Case: 20-71433, 10/06/2020, ID: 11850010, DktEntry: 30, Page 1 of 34
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`No. 20-71433
`_________________________________________
`UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`_________________________________________
`
`SUZANNE SISLEY, M.D.; SCOTTSDALE RESEARCH INSTITUTE, LLC;
`BATTLEFIELD FOUNDATION, DBA FIELD TO HEALED; LORENZO SULLIVAN;
`KENDRICK SPEAGLE; GARY HESS,
`Petitioners,
`
`v.
`U.S. DRUG ENFORCEMENT ADMINISTRATION; WILLIAM BARR, ATTORNEY GENERAL;
`TIMOTHY SHEA, ACTING ADMINISTRATOR, DRUG ENFORCEMENT ADMINISTRATION
`Respondents
`
`PETITION FOR REVIEW FILED BY SUZANNE SISLEY,
`M.D.; SCOTTSDALE RESEARCH INSTITUTE, LLC;
`BATTLEFIELD FOUNDATION D/B/A FIELD TO
`HEALED; LORENZO SULLIVAN; KENDRICK SPEAGLE;
`AND GARY HESS
`BRIEF OF LORI WALKER, PHD, STEPHEN DEFELICE, MD, LYLE E.
`CRAKER, PHD, DANIELA VERGARA, PHD, CHRISTOPHER J.
`HUDALLA, PHD, RACHNA PATEL, MD, WENDY AND TOM TURNER,
`MAUREEN LEEHEY, MD, AND CAMILLE STEWART, MD
`AS AMICUS CURIAE IN SUPPORT OF PETITION FOR REVIEW
`
`Giancarlo Urey
`giancarlourey@dwt.com
`Nicole S. Phillis
`nicolephillis@dwt.com
`Heather F. Canner
`heathercanner@dwt.com
`DAVIS WRIGHT TREMAINE LLP
`865 S. Figueroa Street, Suite 2400
`Los Angeles, California 90017-2566
`Telephone: (213) 633-6800
`Facsimile: (213) 633-6899
`
`John McKay
`johnmckay@dwt.com
`Christopher Morley
`christophermorley@dwt.com
`DAVIS WRIGHT TREMAINE LLP
`920 Fifth Avenue, Suite 3300
`Seattle, Washington 98104-1610
`Telephone: (206) 622-3150
`Facsimile: (206) 622-7700
`Counsel for Amicus Curiae
`Lori Walker, PhD, et al.
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`IDENTITY AND INTEREST OF AMICUS CURIAE
`
`Each of the doctors, scientists and researchers below has experience in the
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`scientific and medical fields, including research on medical marijuana. As
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`reaffirmed below, the views expressed in this brief are their own as individuals
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`only and are not attributed to any affiliated entities, research institutions, or
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`universities.
`
`The amici listed below are likewise familiar with both the research
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`limitations created by the Schedule I classification and the general clinical research
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`landscape. They offer this brief in support of Petitioners’ request to initiate
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`rulemaking hearings regarding the rescheduling of cannabis (i.e., marijuana) under
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`the Controlled Substances Act.
`
`Lori Walker, PhD is a cardiovascular scientist in the Department of
`
`Medicine, Division of Cardiology at the University of Colorado Anschutz Medical
`
`Campus. Dr. Walker has expertise in vascular and cardiac muscle mechanics, the
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`biochemistry of cardiovascular pathologies, and cardiovascular wellness.
`
`Currently, Dr. Walker focuses her research on delineating the cardiovascular
`
`effects of marijuana in healthy adults and in patients with cardiac disease. Dr.
`
`Walker has a history of successful funding through the NIH and other agencies
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`including the American Heart Association, the Colorado Clinical and Translational
`
`Science Institute, the Center for Women’s Health, and the Colorado Department of
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`Public Health and Environment. With over 60 publications, she has a published
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`track record investigating molecular regulation of cardiac and vascular signaling
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`changes with health and disease.
