GENERAL POLICY ISSUE: Should the controversy over the medical use of marijuana be resolved through FDA-approved scientific research or through legal and political struggles? Should the federal government facilitate or obstruct scientific research?
SPECIFIC POLICY ISSUE: Is it in the public interest for DEA to license Prof. Lyle Craker, Director, Medicinal Plant Program, Dept. of Plant, Soil and Insect Sciences, University of Massachusetts Amherst, to establish a privately-funded facility to produce marijuana exclusively for federally-approved and privately-funded research, or should the federal government, through the National Institute on Drug Abuse (NIDA), retain its unique monopoly on the supply of marijuana that can legally be used in research?
CONTEXT: On June 6, 2005, the US Supreme Court ruled, in Gonzales v. Raich, that the federal government can arrest patients who use marijuana with their doctor’s recommendation even if it is legal under state law. On June 29, 2005, the US House of Representatives defeated the Hinchey Amendment, 161-264, which would have prohibited the use of federal funds for the prosecution of medical marijuana users in states that have passed laws allowing medical marijuana programs.
Currently, the only process that could result in marijuana becoming legal as a medicine under federal law is for privately-funded sponsors to conduct scientific research with the aim of obtaining FDA approval for its use as a prescription medicine. Unfortunately, NIDA’s monopoly on the supply of legal marijuana is a fundamental obstruction to privately-funded research, none of which is currently taking place despite strong 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 research by refusing to allow the University of Massachusetts Amherst to manufacture marijuana for medical research.
NIDA’s monopoly is against the public interest and may be contrary to federal law, which clearly requires adequate competition in the manufacture of Schedule I and II substances for research purposes. [See 21 U.S.C. § 823(a)(1); see also 21 C.F.R. § 1301.33(b).] Researchers have unobstructed access to other Schedule I and II drugs and marijuana should be no exception. Professor Craker is suing the DEA in a DEA Administrative Law Judge hearing, but the DEA can approve the project at any time.
MONOPOLY PROBLEMS: NIDA’s monopoly results in arbitrary and lengthy delays or refusals in providing research material. Chemic Labs, a DEA-licensed analytical lab, was made to wait over two years for a reply to its request to purchase 10 grams for research into vaporizers, a non-smoking delivery system which the Institute of Medicine report recommended be developed. On July 27, 2005, NIDA refused to sell Chemic Labs the 10 grams, preventing the study from taking place. NIDA has also refused to provide marijuana to two FDA-approved protocols (Dr. Abrams, UC San Francisco, marijuana for AIDS wasting syndrome-IND #43-542; Dr. Russo, U. Montana, marijuana for migraines –IND #58,177). NIDA’s monopoly prevents sponsors from conducting research with the strain of marijuana they believe has the most potential. Furthermore, NIDA can legally provide marijuana for research but is not authorized to provide it for prescription use, should FDA approve such use. As a result, the strain of marijuana NIDA provides for research might not even be available for prescription use, an unacceptable uncertainty to sponsors.
RECOMMENDATION: The FDA cannot consider approving marijuana for medical use until the federal government’s unique monopoly on the production of marijuana for medical research is broken. Members of Congress should sign onto a letter to DEA Administrator Karen Tandy urging the DEA to approve Professor Craker’s application in order to facilitate medical marijuana research.