Blunt Talk from the D.C. Circuit: No “Adequate and Well-Controlled Studies Exist” on Marijuana’s Medical Efficacy; Dismisses Appeal of DEA’s Denial of Marijuana Rescheduling Petition

January 27, 2013

By Karla L. Palmer

On January 22, 2013, the United States Court of Appeals for the District of Columbia Circuit dismissed a petition for review filed by several interest groups and individuals who petitioned DEA to initiate the federal rescheduling of marijuana.  The case stems back to a 2002 Citizens Petition filed by the Coalition to Research Cannabis wherein the Coalition and ultimately others requested DEA to initiate proceedings to reschedule marijuana from the most restrictive Schedule I classification (i.e, no accepted medical use) to a Schedule III, IV or V drug.  DEA denied the petition nine years later on July 8, 2011. See Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 76. Fed. Reg. 40,552 (July 8, 2011).  Despite less restrictive marijuana laws in several states pending or since the filing of the petition, DEA specifically found that there is still no “currently accepted medical use for marijuana in the United States,” and that the “limited existing clinical evidence is not adequate to warrant rescheduling of marijuana” under the Controlled Substances Act.

Petitioners claimed on appeal that DEA arbitrarily and capriciously ignored in its rescheduling review numerous peer-reviewed scientific studies that demonstrated that marijuana is indeed effective in treating many different medical conditions.  DEA argued that the appeal should be dismissed because, procedurally, Petitioners lacked standing to bring the appeal and, substantively, DEA’s denial of the petition was based on sound agency reasoning that the Court should not disturb. Concerning the merits of the case, the Court noted that the narrow question before it was not whether marijuana had “some” medical benefit, but simply whether DEA’s decision declining to initiate rescheduling proceedings was arbitrary and capricious.

In reviewing the Agency’s reasons for denying the Citizens Petition, the Court noted that the DEA engaged in the requisite assessment under the Controlled Substances Act (CSA) of each of the five statutory elements necessary to determine whether there is a “currently accepted medical use” for the drug in question:  (1) The drug’s chemistry must be known and reproducible; (2) there must be adequate safety studies; (3) there must be adequate and well-controlled studies proving efficacy; (4) the drug must be accepted by qualified experts; and (5) the scientific evidence must be widely available.  The Court also noted that in reaching a rescheduling decision, DEA must request (and did in fact receive) from the Department of Health and Human Services (“HHS”) a scientific and medical evaluation and a recommendation concerning the appropriate scheduling for the drug, which recommendations are binding on DEA inasmuch as they rest on science and medical determinations.  The Court noted that HHS concluded in its 2006 scientific and medical evaluation that marijuana lacked any currently accepted medical use in the United States.  Thus, DEA found that the limited existing clinical evidence was not adequate to warrant rescheduling.  Reviewing DEA’s decision, the Court only had to consider one of the five statutory elements: “the existence of ‘adequate and well-controlled studies proving efficacy,’ (and there were none) to resolve Petitioner’s claim.”

After what the Court found was an “exhaustive examination,” and despite Petitioner’s claims that it cited more than 200 peer reviewed studies demonstrating marijuana’s efficacy, and disregarding the voluminous peer-reviewed studies, DEA determined there was no evidence of adequate, well-controlled studies demonstrating marijuana’s safety and effectiveness” as a medicine, and there was no consensus among experts on these issues.  In addition, the Court noted that the enactment of state laws permitting use of marijuana for medical purposes did not amount to scientific evidence supporting its medical use.

The Court concluded, at bottom, that the dispute turned on the Agency’s interpretation of its own regulations, which construction the Court determined was “eminently reasonable;” thus the Court was obligated to defer to the Agency’s interpretation of “adequate and well controlled studies.”  The Court found nothing in the record that could “move us to conclude that the Agency failed to prove by substantial evidence that such studies confirming marijuana’s medical efficacy do not exist.”