`
`Stephen DeFelice, MD is the founder and chairman of FIM, the Foundation
`
`for Innovation in Medicine, a nonprofit organization established in 1976 whose
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`purpose is to accelerate medical discovery by establishing a more productive
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`clinical research community. A graduate of Temple University, Dr. DeFelice
`
`received his M.D. from Jefferson Medical College in Philadelphia. He was an NIH
`
`fellow in endocrinology, diabetes, and metabolic disease at Jefferson and a fellow
`
`in clinical pharmacology at St. Vincent’s Hospital and Medical Center in New
`
`York City. Dr. DeFelice was the former Chief of Clinical Pharmacology at the
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`Walter Reed Army Institute of Research (WRAIR). He was a member of the
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`Harvard School of Public Health’s International Faculty on the Management of
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`Biomedical Research and the Tufts’ Faculty on the Principles of Clinical Research.
`
`He was also a member of the team that brought lithium into the United States and
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`was the doctor responsible for its launch. His 40-year experience with carnitine, a
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`naturally occurring substance with multiple medical benefits, sparked his interest
`
`and determination to encourage medical discovery. Largely through his efforts, it
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`is now FDA approved as an Orphan Drug for various types of carnitine
`
`deficiencies as well as for renal dialysis patients. He is currently involved in
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`clinical research on carnitine in ovarian cancer patients. His experience taught him
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`that the promise of medical technology is exploding but the barriers, costs, and
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`risks of clinically testing their promise, a critical step in medical discovery, are also
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`exploding.
`
`Lyle E. Craker, PhD is a Professor in the Department of Plant, Soil, and
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`Insect Sciences at the University of Massachusetts, and Executive Editor of the
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`Journal of Medicinally Active Plants. Since 2005, Dr. Craker has been trying to
`
`obtain a permit from the United States Drug Enforcement Administration to grow
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`marijuana for research purposes. Dr. Craker holds a B.S. degree in agronomy from
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`the University of Wisconsin, Madison and a Ph.D. in agronomy and plant genetics
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`with a specialty in plant physiology from the University of Minnesota. Dr. Craker
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`is known for proposing that medical grade marijuana be available for scientific
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`studies into its possible health benefits. Dr. Craker serves as the editor of “The
`
`Journal of Herbs, Spices, and Medicinal Plants,” and past Editor, Past-Chairman of
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`International Society for Horticultural Science Section on Medicinal and Aromatic
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`Plants.
`
`Daniela Vergara, PhD is an evolutionary biologist researching cannabis
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`genomics at the University of Colorado Boulder. In addition to her multiple
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`publications on cannabis, she founded and directs a non-profit organization, the
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`Agricultural Genomics Foundation (AGF). AGF’s aim is to make cannabis
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`science available to a broad public. Dr. Vergara’s latest scientific publications
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`include the comparison of the federal cannabis to that produced by the private
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`market, showing that the government’s cannabis lacked potency and variation.
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`These results were featured in news platforms such as Science and
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`FiveThirtyEight. Some of her other scientific publications are a compilation on the
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`existing genomic tools available for cannabis research, and the maternally inherited
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`genomes (chloroplast and mitochondria). Dr. Vergara has authored these
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`publications advised by Dr. Nolan Kane whose group at CU Boulder she joined in
`
`2013. These publications are a product of collaborations between graduate and
`
`undergraduate students, and scientists from the cannabis industry.
`
`Christopher J. Hudalla, PhD is analytical chemist with more than 30 years
`
`of research experience in analytical chemistry, spectroscopy, and chromatographic
`
`method development. He is recognized worldwide as an expert in the field of
`
`traditional Reverse Phase Liquid, Supercritical Fluid, and Convergence
`
`Chromatography and an active leader in the development and implementation of
`
`the UltraPerformance Convergence Chromatography instrumentation. Dr. Hudalla
`
`is the founder and Chief Scientific Officer of ProVerde Laboratories, Inc., a
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`premier analytical testing, CO2 extraction and derivative product formulation
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`consultancy for the regulated medical cannabis and hemp industries. ProVerde is
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`among the first laboratories in the United States to receive an ISO 17025
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`accreditation that specifically governs hemp and medical cannabis testing.
