On Thursday, the DEA announced a policy change expanding the number of DEA-registered marijuana manufacturers producing marijuana for research. This move is expected to expand and diversify the supply of marijuana for research use. Under the current policy, the only authorized marijuana manufacturer is the University of Mississippi, which operates under a contract with the National Institute on Drug Abuse (NIDA). The process for getting access to University of Mississippi marijuana for research through NIDA has been criticized as overly restrictive and slow. Under the new policy, additional entities may apply to register with DEA; once registered, they would be able to grow and distribute marijuana for FDA-authorized research purposes.
The DEA also released responses to two pending petitions asking the agency to reschedule marijuana. The petitions had been filed by Bryan Krumm in 2009 and by former Washington Governor Christie Gregoire and former Rhode Island Governor Lincoln Chafee in 2011. In a letter responding to the petitions, DEA Acting Administrator Chuck Rosenberg explained that Schedule I includes some substances that are exceptionally dangerous and some that are less dangerous. Rather than being a reflection of relative danger, Schedule I classification is used in the substance has no currently accepted medical use in treatment in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse. According to Rosenberg, marijuana currently meets that criteria.
Despite the decision not to reschedule marijuana, DEA clearly expressed support for marijuana research, performed in compliance with the existing rules. Rosenberg stated that DEA has never denied an application from a researcher to use lawfully produced marijuana in a study determined by the Department of Health and Human Services (HHS) to be scientifically meritorious. During the last two plus years, the total number of individuals and institutions registered with DEA to research marijuana, marijuana extracts, derivatives, and tetrahydrocannabinols (THC) has more than doubled, from 161 in April 2014 to 354 at present. According to Rosenberg, NIDA is filling requests for research marijuana in an average of 25 days. If, based on this research, “the scientific understanding about marijuana changes – and it could change – then the decision [on scheduling] could change,” Rosenberg said.
In December 2015, DEA waived certain regulatory requirements for researchers conducting FDA-authorized clinical trials on cannabidiol (CBD), a constituent part of marijuana that has shown promise in treating a variety of ailments, including seizure disorders. Earlier, in June 2015, HHS eliminated a controversial requirement for Public Health Service review of non-federally funded research protocols involving marijuana.
To further ease the process for researchers, DEA is building an online application system to apply for Schedule 1 research registrations, including for marijuana. It also is drafting guidance to assist Schedule I researchers in that application process. We will continue to monitor the actions of DEA, FDA, and the states with regard to research requirements, pending clinical trials, and steps toward legalization.