After much speculation in the midst of historic momentum to legalize marijuana, Drug Enforcement Agency (DEA) Acting Administrator Chuck Rosenberg recently replied to petitions to remove marijuana from its Schedule I status. On August 11, 2016, Rosenberg announced via correspondence to petitioners that – at least for now – marijuana will remain classified as a Schedule I substance under the federal Controlled Substances Act (CSA). However, the correspondence also publically ushered in a new era of a research-oriented approach, and painted the DEA as working with the NIDA, FDA, and HHS to support and promote legitimate research of marijuana and its constituent parts.
First, Rosenberg explained how the DEA’s legal obligations under the CSA are based on the FDA’s drug approval process, and how the various federal agencies work together to form scientifically based decisions. The DEA is legally bound to follow the decisions made by these agencies regarding the scheduling of a substance under the CSA. Rosenberg states the conclusions are based on “a full review of the relevant scientific and medical literature regarding marijuana.” Rosenberg noted that the criteria for each Schedule is set by statute.
Acknowledging that marijuana “is less dangerous than some substances in other schedules,” Rosenberg emphasized that the scheduling hierarchy shouldn’t be thought of in terms of “relative danger.” Instead, the Schedule upon which a substance is placed is based on specific statutory criteria. Rosenberg stated, “[a] substance is placed in Schedule I if it has no current medical use in treatment in the United States …” and is not supported by safe use under medical supervision. Despite recent discoveries about the sometimes miraculous properties of marijuana, these discoveries are currently considered anecdotal, because they are not supported by hard science, nor administered by Medical Doctors. Rosenberg appeared to indicate through this announcement that scientific research will now be broadened and encouraged to legitimize the clinical benefits found from the marijuana plant.
Rosenberg touted a number of ways the DEA and NIDA have made efforts to foster marijuana research at the federal level:
- Citing a doubling of the number of research registrations since 2014, Rosenberg declared the DEA would propose rules to be published in the Federal Register to approve additional marijuana growers to increase the supply for research. Currently, only the University of Mississippi is permitted to grow marijuana for research. Rosenberg indicated both private growers and research institutions could participate.
- Rosenberg also noted that no application from a researcher to study lawfully produced marijuana has been denied, if the HHS deemed the study to be meritorious.
- As further example of the DEA’s softening to research, Rosenberg referenced its December 2015 decision to waive certain regulatory requirements for cannabidiol (CBD) clinical-trials on human subjects, and noted that no request for a waiver under this program has been denied.
- Finally, the DEA announced that it is creating an online application process to expedite research registration, and is developing guidance materials to assist researchers in the online application process.
Rosenberg concluded, “[i]f the scientific understanding about marijuana changes – and it could change – then the decision could change. But we will remain tethered to science, as we must, and as the statute demands.” Rosenberg also promised the DEA “will continue to seek ways to make the process for those researchers more effective.”
All things considered, the decision appears to be a net positive, setting the stage to develop the research which will eventually support lifting the federal ban on marijuana.