Letter to the Hon. Chuck Rosenberg, Acting Administrator, Drug Enforcement Administration - Take Action on Medical Marijuana

Letter

Dear Acting Administrator Rosenberg,

Currently, more than half of U.S. states have passed laws allowing medical use of the cannabis plant and 42 states allow the medical use of some substance derived from cannabis. Nevertheless, federal policies continue to hinder medical researchers' ability to study the benefits of cannabis, particularly as a therapy for conditions which are resistant to other forms of treatment. As noted in a letter sent to President Obama, dated April 12, 2016, the two greatest administrative barriers impeding scientists are the research restrictions created by the Schedule I classification of cannabis and the artificial limitation of a research supply. Since that letter was sent, additional information has come to light regarding these issues and, based on this information, we ask that you take immediate action to remove these barriers.

Remove Cannabis from Schedule I

Cannabis is currently listed under the Controlled Substances Act (CSA) with a Schedule I designation, reserved only for substances with no "accepted medical use." However, it has been brought to our attention that the Department of Health and Human Services (HHS) has already determined that medication naturally derived from the cannabis plant has a medical use. On June 1, 2010, HHS recommended to the DEA that "FDA-approved drug products containing naturally-derived [from the cannabis plant] dronabinol in sesame oil in a gelatin capsule be rescheduled to Schedule III of the CSA," and that as result of the recommendation, generic drugs that cite the FDA-approved drug Marinol as the reference listed drug will be controlled in Schedule III. The DEA accepted this recommendation and the proposed rule was placed in the federal register in November of 2010. The proposed rulemaking change stated, "Congress structured the CSA so that there would be no distinction--for scheduling purposes--between brand name drug products and their generic equivalents." According to the CSA, any substance placed in Schedule III must have an accepted medical use and conversely, no substance with an accepted medical use may remain in Schedule I. By proposing that natural generic equivalents be rescheduled to Schedule III, the DEA acknowledged that this substance has a medical use, regardless of whether it is synthetically made or natural. Although no explanation has been offered for why this rule was not implemented, it has also been brought to our attention that objections were raised by competitor companies which manufacture synthetic versions of this medication. However, even these objections do not challenge the medical use of this substance, which HHS and DEA had acknowledged. Pursuant to 21 U.S.C. 812(b)(1)(b), and given that both HHS and DEA have acknowledged an accepted medical use for a substance uniquely produced in nature by the plant Cannabis sattiva L., we request that you take immediate action to remove "cannabis" and "tetrahydrocannabinols" from Schedule I.

End the Research Supply Monopoly

To date, the DEA has only issued a single license for the cultivation of cannabis for medical research in the United States, to the University of Mississippi, which is funded through a National Institute on Drug Abuse (NIDA) contract. Previously, the DEA has stated this limitation to a sole license through NIDA was required by the Single Convention on Narcotic Drugs. When presented with evidence that the U.K. is able to fulfill its treaty obligations without this limitation, the DEA has previously stated, "It is for the United States government to interpret its responsibilities under the treaty."

The Department of State, in a response to a request for information from its Bureau of International Narcotics and Law Enforcement regarding the interpretation of the Single Convention on Narcotic Drugs (and specifically, whether Canada, which has issued 32 licenses, is in violation of the treaty) stated, "If a party to the Single Convention issued multiple licenses for the cultivation of cannabis for medical and scientific purposes, that fact alone would not be a sufficient basis to conclude that the party was acting in contravention of the Convention…use of the term "cultivators" suggests that the Convention contemplated more than on cultivator could be licensed…Nothing in the text of the Single Convention, nor in the Commentary, suggests that there is a limitation on the number of licenses that can be issued… Moreover, we are not aware that the International Narcotics Control Board has highlighted the number of licenses as an issue of concern."

As the agency authorized to provide the U.S. government's interpretation of international treaties, the State Department has determined that the Single Convention does not limit the number of licenses the DEA may issue to cultivate cannabis for medical and scientific purposes, and that a system such as that established in Canada, under which the government provides licenses to multiple private companies to cultivate cannabis for medical and scientific uses, is not a violation of a government's responsibilities under the treaty. Therefore, we ask that you clarify this policy immediately, and issue a public statement informing the research community that the DEA, in compliance with international obligations, will accept new applications to bulk manufacture cannabis for medical and scientific purposes, to be approved on merit-based criteria.

In light of this new information, we look forward to your immediate action to remove these two administrative barriers to research. If you are not prepared to take action at this time, we request a personal meeting with you to discuss your reasons for not doing so.