The federal government is taking steps to improve access to legal marijuana for medical and scientific researchers, with the Justice Department announcing that it will take action on long-delayed applications to expand the number of entities certified to grow marijuana plants.
In the three years since DEA first said it would be accepting applications for cannabis manufacturers, the agency has received 33 submissions. In a notice of applications set to be published in the Federal Register on Tuesday, DEA said the “unprecedented” volume of inquiries makes it necessary to develop new regulations before approving pending applications.
The DEA said it would roll out new guidelines that would allow more growers to produce marijuana for scientific and medical research.
That could eventually lead to “safe and effective drug products that may be approved for marketing by the Food and Drug Administration,” the agency said in a regulatory filing.
Attorney General William Barr welcomed the move, saying he is “pleased that DEA is moving forward with its review of applications for those who seek to grow marijuana legally to support research.”
Currently all marijuana used for federally approved researchers must be supplied by the University of Mississippi, as part of a contract with the National Institute on Drug Abuse.
For about five decades, the only authorized supplier of legal weed to labs has been a cannabis garden at the University of Mississippi overseen by the National Institute on Drug Abuse (NIDA).
The Phoenix-based Scottsdale Research Institute (SRI), which researches medical uses of cannabis, filed suit in June, asking the D.C. Circuit Court of Appeals to order the DEA and attorney general to process its application. The agency had a deadline of Wednesday to respond to the lawsuit.
Dr. Sue Sisley, SRI’s principal investigator, said “poor-quality” marijuana was getting in the way of future research. She completed the first randomized trial of “whole plant” marijuana to treat post traumatic stress disorder earlier this year, using marijuana obtained from the University of Mississippi. The cannabis she used for the second phase of the study, the results of which have not yet been published, arrived in powder form. Some samples contained mold, and others were diluted with stems and leaves. She said the quality of the samples was a far cry from the marijuana available for sale in states where it’s already legal for recreational use under state law.
“We have a situation where there [are] thousands of different phenotypes of cannabis being sold throughout the regulated market, the illicit market, and that’s the material that we would like to work with,” Sisley said in an interview earlier this month. “Scientists want to understand or be able to replicate what patients are using in the real world because patients are claiming to have these transformative experiences with cannabis.”
Researchers complained that the monopoly made it hard to get supplies in a timely manner, and the DEA promised in August 2016 that it would expand the program to more growers.
But when the DEA didn’t review or acknowledge the 33 growers who applied to participate, researchers sued.
“The curtailment of the NIDA monopoly would almost certainly increase the supply of the drug to the research community and make researchers less dependent on Ole Miss for their product,” John Hudak, senior fellow of governance studies at the Brookings Institute, said in 2016.
Though there are zero deaths linked to a marijuana overdose, the DEA classifies the plant under the Schedule 1 category of dangerous drugs, the most aggressively banned category, which also includes heroin.
The DEA has yet to take action on the 33 applications it has received since then, as the Trump administration has threatened a crackdown on a drug that is now legal for recreational or medical use in 33 states and the District of Columbia.
Marijuana remains illegal under federal law, creating legal uncertainty and freezing many businesses out of the banking system.
Then-U.S. Attorney General Jeff Sessions told federal prosecutors in January 2018 that they could go after marijuana users and producers in states that had legalized the drug, reversing the hands-off position taken by the Obama administration.
The threat of prosecution has not slowed action at the state level, as eight states have approved marijuana for medical or recreational use since then.
The legal market is expected to reach $12.4 billion in the United States this year and nearly double in size by 2025, according to New Frontier Data.
The DEA says 542 people are now registered to conduct research on the drug, up 40 percent from January 2017, and the production quota has more than doubled over that period.
A wider variety of growers will give those researchers more opportunity, DEA Acting Administrator Uttam Dhillon said.
“We believe registering more growers will result in researchers having access to a wider variety for study,” Dhillon said in a statement.
In addition to moving forward on marijuana grower applications, DEA also clarified that hemp manufacturers “no longer require DEA registration for that purpose” since the crop was federally legalized under the 2018 Farm Bill and so “these applicants may respond in writing with a request to withdraw their applications.”
“Upon receipt of a request to withdraw an application that is received no later than November 1, 2019, DEA will refund all related application fees paid by the applicant,” DEA wrote. “In addition, any listed applicants who no longer wish to obtain registration for any other reason may also request to withdraw their application in writing, and DEA will refund all related application fees paid by the applicant, provided the withdrawal is received no later than November 1, 2019.”