The University of Massachusetts-Amherst (Dr.Lyle Craker, Director, Medicinal Plant Program, UMass Amherst Department of Plant and Soil Sciences) in association with Multidisciplinary Association for Psychedelic Studies (MAPS) is in the midst of the process of seeking DEA permission to establish a medical marijuana production facility to grow high-potency marijuana for FDA-approved research.
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 and denies marijuana even to FDA-approved protocols it doesn’t approve, 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. There have been no US-based privately-funded marijuana production facilities since 1942, when marijuana was removed from the US Pharmacopoeia and its medical use was prohibited.
Dr. Lyle Craker originally submitted the application for a license to DEA in June 2001. In December 2001, DEA claimed it was lost. Subsequently a photocopy was resubmitted but UMASS/MAPS were told in February 2002 that the photocopied application was invalid since it didn’t have an original signature. In July 2002, the original application was returned, unprocessed, with a DEA date stamp showing it had been received in June 2001. Dr. Craker resubmitted the original application to DEA on August 20, 2002, which DEA finally acknowledged receiving.
UMASS/MAPS worked with the Marijuana Policy Project on a Congressional sign-on letter to the DEA expressing support for the UMass Amherst license. The letter was submitted to DEA Administrator Asa Hutchinson on June 6, 2002 (attached).
DEA Administrator Asa Hutchinson responded in a letter to Rep. Barney Frank on July 1, 2002 (attached). DEA questioned whether this new facility would be in the public interest, since NIDA currently grows marijuana for research. In response, MAPS drafted a document explaining why it would be in the public interest for DEA to grant a license for the UMass Amherst facility, and submitted the document to DEA, the Office of National Drug Control Policy (ONDCP) and NIDA.
The DEA has also indicated that granting such a license might conflict with US international treaty obligations, specifically the Single Convention on Narcotic Drugs. In response, UMASS/MAPS worked with Graham Boyd of the ACLU Drug Policy Litigation Project and Peter Barton Hutt and Alexei Silverman, of the DC law firm Covington & Burling, on the development of a legal document detailing why US international treaty obligations do not prevent the licensing of the UMass Amherst facility.
On July 24, 2003, DEA finally filed a notice in the Federal Register about Prof. Craker’s application, with a public comment period ending on September 23, 2003. On October 23, 2003, Senators Kennedy and Kerry wrote a letter to the Administrator of the DEA expressing their strong support for DEA licensing of the facility. UMASS/MAPS expected DEA’s approval or rejection of Dr. Craker’s application sometime before the end of 2003 but that did not occur as DEA delayed any decision as long as possible.
On July 21, 2004, MAPS, Prof. Craker and Valerie Corral filed lawsuits against DEA and also against HHS/NIH/NIDA for obstructing medical marijuana research. On July 29, 2004, MAPS filed a motion to consolidate the lawsuit against the DEA and the lawsuit against HHS, NIH and NIDA. Shortly thereafter, on November 22, 2004, the Court required DEA to respond by December 22, 2004 to the portion of the lawsuit against DEA about the UMass Amherst marijuana production facility.
On December 3, 2004, MAPS mailed petitions for reconsideration to the DC Circuit Court of Appeals, asking again for the Court to pressure HHS and DEA for not responding in 17 ½ months to their applications to purchase 10 grams and import 10 grams, respectively, in both cases for marijuana vaporizer research.
On December 10, 2004, DEA finally rejected the application from Dr. Lyle Craker, UMass Amherst, seeking a license to establish a MAPS-sponsored facility to produce marijuana for federally-approved research, 3 and 1/2 years after the application was initially filed.
On February 28, 2005, DEA filed its pre-hearing statement in the DEA Administrative Law Judge (ALJ) hearing. In DEA’s initial "Order to Show Cause" explaining its rationale for rejecting Prof. Craker’s application, DEA claimed that it would be against the public interest for it to approve the license, and that, in any case, US international treaty obligations prevented DEA from issuing the license.
On April 22, 2005, UMass (Prof. Lyle Craker) filed his pre-hearing statement to the DEA Administrative Law Judge for the hearing with assistance from lead lawyer Julie Carpenter of Jenner & Block, Allen Hopper of the ACLU Drug Law Reform Project, and Emanuel Jacobowitz, Steptoe & Johnson, all working on a pro-bono basis.
On August 15, 2005, Chemic Laboratories received an official letter indicating that NIDA refused to sell it10 grams of marijuana for MAPS-sponsored research into the use of marijuana vaporizers. Chemic Labs had applied to purchase the 10 grams more than two years before.
The initial round of hearings took place August 22-26, 2005, with an additional week December 12-16, 2005, for DEA to present its witnesses
During the August hearings, DEA seemingly abandoned the claim that US international treaty obligations prevent it from licensing Prof. Craker’s facility, with a DEA official testifying on the stand that there is nothing in DEA law or policy that prevents it from licensing individual researchers from growing different strains of marijuana. The central issue remaining is whether it is in the public interest for DEA to license the UMass Amherst facility or whether NIDA should retain its monopoly on supply, a monopoly that clearly obstructs research.
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