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`ProVerde Laboratories operates at the cutting edge of medical cannabis extraction,
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`purification and product formulation techniques, supported by expert analytical
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`testing, with expertise that will move research into cannabis and its effects on
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`various medical conditions forward as the medical cannabis industry progresses.
`
`Dr. Hudalla plays an integral part in providing clients operating in the Medical
`
`Marijuana and hemp industries the ability to deliver new products and product
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`formulations that meet the highest standards for quality, consistency, safety and
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`labeling. Dr. Hudalla received his M.S. and Ph.D. from the University of
`
`California at Santa Barbara and was a Postdoctoral Fellow at the Eppley Institute
`
`for Cancer Research within the University of Nebraska Medical Center. Dr.
`
`Hudalla has delivered presentations all over the world in his areas of expertise,
`
`including analytical testing and research specific to medical cannabis and serves on
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`the Cannabis Expert Panel with the United States Pharmacopeia (USP).
`
`Rachna Patel, MD is a world recognized expert in the field of cannabinoid
`
`medicine. She offers consultations and courses, so that people can relieve their
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`symptoms, transform their health, and live a better quality life with cannabinoid
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`products. She consults with patients about how to use cannabinoid products and
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`what to expect when using cannabinoid products, while also dispelling fears people
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`may have about these treatments and putting their minds at ease. Dr. Patel
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`completed her undergraduate studies at Northwestern University in Chicago,
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`Illinois and earned her medical degree from Touro University in Vallejo,
`
`California. Dr. Patel has been interviewed on over 200 podcasts, has taken the
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`stage internationally to spread awareness regarding the health benefits of
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`cannabinoid products, has been featured in articles for Lifehacker and
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`MindBodyGreen, and has appeared on major news networks such as NBC. She
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`also authored the book, The CBD Oil Solution: Treat Chronic Pain, Anxiety,
`
`Insomnia and more without the High.
`
`Maureen Leehey, MD is a Professor of Neurology and Chief of the
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`Movement Disorders Division at the University of Colorado Denver and a Fellow
`
`Member of the American Academy of Neurology. She specializes in movement
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`disorders and Fragile X associated disorders and sub-specializes in movement
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`disorders and Botox therapy. She sees patients at the University of Colorado
`
`Hospital Anschutz Centers for Advanced Medicine. She is board certified in
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`Neurology and Psychiatry, and is a fellowship-trained movement disorders
`
`specialist. She is the senior movement disorders neurologist in the Rocky
`
`Mountain region and has mentored numerous neurologists. During her 29 years at
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`the University of Colorado, she has managed thousands of patients with
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`Parkinson's disease, is Lead Investigator in the International Parkinson Disease
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`Study Group, and has been the Primary Investigator for over 20 Parkinson's disease
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`clinical trials.
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` Wendy and Tom Turner are the founders of the Coltyn Turner
`
`Foundation, a non-profit research organization dedicated to researching therapeutic
`
`uses of medical cannabis. The first patient of the Coltyn Turner Foundation was
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`their son, Coltyn, who was the first pediatric Crohn’s patient in the United States to
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`find clinical remission using cannabis.
`
`Camille Stewart, MD is an Assistant Professor, Surgery-Surgical Oncology
`
`at the University of Colorado School of Medicine. Dr. Stewart is a Diplomate of
`
`the American Board of Surgery and was trained in general surgery at the
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`University of Colorado in Aurora, Colorado, and in Complex General Surgical
`
`Oncology at City of Hope in Duarte, California.
`
`*
`
`*
`
`*
`
`The statements contained in this brief represent the personal beliefs and
`
`opinions of the amici curiae. They do not represent the beliefs or opinions of the
`
`institutions that employ the amici curiae or with which they are affiliated,
`
`including without limitation the University of Colorado Anschutz Medical
`
`Campus.
`
`Respondents have consented to the filing of this brief.
