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DEA Rejects Order To Allow For Private Production Of Marijuana For FDA-Approved Research

Thursday, 15 January 2009

Washington, DC: The US Drug Enforcement Administration (DEA) has rejected a 2007 administrative ruling demanding that the agency license non-government entities to produce cannabis for FDA-approved clinical research.

DEA Deputy Administrator Michele Leonhart said that its own administrative law judge (ALJ) erred when she determined that the agency should grant a license to the University of Massachusetts (U-Mass) at Amherst's Medicinal Plant Program for the purposes of manufacturing research-grade cannabis. The DEA had rejected the U-Mass request in 2004.

In her 2007 decision, DEA administrative law judge Mary Ellen Bittner opined: "I conclude that granting Respondent's application would not be inconsistent with the Single Convention, that there would be minimal risk of diversion of marijuana resulting from Respondent's registration, that there is currently an inadequate supply of marijuana available for research purposes, that competition in the provision of marijuana for such purposes is inadequate, and that Respondent has complied with applicable laws and has never been convicted of any violation of any law pertaining to controlled substances. I therefore find that Respondent's registration to cultivate marijuana would be in the public interest."

The DEA set aside Judge Bittner's ruling in a 118-page decision, issued late last week. Administrator Leonhart contended that international treaty obligations demand a "government monopoly" on the bulk manufacturing and distribution of cannabis. Leonhart also argued that US National Institute on Drug Abuse (NIDA) possesses "adequate" quantities of cannabis to meet the needs of privately funded researchers. (Under current policy, all federally approved research on marijuana must utilize cannabis supplied by and grown under contract with NIDA.)

The DEA further alleged that the non-profit group MAPS (the Multidisciplinary Association of Psychedelic Studies) was ineligible to underwrite the U-Mass project because the organization's director, NORML Board Member Rick Doblin, had admitted using marijuana. Leonhart wrote, "It is simply inconceivable that DEA would ... grant a registration to engage in certain activities involving controlled substances where it is clear that a person who will have any role in the oversight and management of such activities ... engages in the illegal use of controlled substances."

Leonhart concluded: "I have determined that Respondent's proposed registration is inconsistent with United States obligations under the Single Convention and with the public interest. ... Respondent's ... goal of ending the Federal Government's monopoly on the wholesale distribution of marijuana can not be squared with the requirement under the Convention that there be precisely such a monopoly. With respect to the public interest, Respondent's failure to demonstrate that the longstanding existing system in the United States of producing and distributing research-grade marijuana under the oversight of [the US Department of Health and Human Services] and NIDA is inadequate ... weighs heavily against his application. Also, with respect to the public interest, the admitted conduct relating to controlled substances of Respondent's sponsor ... is unacceptable for anyone seeking to have a prominent role in overseeing the controlled substance activities of a DEA registrant. In sum, [these] three independent grounds ... provide a sufficient (indeed compelling) legal basis for denying Respondent's application."

Responding to the DEA's rejection, MAPS Executive Director Rick Doblin said: "The DEA and NIDA, but not the FDA, are clearly frightened of permitting privately-funded, scientific research into the risks and benefits of the medical uses of marijuana. We need the Obama Administration to reverse this egregious suppression of scientific research that the outgoing administration so fears will reveal inconvenient truths." He also added that "this ruling will strengthen efforts to obtain state-level medical marijuana reforms."

The DEA has a history of overruling decisions favorable to the medical use of cannabis. In 1989, former DEA Administrator John Lawn rejected a 1988 ALJ ruling (NORML et al. v. DEA) that determined that cannabis possessed "currently accepted medical value, The United States Court of Appeals for the District of Columbia upheld Lawn's decision in 1994.

For more information, please visit: www.maps.org or: aclu.org/drugpolicy/medmarijuana/





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