Prof. Craker v. DEA: MAPS Challenges Federal Manipulations of Science

MAPS Bulletin Winter 2007: Vol. 17, No. 3 MAPS Fiscal Report

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As many of you are aware, on February 12, 2007, DEA’s own Administrative Law Judge (ALJ Bittner) recommended that DEA grant Professor Lyle Craker’s application for a license to manufacture marijuana at the University of Massachusetts-Amherst for use exclusively in government-approved research. The facility would be funded by a grant from MAPS; ALJ Bittner focused on the fact that the proposed facility would be in the public interest, and that NIDA’s monopoly is “unjustified.” Unfortunately, DEA is not bound to follow the ALJ’s decision.

Currently, in order to gain access to research materials to test marijuana’s safety and efficacy, scientists in the US must petition the National Institute on Drug Abuse and demonstrate the merits of their protocol–after these merits have already been considered and approved by FDA. There is no other drug, legal or illegal, for which this is the case. Under NIDA policy, marijuana’s efficacy as a medicine is not a meritorious subject for study, and therefore researchers who include efficacy measures in their protocol are denied access to research materials. Since there is no alternative source for research-grade marijuana, NIDA’s monopoly has effectively blocked FDA drug development research for decades. Professor Craker’s proposed facility hopes to provide an independent source of supply, which is the key prerequisite for MAPS’ plan to conduct the clinical research necessary to develop marijuana into a legal, prescription medicine.

Over the past six months, MAPS has teamed up with Americans for Safe Access, the Marijuana Policy Project, the Drug Policy Alliance, and other allied organizations to gain support for the facility from lawmakers, and medical and scientific organizations. The purpose of this campaign is to compel DEA to license Professor Craker as a bulk manufacturer of research-grade marijuana. DEA is an administrative agency, which officially is under the direction of the Executive branch of the Federal Government; DEA’s budget is determined by Congress, and is therefore accountable to both the House and Senate. Pressure from the House of Representatives can affect policy decisions made by DEA, and oversight hearings are often held to look at the agency’s agenda.

In July, the House Subcommittee on Crime, Terrorism, and Homeland Security held a hearing entitled “The Drug Enforcement Agency’s Regulation of Medicine,” under the direction of Subcommittee Chairman Bobby Scott (D-VA). Thanks in no small part to the assistance of Americans for Safe Access, the ACLU, and the efforts of several other organizations, the issues surrounding supply of researchgrade marijuana were addressed by both Chairman Scott and Representative Jerrold Nadler (D-NY). Mr. Nadler hammered DEA’s Joseph Rannazzisi and ONDCP’s David Murray as to why DEA has done nothing but drag its feet since Professor Craker’s application was originally submitted in 2001. In addition, Mr. Nadler illustrated why it is so important that DEA license the facility: “[NIDA’s] basically cut off medical research with respect to marijuana.” Finally, Mr. Nadler demanded a commitment from DEA that a final decision be made before the end of the current administration.

On September 17, a letter of support for the facility signed by 45 members of the US House of Representatives was sent to DEA Administrator Tandy. For PDF of the letter, see: By the time this issue goes to press, a similar letter of support signed by over 35 medical, scientific, and political organizations will have been sent to Administrator Tandy.

We anticipate that several Senators will send a similar letter of support in Spring, 2008. We have already gained support from Massachusetts Senators Kennedy and Kerry, and are targeting a handful of Republicans from medical marijuana states. In the coming months, your voice will be desperately needed to convince Senators to sign the letter of support for Professor Craker’s proposed facility. Keep your eyes open for an action alert!