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January 23, 2013

Petition to reclassify marijuana from Schedule I denied

By Trin Legaspi, JD, LLM

The district court in the District of Columbia upheld the Drug Enforcement Agency's (DEA) denial of a petition to reschedule marijuana from a Schedule I classification based on the DEA's determination that there was limited existing clinical evidence to prove marijuana's safety and efficacy for medical use (Americans for Safe Access v DEA, January 22, 2013, Edwards, H.T.). The court held the DEA's denial of the rescheduling petition survives review and defers to the DEA's interpretation of the regulations that define "currently accepted medical use" to require "adequate and well-controlled studies proving efficacy." The court found there is no substantial evidence that such studies exist. The DEA had previously denied on July 8, 2011, the Americans for Safe Access' petition to reschedule marijuana for medical use to a Schedule III, IV, or V classification.

Analysis. Under the Controlled Substances Act (CSA), Schedule I, is the most restricted drug classification and the production, sale, and use of marijuana is largely banned by federal law. A drug is placed in Schedule I if it has a high potential for abuse and it has no currently accepted medical use in treatment in the United States. The criterion for Schedule III, IV, and V, drugs is the existence of a currently accepted medical use in treatment in the U.S. under 21 U.S.C. sec. 812(b)(3)-(5). Unlike Schedule I drugs, federal law permits individuals to obtain Schedule III, IV, or V drugs for personal medical use with a valid prescription. The DEA based its determination to classify marijuana in Schedule I on HHS' scientific and medical evaluation that marijuana lacks a currently accepted medical use in the U.S.

Denial to reschedule marijuana. The court held the DEA's decision not to reschedule marijuana is supported by substantial evidence. The court stated its decision was based on one factor, the lack of "adequate and well controlled studies proving efficacy." The DEA's decision was based on HHS' scientific and medical evaluation that medical use of marijuana has not progressed to the point that marijuana could be considered to have a "currently accepted medical use." The DEA concluded more research and larger studies are needed to prove marijuana's safety and efficacy, since the current clinical research and reviews are not enough to meet the standard for "medical use." The court held the Americans for Safe Access' reliance on "peer review" studies were not enough to establish "medical use" and they did not convince the court that the DEA or HHS ignored any significant scientific studies to make their determinations. Further, the Institute of Medicine's (IOM) 1999 report that was reviewed by the DEA fairly concluded the IOM called for further research in the therapeutic uses of cannabinoids; however, it did not recognize marijuana's acceptance for medical use, only its potential therapeutic utility.

Standing. The court held one party, Michael Krawitz (Krawitz), had individual standing to challenge the DEA's determination. Krawitz, a veteran of the U.S. Air Force, was harmed by the DEA's classification of marijuana because it deprived him of services he is entitled to receive free of charge from the Veteran's Administration (V.A.). The record indicated the VA asked Krawitz, as a condition of his pain management treatment, to sign a "Contract for Controlled Substance Prescription" that would prohibit him from using medical marijuana. Krawitz contended that because of his refusal to sign that contract he must now seek medical treatment outside the VA system. Krawitz also contended he is financially injured because he must pay a non-VA physician in Oregon so that he can obtain referral forms to participate in Oregon's medical marijuana program.

The court held Krawitz clearly established an injury; as a veteran he is entitled to free medical care from the VA system, which normally includes the completion of forms by healthcare professionals based on an exam or knowledge of the veteran's condition. Krawitz pays $140 out- of-pocket for care he could otherwise receive free from the VA. The court held there was clear evidence to establish the harm Krawitz suffers was "attributable to the classification" since the VA's refusal to complete Krawitz's medical marijuana forms was traceable to the DEA's continued decision to classify marijuana as Schedule I. VHA Directive 2011-004, prohibits VA providers from completing state medical marijuana forms, and it cites three times to marijuana's Schedule I status. The VA's compliance with the CSA is the only justification the VA Directive cited for this policy. Therefore if marijuana were to be rescheduled to reflect its potential for medical use, the VA would have no express reason to retain VHA Directive 2011-004 and VA clinicians would likely be subject to a non-discretionary duty to complete Krawitz's state medical marijuana forms.

Dissenting opinion. Judge Karen Henderson dissented with the majority opinion that Krawitz had standing. She argued the majority should not have allowed supplemental filings in the case because the filings asserted a new theory of standing. The majority recognized her dissent in their opinion.

The case number is 11-1265.

Attorneys: Joseph David Elford (Americans for Safe Access) for Americans for Safe Access, Coalition to Reschedule Cannabis, Patients Out of Time. Lanny A. Breuer (U.S. Department of Justice) for Drug Enforcement Administration.

Companies: Americans for Safe Access; Coalition to Reschedule Cannabis; Patients Out of Time

MainStory: TopStory ControlledNews DistrictofColumbiaNews

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