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`TABLE OF CONTENTS
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`Page
`
`TABLE OF AUTHORITIES ................................................................................... ix
`STATEMENT OF AUTHORSHIP AND FINANCIAL CONTRIBUTIONS ......... 1
`SUMMARY OF ARGUMENT ................................................................................. 2
`ARGUMENT ............................................................................................................. 4
`I.
`Schedule I Classification and DEA Inaction Has Obstructed
`Meaningful Research on Medical Cannabis ......................................... 4
`A.
`The Schedule I Classification Arbitrarily Restricts
`Cannabis Research ...................................................................... 5
`The Practical Reality of Clinical Research Under
`Schedule I .................................................................................... 9
`Conclusive Evidence Shows Medically-Accepted Uses
`for Cannabis ..............................................................................12
`The DEA’s 2020 Denial Was an Abuse of Discretion, and the
`Court Should Order the DEA to Initiate Rulemaking
`Proceedings In Light of the Medically-Accepted Uses Set Out
`Above. .................................................................................................16
`CONCLUSION ........................................................................................................20
`CERTIFICATE OF SERVICE ................................................................................22
`CERTIFICATE OF COMPLIANCE .......................................................................23
`
`B.
`
`C.
`
`II.
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`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Inland Empire Pub. Lands Council v. Glickman,
`88 F.3d 697 (1996) .............................................................................................. 19
`Morall v. DEA,
`412 F.3d 165 (D.C. Cir. 2005) ...................................................................... 18, 19
`Motor Vehicle Mfrs. Ass’n of the U.S. v. State Farm Mut. Auto. Ins. Co.,
`463 U.S. 29 (1983) .............................................................................................. 19
`Tourus Records, Inc. v. DEA,
`259 F.3d 731 (D.C. Cir. 2001) ............................................................................ 18
`Statutes
`21 U.S.C.S.
`811 ....................................................................................................................... 17
`812 ....................................................................................................................... 17
`5 U.S.C.
`§ 706(2)(A) ......................................................................................................... 18
`§ 706(2)(D) ......................................................................................................... 18
`21 U.S.C.
`§ 811(a) ......................................................................................................... 19, 20
`§ 812 ...................................................................................................................... 4
`§ 812(b) ................................................................................................................. 4
`§ 812(b)(1) .......................................................................................................... 12
`§ 812(b)(1)(A) ....................................................................................................... 5
`§ 812(b)(1)(B) ....................................................................................................... 5
`§ 812(b)(1)(C) ....................................................................................................... 5
`§ 812(b)(2)(B) ....................................................................................................... 5
`§ 812(b)(5)(A) ....................................................................................................... 4
`§ 822(a)(1) ............................................................................................................ 6
`§ 822(f) .................................................................................................................. 6
`§ 823(a)-(f) ............................................................................................................ 6
`§ 823(f) .................................................................................................................. 6
`§ 877 .................................................................................................................... 18
`Controlled Substances Act ................................................................................passim
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`Regulations
`21 C.F.R.
