At present, the National Institute on Drug Abuse (NIDA) has a monopoly on the supply of marijuana that can be used in research, seriously hindering medical marijuana research. NIDA provides inferior, low-potency marijuana to researchers whose protocols it approves. NIDA has denied marijuana to FDA-approved protocols, including two sponsored by MAPS, preventing those studies from taking place.
No privately funded sponsor (such as MAPS, or alternatively, a for-profit pharmaceutical company) will invest significant sums in a realistic drug development research program aimed at obtaining FDA approval for the prescription use of marijuana without first obtaining its own independent source of supply of a drug whose quality, price and availability it determines. As far as we can tell, there has been no US-based privately-funded marijuana production facility since 1942, when marijuana was removed from the US Pharmacopoeia and its medical use was prohibited.
We have been involved in a long and daunting legal challenge with DEA to get a license to grow marijuana for Dr. Lyle Craker. Dr. Craker originally submitted the application for a license to DEA in June 2001. Six years later on February 12, 2007, after numerous court hearings and legal struggles, DEA Administrative Law Judge Mary Ellen Bittner presented a recommended ruling on our behalf to the DEA. Judge Bittner stated that it was in the public’s interest to end the monopoly on the supply of marijuana for research. In December of 2007, we completed a congressional sign-on letter campaign, gathering signatures from 38 members of Congress for a letter to DEA Administrator Karen Tandy expressing support for the proposed marijuana production facility. We also had the support of Senators Kerry and Kennedy. However, on January 14, 2009 the DEA overruled the recommendation from their judge and ruled against licensing Professor Craker.
On August 15, 2011, the DEA issued its final order rejecting ALJ Bittner’s 2007 recommendation. MAPS, Professor Craker, and his lawyers at the American Civil Liberties Union and Covington & Burling LLP are now suing the DEA in the United States Court of Appeals for the First Circuit.
MAPS Planned Marijuana Production Facility and Legal Challenges
MAPS, in association with Prof. Lyle Craker, Director, Medicinal Plant Program, University of Massachusetts Amherst, Department of Plant and Soil Sciences, has been seeking DEA permission to establish a medical marijuana production facility to grow high-potency marijuana for FDA-approved research.