June 30, 2016

Senator Gillibrand, Joined By Bipartisan Group Of Senators And Representatives, Urge DEA To Remove Barriers To Research On Medical Marijuana, Request Meeting

Citing New Information from the State Department and Documents from HHS, Senators and Representatives Urge DEA to Remove Cannabis from List of Schedule I Controlled Substances and End Medical Marijuana Research Supply Monopoly Senators Request Meeting with DEA Administrator If He Does Not Take Action On Medical Marijuana

Washington, D.C. – U.S. Senator Kirsten Gillibrand (D-NY), along with Senators Cory A. Booker (D-NJ), Jeffrey A. Merkley (D- OR), Barbara Boxer (D-CA), and U.S. Representatives Earl Blumenauer (D-OR), Dana Rohrabacher (R-CA), Jared Polis (D-CO) and Ted Lieu (D-CA) sent a letter today urging acting Drug Enforcement Administration Administrator Chuck Rosenberg to remove barriers to research on medical marijuana to facilitate new medical research on cannabis and its derivatives. The Senators and Representatives are also requesting a meeting with Administrator Rosenberg if he does not take action on medical marijuana. 

Citing documents showing that the information from the Department of Health and Human Services (HHS) which has already determined that medication naturally derived from the cannabis plant has a medical use, the Senators and Representatives are urging DEA Administrator Rosenberg to remove cannabis from the list of Schedule I controlled substances, reserved only for those substances with no “accepted medical use.

Citing new information from the Department of State indicating that the U.S. is not bound by treaty to restrict the total number of licenses to grow cannabis, the Senators and Representatives also urging DEA Administrator Rosenberg to end the monopoly on the research supply and grant multiple licenses for the cultivation of cannabis for medical research. To date, the DEA has only issued a single license to the University of Mississippi and last year only two researchers in the United States received cannabis for medical research with human patients.

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. Yet, 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. 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.

“We request that you take immediate action to remove ‘cannabis’ and ‘tetrahydrocannabinols’ from Schedule I. We also ask that you 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,” the Senators and Representatives wrote in the letter, citing documents from HHS and new information from the Department of State. “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.”

The full text of the letter is included below:

 

 

The Honorable Chuck Rosenberg

Acting Administrator

Drug Enforcement Administration

8701 Morrisette Drive

Springfield, VA 22152                                                                                  

 

 

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.

 

Sincerely,

 

           

Kirsten Gillibrand                                                       Cory A. Booker                     

United States Senator                                                 United States Senator

 

 

Jeffrey A. Merkley                                                      Barbara Boxer            

United States Senator                                                 United States Senator

 

 

Earl Blumenauer                                                         Dana Rohrabacher     

Member of Congress                                                   Member of Congress

 

 

Jared Polis                                                                   Ted Lieu                                 

Member of Congress                                                   Member of Congress

 

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