Drug & Device News

Professor Lyle Craker of the University of Massachusetts-Amherst Department of Plant, Soil and Insect Sciences has appealed a Drug Enforcement Administration (DEA) decision denying his bid to grow marijuana for medical research. Currently, the only facility in the United States legally authorized to grow marijuana for such purposes is located at the University of Mississippi. The U.S. Court of Appeals for the First Circuit heard oral arguments in May. The case, Craker v. DEA, began with Craker's written request to the DEA for a license to grow marijuana because “[a] second source of plant material is needed to facilitate privately funded, FDA-approved research into medical uses of marijuana, ensuring a choice of sources and an adequate supply of quality, research-grade marijuana for medicinal applications.” In its 2009 denial order, DEA administrator Michele Leonhart wrote that Craker's proposed registration was inconsistent with the United States' obligations under the U.N. Single Convention on Narcotic Drugs, because that convention requires a monopoly on the wholesale distribution of research-grade marijuana in the United States. Leonhart's order also explained that Craker had failed to make a showing that the supply of medical-grade marijuana from the University of Mississippi was inadequate for U.S. research purposes.

Market Exclusivity Remains Elusive for Makena