEA Lawsuit Overview

MAPS is seeking to developing the plant form of marijuana into a prescription medicine for the purpose of making medical marijuana legally available on a federal level. If marijuana were a U.S. FDA-approved prescription medicine, it would no longer 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.

To date, the FDA has not evaluated marijuana as part of a prescription drug-development process. The National Institute on Drug Abuse’s monopoly on the supply of marijuana for federally approved research is in the way.

Prior to initiating a full drug development research program for medical marijuana, MAPS must obtain an independent source of marijuana that is legal for clinical research.

NIDA does not have a monopoly on any other Schedule I drug, such as MDMA, LSD, or psilocybin. NIDA only makes its marijuana available to projects it approves.

MAPS, in association with Professor Lyle Craker of the University of Massachusetts-Amherst Department of Plant and Soil Sciences has been locked in a decade-long struggle to obtain DEA permission to establish a marijuana-growing facility for FDA-approved research, and to end NIDA’s monopoly. On April 15, 2013, the U.S. First Circuit Court of Appeals upheld the DEA’s rejection of the 2007 DEA Administrative Law Judge recommendation that it would be in the public interest for the DEA to license Prof. Craker to grow marijuana under license to MAPS for federally regulated research, thereby ending the NIDA monopoly on marijuana for research. Following the First Circuit decision, Prof. Craker’s legal team decided that the Court acted within its jurisdiction and that there was no point in appealing the case to the U.S. Supreme Court.

Click here to view the complete timeline of MAPS’ medical marijuana research efforts.

MAPS’ current strategy to obtain FDA approval for medical marijuana depends on importing medical grade marijuana into the U.S. for FDA-approved studies. However, as of May 2013, there is no source of medical grade marijuana available for import. Perhaps in several years, medical grade marijuana will be available for import from Israel or Canada or elsewhere enabling MAPS to finance clinical research to develop marijuana into an FDA-approved prescription medicine.

If successful, MAPS would bring smoked and/or vaporized marijuana to market under a nonprofit pharmaceutical model similar to the Population Council’s development and distribution of RU-486.

Note: Despite NIDA’s obstructionism, MAPS has been able to provide some analytical data about marijuana vapor produced by vaporizers to Donald Abrams, M.D., of the University of California, San Francisco. He has used this data as part of his successful application to the FDA to conduct a study evaluating the effects of marijuana on human subjects, cannabinoid blood levels, and carbon monoxide levels in subjects who smoke marijuana and those who use a vaporizer.