Huge news: Scottsdale Research Institute, a client Matt Zorn and I have been representing for going on two years now, was one of several companies to hear from DEA last Friday that its application to grow cannabis for research has been preliminarily approved!
As regular readers will know, Matt and I have been working hard on behalf of SRI and its principal, Dr. Sue Sisley, challenging DEA and DOJ's refusal to permit Dr. Sisley to conduct clinical research with dispensary-quality cannabis to determine its potential to help veterans suffering from treatment-resistant PTSD. Indeed, our work continues on other fronts even today as we're currently preparing for a June 10th oral argument in the Ninth Circuit in our case challenging DEA's unlawful five-part test for assessing whether a substance has a "currently accepted medical use in treatment in the United States" for purposes of 21 U.S.C. 812(b)(1)(B) and thus cannot be classified as a schedule I controlled substance.
But DEA's decision last week to license SRI to grow cannabis for research, pending SRI and DEA ironing out the details on a memorandum of agreement to govern SRI's cultivation processes under the license, is a momentous victory for SRI, Dr. Sisley, and veterans. It is also a momentous victory for Matt and me as it marks the culmination of two-years of work in courts across the country challenging DEA/DOJ's unexplained unexplained determination to keep Dr. Sisley out of the lab. So I hope you won't mind if I take a moment to explain why I'm so proud of the work Matt and I did for SRI and Dr. Sisley and why working on these cases has meant so much to me personally.
I'll start with the backstory, including an overview of the litigation. If you want all the details, check out this chronology that contains a ton of information, including references to primary sources. After explaining how we got here, I'll go over why I think my and Matt's work on behalf of SRI and Dr. Sisley is so important, and why I'm so grateful to have had the opportunity to be a part of all this over the past two years.
The Back Story
I'm not going to tell this story in chronological order. Instead, I'm going to start mid-way through, on April 29, 2020. That was the day DOJ's Office of Legal Counsel released, in unredacted form, a copy of its previously undisclosed June 6, 2018 memorandum on “Licensing Marijuana Cultivation in Compliance with the Single Convention on Narcotic Drugs” as part of a settlement in one of the cases Matt and I brought on behalf of SRI and Dr. Sisley: Scottsdale Research Institute v. Department of Justice, No. 20-cv-605 (D. Ariz.). The settlement agreement, which we entered into almost exactly two weeks after filing suit, is available here if you're interested.
The 25-page OLC opinion detailed exactly how and why DOJ concluded back in June 2018 that “DEA must change its current practices and the policy it announced in 2016 to comply with the Single Convention.” In more than ten letters and ten letters and during numerous congressional hearings between 2018 and 2020, members of Congress had repeatedly asked DOJ and the DEA:
- “What is the current status of the twenty-six marijuana manufacturer applications?”
- “What steps have both DEA and DOJ taken to review the twenty-six marijuana
manufacturer applications currently pending?”
- “Please share DOJ’s analysis of the Single Convention and if the opinion of the Justice Department is the same or similar to that of DEA’s.”
- “If there are legal barriers to licensing multiple schedule I marijuana manufacturers under the Single Convention, please identify them.”
The June 2018 OLC opinion, which remained secret from Congress and the American public until our lawsuit on behalf of SRI Dr. Sisley, answered these important questions. Here are the highlights:
In August 2016, DEA announced it would approve new cultivators of marijuana for
research. But soon after, DOJ blocked DEA from proceeding. DOJ then embarked on a “policy review process” culminating in the June 2018 OLC opinion. The opinion concludes that that DEA had to change its current practices and the policy it announced in 2016 to comply with the Single Convention on Narcotic Drugs of 1961--an international treaty to which the U.S. is a signatory. But rather than deny any of the applications—which would have required the agency to state its reasons for the denial, thus subjecting those reasons to public scrutiny and judicial
review—the pending applications remained in administrative purgatory. For years.
Sensing a deep irregularity in the administrative process, SRI filed a mandamus petition in the D.C. Circuit in June 2019, requesting judicial intervention. We hoped DEA would explain to the court what it had not explained to Congress.
Instead, two days before the August 28, 2019 response deadline, DEA processed the pending applications but stated it needed even more time before it could make decisions to promulgate new rules. Two days later, in its court filing, DEA did not defend or explain its delay, but only argued the action was moot.
DEA released the final rule at long last in December 2020, and as already mentioned, notified SRI last Friday that its long-pending application to grow cannabis for research has been preliminarily approved. Since 1968, the federal government has required all researchers to use cannabis grown at the University of Mississippi under a contract with the National Institute on Drug Abuse. This low-quality cannabis has made it impossible for researchers like Dr. Sisley to assess the medical potential of the higher-quality cannabis sold at state-legal dispensaries and used by millions nationwide. Approval of SRI’s registration and others' will end the government monopoly and allow scientists to begin conducting robust clinical trials with real-world cannabis.
Why This Is Such a Big Deal
The notorious NIDA monopoly is finally over: For the first time in more than five decades, the federal government has has opened the door to federally sanctioned research into dispensary-quality cannabis. Put simply, antiquated ideology will stymie modern medical science no more.
As a result, researchers like Dr. Sisley will finally have a realistic chance of taking dispensary-quality cannabis to market as a legal prescription medicine after completing FDA Phase III clinical trials. That was literally impossible with NIDA cannabis because the federal government has always insisted that NIDA cannabis may be used only for academic research, meaning it would be impossible to make it into a prescription medicine even if it could (somehow) successfully complete Phase III clinical trials.
Why I'm so Proud of Dr. Sisley and Our Litigation Efforts on Her Behalf
Dr. Sisley is the one doctor in this country who, for the sake of her veteran- and law-enforcement patients, picked up DEA’s gauntlet and threw her entire life behind unearthing the scientific truth about marijuana’s medicinal potential only to find herself ensnared in a Catch-22 of the government's making. For over ten years, she did everything by the book only to find her application to grow cannabis for research languish in agency purgatory for years.
Turning the tide required litigation. The first lawsuit we filed on her behalf prompted the agency to start processing these applications in the first place. And our second lawsuit forced DOJ to reveal the secret 2018 OLC opinion disclosing the real reason for the delay--that DEA's regulations violated the Single Convention.
Make no mistake, without Dr. Sisley's tireless efforts and the lawsuits we brought on her behalf, no one would be holding a draft memorandum of agreement from DEA/DOJ right now. Without Dr. Sisley, Congress and the American public would still be completely in the dark about the reason for DEA's delay. Without Dr. Sisley, the 2018 OLC opinion would still be secret. Without Dr. Sisley, DEA's regulations would still violate the Single Convention, and the NIDA monopoly would still stand as a senseless obstacle to the scientific research so urgently needed by veterans, children, and the whole host of suffering millions nationwide.
It has been one of the highest honors of my legal career to represent Dr. Sisley in these lawsuits. Not every lawyer can say that they found a way to use FOIA's oft-overlooked reading-room provision to get DOJ to release a secret OLC Opinion. It's not every day that a mandamus petition gets the federal government to take action when years of pressure from legislators on both sides of the aisle could not. We dug deep on these cases because we knew this just had to change.
As you can probably tell, Dr. Sisley is a personal hero of mine at this point, and that's what these cases have become for me--personal. I don't know how the media will portray all this, but as far as I'm concerned, the story of the end of the NIDA monopoly is her story. And I'm infinitely grateful to have had the opportunity to play a small part in it.