The Medical Marijuana Catch-22: How the Federal Monopoly on Marijuana Research Unfairly Handicaps the Rescheduling Movement.

I. INTRODUCTIONAs of April 2015, twenty-three states and the District of Columbia permit the therapeutic use of marijuana1 to treat various illnesses or conditions,2 with legalization statutes currently pending in eight other states.3 Despite the growing number of states that allow for the prescription and use of medicinal marijuana, the federal government still classifies the drug as a Schedule I controlled substance,4 the strictest classification of controlled substances and the only type healthcare providers may not legally prescribe.5 As states continue to deliberate the merits of allowing access to marijuana for therapeutic use, it is useful to examine the structural and political forces that have prevented a similar movement at the federal level. This Note does so, and argues that proactive changes-either legislative or administrative-are necessary to remove the handicap that the current regulatory system places on attempts to change federal marijuana policy.Two recent federal appeals court decisions have together created an obstacle for the federal rescheduling movement-one by establishing a high standard for reclassification of a controlled substance,6 and the other by perpetuating an administrative impediment to meeting that standard.7 Americans for Safe Access v. DEA arose after a patient advocacy group petitioned the Drug Enforcement Administration (DEA) arguing that the DEA should reclassify marijuana from Schedule I to Schedule III, IV, or V under the Controlled Substances Act (CSA). The group argued that the reclassification was appropriate because of marijuana's accepted medical use in the United States.8 The D.C. Circuit ultimately upheld a DEA order denying the petition on the grounds that marijuana has no accepted medical use. The court agreed with the DEA's view that formal clinical trials, such as those the Food and Drug Administration (FDA) requires for prescription drugs, are necessary to prove that a controlled substance has an accepted medical use.9The DEA standard requiring formal clinical trials that the court upheld in Americans for Safe Access effectively precludes rescheduling reform because of existing barriers to conducting marijuana research. The barriers exist at two levels: procuring research-grade marijuana and obtaining approval for studies on marijuana's potential therapeutic benefits. To conduct research on marijuana, researchers must register with the DEA and request marijuana from the National Institute on Drug Abuse (NIDA). NIDA-a federal research institute-controls the supply of researchgrade marijuana from the only federally registered marijuana manufacturer in the country, and conducts its own research on the harmful effects of marijuana and other drugs.10 There is evidence, however, that NIDA refuses to supply marijuana to research studies with otherwise adequate credentials, even studies with FDA approval.11 NIDA itself has stated that it is generally not in the business of funding or supporting research into the therapeutic benefits of marijuana or other drugs, thus revealing its own bias against medical marijuana research.12 Together, the DEA's requirement of formal research studies to show accepted medical use and the inaccessibility of research-grade marijuana have created a regulatory catch-22: researchers attempting to show a medical use are unable to conduct the necessary studies given NIDA's monopoly.At least one attempt has been made to establish a federally registered private manufacturer to supply marijuana for research studies.13 Dr. Lyle Craker, a Plant, Soil, and Insect Sciences professor at the University of Massachusetts petitioned the DEA in 2001 with support from the Multidisciplinary Association for Psychedelic Studies (MAPS). Dr. Craker wanted to be registered as a private manufacturer of marijuana for clinical research14 pursuant to the CSA requirements for manufacturers of controlled substances in Schedule I or II.15 In Craker v. DEA, the First Circuit upheld the DEA's denial of Craker's petition, granting Chevron deference to the DEA Administrator's decision and holding that Craker "failed to demonstrate that the current supply of marijuana was not adequate and uninterrupted," as required by the CSA. …