`§ 1301.75(a) .......................................................................................................... 7
`§ 1316.13 ............................................................................................................... 7
`80 Fed. Reg. 75692-02 (2015) ................................................................................... 9
`81 Fed. Reg. 53846 (Aug. 12, 2016).......................................................................... 8
`84 Fed. Reg. 44920–23 .............................................................................................. 8
`Other Authorities
`Britt E. Erickson, Chemical & Engineering News (June 29, 2020) .......................... 9
`Charles W. Webb, M.D. & Sandra M. Webb, RN, BSN, Therapeutic
`Benefits of Cannabis: A Patient Survey, 73 Hawaii J. Med. &
`Public Health 109-11 (Apr. 2014) ...................................................................... 13
`Department of Justice, “DEA Announces Steps Necessary to Improve
`to Marijuana Research” ........................................................................................ 8
`Drug Scheduling, U.S. Drug Enforcement Admin. ................................................... 4
`Francois Gueyffier & Michael Cucherat, The Limitations of
`Observation Studies for Decision Making Regarding Drugs
`Efficacy and Safety, Therapies (Vol. 74, Iss. 2 2019) ........................................ 11
`Jonathan N. Adler & James A. Colbert, Medicinal Use of Marijuana –
`Poling Results, 2013 New Eng. J. Med. 368 (May 2013) .................................. 13
`Letter from Dr. Tedros Adhanom Ghebreyesus, Director-General, WHO,
`to António Guterres, Secretary-General, United Nations (Jan. 24, 2019) .......... 15
`Mike Stone, Esq. & Professor Jason Robert, Ph.D., The Cannabis
`Catch-22: DEA Suffocates Cannabis Research Because We Don’t
`Understand Cannabis, 47 S.U. L. Rev. 383, 402–03 (2020) ................... 4, 10, 14
`NAT’L CONFERENCE OF STATE LEGISLATURES, STATE MEDICAL
`MARIJUANA LAWS (March 10, 2020) .................................................................. 12
`NCCIH, Cannabis (Marijuana) and Cannabinoids: What You Need to Know ...... 16
`
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`STATEMENT OF AUTHORSHIP AND FINANCIAL CONTRIBUTIONS
`
`No party’s counsel authored the brief in whole or in part, no party or party’s
`
`counsel contributed money that was intended to fund preparing or submitting the
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`brief, and no person, other than the above referenced amicus, and their counsel,
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`contributed money that was intended to fund preparing or submitting this brief.
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`SUMMARY OF ARGUMENT
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`Schedule I classification of cannabis under the Controlled Substances Act
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`(CSA) materially and significantly limits the ability of researchers to continue to
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`undertake research necessary to test therapeutic uses within the medical and
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`scientific community.
`
`Among other things, Schedule I classification severely limits the availability
`
`of research material available for scientific research to only cannabis products
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`approved by the United States Drug Enforcement Administration (DEA) and the
`
`National Institute on Drug Abuse (NIDA), which currently consist only of
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`cannabis grown and processed by the University of Mississippi. When researchers
`
`are able to obtain federally sanctioned cannabis, it is dissimilar in potency and
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`formulation from cannabis products widely used by patients and other consumers,
`
`undermining the reliability of scientific research. Restrictions on storage and
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`control of cannabis necessitate the purchases of specialized equipment, such as
`
`double-locked refrigerators, which increase the expense of cannabis research
`
`without any material benefit. Despite this, scientific and medical communities
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`have made great strides in cannabis research. Since 2016, multiple national
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`collectives of scientists and doctors, including the National Academies of Sciences,
`
`Engineering, and Medicine (the “National Academies”) and the National Center
`
`for Complementary and Integrative Health (NCCIH), a branch of the National
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`Institutes of Health for the Department of Health and Human Services, have
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`acknowledged the “conclusive” and “substantial” benefits of medical cannabis,
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`including in the context of managing chemotherapy care and side effects, chronic
`
`pain management, and the management of multiple sclerosis. This scientific
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`research post-dates the August 12, 2016 (the “2016 Denial”) proceedings before
`
`the Federal Register, on request from the Hon. Lincoln D. Chafee and the Hon.
`
`Christine O. Gregoire in a petition dated November 30, 2011 to initiate rulemaking
`
`proceedings under the rescheduling provisions of the CSA—precisely what
`
`Petitioners do here. 1ER 2. The 2016 Denial served as the sole basis for the
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`Department of Justice’s 2020 summary denial, which gives rise to Petitioner’s
`
`appeal here. Id.
`
`Because the Government failed to consider an important aspect of the
`
`scheduling of cannabis (i.e., prevailing and evolved research and widespread
`
`medical acceptance) when denying the petition, this Court should reverse the
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`Government’s denial of the petition and order that the DEA initiate rulemaking
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`proceedings that include consideration of the post-2016 evidence, which is clearly
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`inconsistent and irreconcilable with a Schedule I classification.
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`ARGUMENT
`
`I.
