Ending the DEA-Imposed NIDA Monopoly, Support Access to Marijuana for Research Support for a Privately Funded Medical Marijuana Research Facility
UMASS-AMHERST MEDICAL MARIJUANA RESEARCH FACILITY
BACKGROUND IN SUPPORT OF AN INDEPENDENT, PRIVATELY FUNDED SOURCE OF PRODUCTION
On February 12, 2007, DEA Administrative Law Judge (ALJ) Mary Ellen Bittner issued an Opinion and Recommended Ruling determining that DEA should grant the application of Professor Lyle Craker, University of Massachusetts-Amherst, for a Schedule I license to grow marijuana for distribution exclusively to federally approved researchers. Prof. Craker's proposed production facility would resolve the controversy over medical marijuana by determining whether it meets the FDA's standards for safety and efficacy.
Unfortunately, DEA is under no obligation to accept Judge Bittner's administrative ruling.
What is at issue?
Should DEA grant a Schedule I bulk manufacturer license to Prof. Lyle Craker, Director, Medicinal Plant Program, Dept. of Plant, Soil and Insect Sciences, UMass Amherst, to establish a privately funded facility to produce marijuana exclusively for federally approved and privately funded research?
What is the problem?
Despite the fact that federal law clearly requires adequate competition in the manufacture of Schedule I and II substances, since 1968 the National Institute on Drug Abuse (NIDA) has had an unjustified monopoly on the production of marijuana for legitimate medical and research purposes in the US; however, NIDA stated in the 2015 that it does not wish to remain the sole supplier and encouraged additional agencies be licensed to do so. However, the DEA imposes the NIDA monopoly by refusing to grant competitive licenses for marijuana production.
Currently, the only way for marijuana to be evaluated by the FDA to determine whether it meets the standards necessary to become a medicine under federal law is for privately-funded sponsors to conduct FDA-approved clinical trials. Unfortunately, NIDA's monopoly on the supply of legal marijuana is a fundamental obstruction to such privately funded research, which is currently not being conducted despite strong public interest.
The DEA wants to have it both ways, denying that marijuana is a medicine because the FDA has not approved it, while simultaneously blocking the appropriate administrative channels which would facilitate FDA clinical trials.
Arbitrary and Lengthy Delays: Despite the fact that it is not NIDA's mission to study the medicinal uses of marijuana or to advocate for such research, NIDA's monopoly on the supply of cannabis available for research results in arbitrary and lengthy delays. For example, Chemic Labs, a DEA-licensed analytical lab, was made to wait more than two years for a reply to its initial request to purchase 10 grams of marijuana for privately sponsored research into vaporizers, a non-smoking delivery system which the Institute of Medicine report recommended be developed. After two years of delay, the application was rejected. NIDA has also refused to provide marijuana to two other privately sponsored, FDA-approved protocols that sought to evaluate marijuana for AIDS wasting syndrome (IND #43-542) and for migraines (IND #58-177).
What is the resolution?
Congress should support and encourage DEA to accept the February 2007 Opinion and Recommended Ruling of Administrative Law Judge Mary Ellen Bittner. Furthermore, DEA should grant a Schedule I bulk manufacturer license to Prof. Lyle Craker, UMass Amherst, to establish a privately funded facility to produce marijuana exclusively for federally approved and privately funded research.
In This Section
On February 5, 2009, Congressman John Olver, along with 15 other Congressmen and –women, sent a letter to Attorney General Eric Holder urging the Attorney General to grant Professor Craker’s request for opportunity to respond to new officially noticed evidence and motion for reconsideration.
A letter from administrators at University of MA to Senator Kennedy supporting Professor Craker's application.
The ACLU's final filing summarizing arguments made on behalf of Professor Lyle Craker's application to the DEA to grow research grade marijuana for use by other scientists in FDA-approved studies of marijuana's medical value.
The government's final filing summarizing arguments made in opposition to Professor Lyle Craker's application to the DEA to grow research grade marijuana for use by other scientists in FDA-approved studies of marijuana's medical value.
Only eight days before the end of the Bush administration, the DEA issued a ruling rejecting the application of UMass Amherst Professor Lyle Craker for a license to cultivate research marijuana for use by scientists in FDA-approved research. The ruling, which contradicts the recommendation of DEA Administrative Law Judge Mary Ellen Bittner, maintains the unique government monopoly over the supply of marijuana available for FDA-approved research.
U.S. Department of Justice-appointed Administrative Law Judge Mary Ellen Bittner issued an 87-page ruling today in favor of removing the government obstruction to medical cannabis research in the United States. University of Massachusetts-Amherst Professor Lyle Craker has led a six-year struggle to gain a DEA license to grow research-grade cannabis so that studies can be conducted to determine the full extent of marijuana's medical value.
On Monday, September 17, 2007, 45 Members of the House of Represenatives forwarded a letter to DEA Administrator Karen Tandy urging her to accept DEA Administrative Law Judge Mary Ellen Bittner's February 2007 Opinion and Recommended Ruling.