The U.S. Court of Appeals for the District of Columbia Circuit has ordered the Drug Enforcement Administration (DEA) to explain why it has yet to respond to nearly two dozen researchers around the U.S. who applied three years ago for a DEA license to grow research cannabis.
"Hopefully, DEA will finally explain, in a court-filing available for public inspection, the answer to this question that has frustrated everyone," announced Sue Sisley, a physician and researcher at the Scottsdale Research Institute, a Phoenix-based clinical trial company that applied in 2016 for a DEA manufacturing license in order to grow its own cannabis for an ongoing study of medical marijuana as a treatment for veterans suffering from PTSD.
The Scottsdale Research Institute (SRI) sued the Justice Department and the DEA in June. It sought a "writ of mandamus" that would compel the DEA to respond to applicants seeking a license. SRI argued that the Improving Regulatory Transparency for New Medical Therapies Act, signed by President Obama in November 2015, requires "that the Attorney General, upon receiving an application to manufacture a Schedule I substance for use only in a clinical trial, publish a notice of application not later than 90 days after accepting the application for filing." SRI and more than 20 other potential cannabis manufacturers applied for licenses from the DEA in 2016, but a notice of their applications has yet to appear in the Federal Register.
"Thus," RSI's suit argued, "agency action has been unlawfully withheld. And in view of an express directive to prioritize applications relating to clinical research, agency action has most certainly been unreasonably delayed."
Despite congressional appeals to the DEA to complete the application review process, the applicants I've spoken to say they've received no substantive updates from the agency in over a year, and no applicant I spoke with has been contacted by their local DEA field office to schedule an inspection of their facilities, a crucial early step in the review process.
Sisley's lawsuit and the court's order are particularly newsworthy due to the lack of domestically grown cannabis suitable for research with human subjects. The University of Mississippi has the only DEA license for cannabis manufacturing in the U.S. and operates a 12-acre outdoor growing facility under a contract with the National Institutes for Drug Abuse, which is housed within the Department of Health and Human Services. Despite DEA claims to the contrary, researchers say that Mississippi's cannabis is inadequate for testing in human subjects.
The Mississippi cannabis made available to Sisley and her team "arrived in powdered form, tainted with extraneous material like sticks and seeds, and many samples were moldy," SRI's lawsuit claimed. "Whatever reasons the government may have for sanctioning this cannabis and no other, considerations of quality are not among them. It is not suited for any clinical trials, let alone the ones SRI is doing." What's more, federal regulations prohibit the use of Mississippi's cannabis in phase III clinical trials and thus make it practically impossible to develop pharmaceutical products using domestically grown cannabis.
Since August 11, 2016, when the DEA published an announcement in the Federal Register inviting applications for bulk cannabis manufacturers, Republican and Democratic members of both the House of Representatives and the Senate have sent multiple queries to the Justice Department requesting an update on the status of some two dozen applications.
In several appearances before Congress, then-Attorney General Jeff Sessions insisted that the Justice Department was limited by the United Nations Single Convention on Narcotic Drugs. However, many researchers in the U.S. legally import research cannabis from fellow convention signatories Israel and Canada, and the Food and Drug Administration last year approved Epidiolex, a drug developed using cannabis grown in the United Kingdom, another signatory of the narcotics treaty. In addition, the DEA regularly approves applications for the domestic manufacturing of other schedule I drugs, including synthetic cannabis.
The D.C. Circuit has instructed the DEA to respond to SRI's suit by August 28, 2019. The lawsuit is available here.
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