Medical Marijuana

Federal Court Demands Answers From DEA on Stonewalled Research Cannabis Applications

After nearly three years of ghosting research cannabis applicants, the DEA has 30 days to explain its inaction.

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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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  1. Since when have the federal courts have authority over our imperial administrative masters?
    This violates the clear constitutional immunity of bureaucrats everywhere!
    To the barricades!

  2. How many divisions does the court have?

  3. Does anyone seriously believe there’ll be phase 3 clinical trials of cannabis ever, when it’s obvious it’ll be available legally as a non-drug (i.e. for recreational use) within a few years in almost every state? Whose while would it be worth for anyone to invest in to market as a prescription drug?

  4. The very act that created the DEA defines pot as a Schedule One substance – highly abusable and of no medical value. Why would the DEA feel the need to achknowledge and requests for research. The problem isnt the DEA, its the Drug Laws. Repeal/ammend those and this problem fixes itself.

    1. The DEA was commissioned in 1973 by Dick Nixon’s executive order.

  5. Just as I suspected: the government-sanctioned pot grow at University of Mississippi produces only dirt weed unsuitable for human consumption. This warms the cockles of my free market-loving heart.

    1. You don’t know what you are talking about. The DEA says its good, therefore it is good.

      QED

    2. Reason’s had several pretty good articles on this in the past.

  6. Hmmmm.. it would appear that the Good Ol’ Boyz Club that be the DEA are exercising their administrative clout to keep this research lady and her pals out of the Club.

    I suspect that the DEA lot are only too congisant of the niggly fact that if they allow research on a Sched One drug for medical uses, and any are found, that sobstance MUST, by definition, be removed from its classification as Sched One, as it will now have proven medical use, the lack of which is one of only two qualifiers for its Schedule One status. And THAT means that most of the DEA dweebs will no longer be able to suck at the public teat because DEA cannot continue the charade once it is proven cannabis has at least SOME clinically proven medical usefulness.

    They fear the sunlight will fall into the dark corners that are infested with cockroaches of both two and four legged kinds. Once the scurrying is over, the lie will have been exposed for what it is. THEN the REAL fun begins….. with watching the current agents in their frenzy to find REAL work….. work that actually produces somthing beneficial.

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