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By: Judith Cassel
There is a natural tension between cannabis and research. In order to legalize marijuana, it must be removed from Schedule 1 of the Controlled Substance Act (CSA). To remove marijuana from Schedule 1, more evidence must be gathered through research that cannabis is an effective medicine to treat certain medical conditions. But, because marijuana is on the Schedule 1 of the CSA, it is federally illegal, and hence, excruciatingly difficult to get approval for cannabis research… until recently.
Historically, research on the effects of marijuana use was possible (using the word “possible” in its most generous sense); however, the contortions a researcher would need to go through in order to obtain said approval were clearly prohibitive. Assuming a researcher successfully navigated the bureaucracy and gained approval to perform cannabis research, there was only a single source from which that researcher could obtain marijuana – the University of Mississippi.
The University of Mississippi became the sole provider of cannabis for research as a result of the DEA’s interpretation of a 1961 treaty, the “Single Convention on Narcotic Drugs.” Under the old interpretation of this treaty, any legalized grower had to actually be the United States and by limiting all grows to one entity with whom the U.S. contracted, allowed for the interpretation to be that the U.S. was the grower. The University of Mississippi had a contract with the National Institute on Drug Abuse (NIDA), and therefore the University of Mississippi was considered an extension of NIDA which was in turn an extension of the U.S. government.
However, during the last 18 months, the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA) (under the Department of Justice), and the National Institutes of Health (NIH) have determined that: (1) expanded research is needed into the usefulness of medical marijuana and its derivatives; and (2) increased supplies of marijuana need to be made available to researchers.[1] In short, the supply coming out of the University of Mississippi, could not adequately meet FDA, NIH, and DEA’s new-found philosophy. Despite the new philosophy and DEA, FDA, and NIH’s willingness to entertain growers outside of the University of Mississippi, the process can still be arduous and precise.
Where does a research institution start when looking to perform marijuana research and/or to grow marijuana for research purposes? It is important to seek adequate legal counsel because a misstep in the application process can destroy the researcher’s ability to ever be approved.[2] A research institution must apply to be registered with the FDA. A grower who seeks to become a supplier for a research institution must also apply to the DEA using Form 225 and pursuant to the requirements of 21 U.S.C. 822(a)(1) and 823(a). An applicant seeking to be a grower for a research institution must prove the research is consistent with: (1) the public interest, and (2) the 1961 Single Convention on Narcotic Drugs Treaty. DEA in consultation with NIH and the FDA, will review each application to determine, among other things, whether the proposed supply of cannabis is “necessary to provide an adequate and uninterrupted supply of marijuana (including extracts and other derivatives) to researchers in the United States.”[3]
The good news for anxious researchers and patients is that the DEA, FDA and the NIH are now willing to approve private growers to supply research provided approved growers work with DEA on distribution to insure prevention of diversion. Approval can even be obtained if the grower also sells to the private sector, so long as the private sector is seeking drug product development. If a grower is approved, the grower will enter into a written memorandum with DEA to supply DEA-registered researchers whose protocols have been approved by the Department of Health and Human Services (HHS).
As a side note, research has already produced two federally legalized synthetic forms of chemicals found in marijuana — Marinol and Syndros. Both are used for treatment of nausea in cancer patients and weight gain in patients with AIDS.
While there continues to be tension between the illegality of medical marijuana on the federal level and the research necessary for legalization, the expansion of available cannabis for research is a step in the right direction.
[1] Drug Enforcement Administration Policy Statement, August 12, 2016.
[2] 21 C.F.R. 1301.15.
[3] 74 FR at 2127-2130.
