American Journal of Law & Medicine

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

I.  INTRODUCTION II. RESCHEDULING MARIJUANA AND AMERICANS FOR SAFE ACCESS     A. The Controlled Substances Act and Requirements for Rescheduling     B. Early rescheduling cases     C. Americans for Safe Access v. DEA III. RESEARCHING MARIJUANA AND CRAKER     A. Procedure and Requirements for Becoming a Private Manufacturer     of Marijuana     B. Procedure and Requirements for Obtaining Marijuana for Research     C. Craker's Petition     D. Decision of the Administrative Law Judge     E. Decision of the DEA Administrator     F. Decision of the Court of Appeals IV. RESULTING OBSTRUCTION TO RESEARCH AND POSSIBLE SOLUTIONS     A. The Catch-22 at the Intersection of Americans for Safe Access     and Craker     B. Possible Solutions     C. Potential Improvements on the Horizon V. CONCLUSION 

I. INTRODUCTION

As of April 2015, twenty-three states and the District of Columbia permit the therapeutic use of marijuana (1) 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 1 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. (9)

The 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 research-grade 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 research (14) 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. (16)

Together, Americans for Safe Access and Craker effectively leave control of the rescheduling of marijuana in the hands of NIDA. The prohibition against the private manufacturing of research marijuana allows NIDA to maintain its monopoly over the supply of marijuana. Therefore, NIDA can continue to deny marijuana for qualified research studies, preventing anyone from conducting the research necessary to show the accepted medical use required to reschedule marijuana. This Note outlines this problem and provides an argument in favor of allowing greater access to research-grade marijuana to give researchers the opportunity to show a medical use sufficient to meet the DEA's rescheduling standards.

Part II of this paper analyzes the CSA, focusing on the requirements for rescheduling a controlled substance and the application process and requirements to become a manufacturer or distributor of a controlled substance. Part III discusses the decision in Americans for Safe Access and relevant statutes, regulations, and precedents. Part IV moves to Craker and the current availability of research-grade marijuana. Part V of the paper addresses the catch-22 created by the intersection of these two decisions and offers possible solutions to facilitate a more considered decision on the rescheduling of marijuana.

II. RESCHEDULING MARIJUANA AND AMERICANS FOR SAFE ACCESS

A. THE CONTROLLED SUBSTANCES ACT AND REQUIREMENTS FOR RESCHEDULING

Passed in 1970 as part of the Comprehensive Drug Abuse Prevention and Control Act, the CSA establishes five schedules into which all controlled substances are classified. (17) The CSA authorizes the Attorney General to add to, transfer between, or remove from schedules any substance deemed to meet, or not meet, the inclusion criteria of a schedule. (18) Each schedule requires the Attorney General to make specific findings with respect to a substance's potential for abuse, the existence of a currently accepted medical use, and the danger of dependence when using the substance. (19) For example, to classify a substance in Schedule I, the Attorney General must first find that the substance has a high potential for abuse, that it has no currently accepted medical use, and that there is a lack of accepted safety for its use under medical supervision due to a high likelihood of physical or psychological dependence. Schedule I currently includes, among other substances, heroin, lysergic acid diethylamide (LSD), 3,4-methylenedioxymethamphetamine (MDMA), and marijuana. (20)

The CSA provides that the Attorney General may initiate formal rulemaking procedures to make changes to substance classification on his or her own motion, by request of the Secretary of Health and Human Services (the "Secretary"), or upon petition by an interested party. (21)

DEA rules control these petitions by interested parties. The petitions serve to "initiate proceedings for the issuance, amendment, or repeal of any rule or regulation issuable pursuant to the provisions of [21 U.S.C. [section] 811]." (22) The DEA requires that petitions include "[t]he proposed rule in the form proposed by the petitioner ... [and a] statement of the grounds [upon] which the petitioner relies for the issuance (amendment or repeal) of the rule." (23) Furthermore, in stating the grounds for the rule, the petitioner "shall include a reasonably concise statement of the facts relied upon by the petitioner, including a summary of any relevant medical or scientific evidence known to the petitioner...." (24) The DEA Administrator is not required to initiate proceedings to reschedule a controlled substance upon petition by an interested party. The Administrator may deny a petition if she finds that the petition is lacking any of the regulatory requirements or that "the grounds upon which the petitioner relies are not sufficient to justify the initiation of proceedings." (25)

Before initiating rescheduling proceedings, the Attorney General must "request from the Secretary a scientific and medical evaluation, and his recommendations, as to whether such drug or other substance should be so controlled or removed as a controlled substance." (26) The CSA requires that in issuing the scientific and medical evaluation and recommendations, the Secretary must consider the following factors about the drug or other substance in question:

(1) Its actual or relative potential for abuse.

(2) Scientific evidence of its pharmacological effect, if known.

(3) The state of current scientific knowledge regarding the drug or other substance.

(4) Its history and current pattern of abuse.

(5) The scope, duration, and significance of abuse.

(6) What, if any, risk there is to the public health.

(7) Its psychic or physiological dependence liability.

(8) Whether the substance is an immediate precursor of a substance already controlled under [the CSA]. (27)

The CSA also provides that the scientific and medical evaluations and recommendations of the Secretary are binding on the Attorney General, "and if the Secretary recommends that a drug or other substance not be controlled, the Attorney General shall not control the drug or other substance. …

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