DEA Denial of Petition to Reschedule Marijuana

Pharmacy TimesOctober 2014 Diabetes
Volume 80
Issue 10

Issue of the Case

When the Drug Enforcement Administration (DEA) denied a petition to have marijuana shifted from Schedule I to a lower level of control based on a determination by the US Department of Health and Human Services (HHS) that marijuana lacks a currently accepted medical use in the United States, did the DEA’s decision constitute arbitrary and capricious action?

Facts of the Case

In 2002, the Coalition to Reschedule Cannabis filed a petition with the DEA to have marijuana reclassified from Schedule I to Schedule III, IV, or V. One of the bases for this filing was the petitioners’ position that placement in Schedule I was inappropriate because the plant “has an accepted medical use in the United States.” To support their position, they cited a variety of “alleged peer-reviewed published studies” on potential medical applications of the product. As required by statute, the DEA passed the petition to the HHS for assessment of the science undergirding the petition.

HHS officials reported back that marijuana lacks a currently accepted medical use in the United States. That conclusion was based on the DEA’s 5-pronged test requiring the following: known and reproducible drug chemistry; adequate safety studies; adequate and well-controlled studies demonstrating efficacy; acceptance of the drug by qualified experts; and widely available scientific evidence.

HHS concluded that the chemistry of marijuana was not “known and reproducible” because there had not been a complete scientific analysis of the 483 known components of the cannabis plant. Also, despite ongoing research projects, there were no studies of sufficient quality to assess “the efficacy and full safety profile of marijuana for any medical condition.” Next, there was a “material conflict of opinion among experts” regarding medical safety and efficacy, meaning that there could be no finding that there was acceptance of the drug by qualified experts. Finally, the raw research data that could constitute “scientific evidence” typically were not available in a format that would facilitate “adequate scientific scrutiny of whether safety and efficacy could be established.”

This HHS report was received by the DEA in 2006. Officials at the DEA reviewed the information and assessments it had requested, leading to a decision in 2011 to deny the request for rescheduling. The stated basis for this decision was the DEA’s conclusion that “The limited existing clinical evidence is not adequate to warrant rescheduling of marijuana under the Controlled Substances Act.”

Fourteen days after the DEA announced this decision, a case was filed by an organization known as Americans for Safe Access, along with the Coalition to Reschedule Cannabis and several others. The petition to the US Court of Appeals argued that the DEA had engaged in arbitrary and capricious action when it concluded that marijuana lacks a currently accepted medical use and that the agent has a high potential for abuse. It was requested that the matter be sent back to the DEA so the decision could be reconsidered.

The Court’s Ruling

The petition filed by the advocacy organizations and others seeking referral of the matter back to the DEA for reconsideration was denied.

The Court’s Reasoning

At the outset, the court clarified that the issue before it was not whether marijuana could have some medical benefits. Actually, the issue to be addressed was whether the DEA’s decision to decline to initiate proceedings to reschedule marijuana was arbitrary and capricious. Pointing to an earlier decision by the US Supreme Court, the Court of Appeals emphasized that “the scope of review under the ‘arbitrary and capricious’ standard is narrow, and a court is not to substitute its judgment for that of the agency.”

The Court of Appeals noted that reclassification of the agent from Schedule I to Schedule III, IV, or V requires a “currently accepted medical use.” The court deferred to the DEA’s interpretation of the relevant regulations. It also emphasized that substantial evidence supported the DEA’s determination that such studies did not exist.

The court also noted that under the relevant provision in the federal Controlled Substances Act, the findings and recommendations of the HHS were binding on the DEA because the scientific and medical determinations were to be made by the HHS, not by the DEA.

This case places additional focus on the differences between federal law and provisions in the laws of the numerous states that have taken steps to “decriminalize” marijuana. The US Department of Justice has communicated to various US attorneys around the country that there are more pressing issues in federal law enforcement that take priority over prosecuting those who use marijuana under state statutory frameworks. This does not mean that the federal government has decriminalized or reclassified marijuana; it is merely a reflection of prosecutorial discretion.

Dr. Fink is professor of pharmacy law and policy and Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy, Lexington.

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