`
`Schedule I Classification and DEA Inaction Has Obstructed Meaningful
`Research on Medical Cannabis
`To understand the research implications of the Schedule I classification, a
`
`brief primer of the CSA is in order. The CSA regulates, among other things, the
`
`way drugs are scheduled based on several factors, including a drug’s susceptibility
`
`for abuse and/or dependence, compared with the drug’s medicinal value when used
`
`properly. 21 U.S.C. § 812.
`
`The CSA classifies drugs on a five-category schedule, based on medical and
`
`scientific data regarding the potential uses and abuses of the drug, which are
`
`analyzed by the Food & Drug Administration and the NIDA. Drug Scheduling,
`
`U.S. Drug Enforcement Admin., https://www.dea.gov/drug-scheduling (last visited
`
`Oct. 6, 2020). Drugs are classified on Schedules I to V, with V being the safest,
`
`and accordingly the least regulated, and I being the most highly controlled. Mike
`
`Stone, Esq. & Professor Jason Robert, Ph.D., The Cannabis Catch-22: DEA
`
`Suffocates Cannabis Research Because We Don’t Understand Cannabis, 47 S.U.
`
`L. Rev. 383, 402–03 (2020). For a drug to be classified as a Schedule V drug, it
`
`must have a low potential for abuse. 21 U.S.C. § 812(b)(5)(A). Potential for abuse
`
`is a relative factor, meaning Schedule V drugs must have a low potential for abuse
`
`as compared to Schedule IV drugs. Id. at § 812(b). Conversely, for a drug to be
`
`classified as Schedule I, that drug or other substance must meet three criteria.
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`First, that drug must have a “high potential for abuse.” Id. § 812(b)(1)(A).
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`Second, that drug must have “no currently accepted medical use in treatment in the
`
`United States.” Id. at § 812(b)(1)(B). Lastly, “[t]here is a lack of accepted safety
`
`for use of the drug or other substance under medical supervision.” Id. at
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`§ 812(b)(1)(C). The second and third requirements diverge from the standards for
`
`all other controlled drugs, all of which have “currently accepted medical use[s],”
`
`even if they come with “severe restrictions.” Id. at § 812(b)(2)(B).
`
`A.
`
`The Schedule I Classification Arbitrarily Restricts
`Cannabis Research
`Schedule I classification materially restricts the amount and type of research
`
`that can be conducted on all Schedule I controlled substances, including cannabis.
`
`The practical effect of these limitations is that experienced and qualified
`
`researchers who seek to study the effects of cannabis—particularly the type of
`
`cannabis that is commercially available in state-legal, medical cannabis markets—
`
`are forced to wade through a complex regulatory scheme that imposes time-
`
`consuming, costly, and arbitrary requirements. Given what we now know about
`
`commercially and medically available cannabis under state-legal regulatory
`
`regimes, there is no legitimate reason for such onerous restrictions, which serve no
`
`purpose other than to impede meaningful re-evaluation of research that would
`
`support the scheduling of cannabis.
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`Under the CSA, all persons—including physicians and researchers—who
`
`seek to manufacture or distribute any controlled substance must apply for a DEA
`
`registration. See 21 U.S.C. § 822(a)(1). The CSA directs the DEA to grant
`
`registration if it would be “consistent with the public interest,” outlining the criteria
`
`the DEA must consider when evaluating the public interest. See id. §§ 823(a)-(f).
`
`The criteria vary depending on (1) whether the applicant is a manufacturer,
`
`researcher, or practitioner; and (2) the classification of the controlled substance
`
`that is the focus of the application. Id. Applicants who seek to research Schedule I
`
`controlled substances face the most time-consuming registration process:
`
`Registration applications by practitioners wishing to conduct research
`with controlled substances in schedule I shall be referred to the
`Secretary, who shall determine the qualifications and competency of
`each practitioner requesting registration, as well as the merits of the
`research protocol. The Secretary, in determining the merits of each
`research protocol, shall consult with the Attorney General as to
`effective procedures to adequately safeguard against diversion of such
`controlled substances from legitimate medical or scientific use.
`Id. § 823(f). In other words, a researcher seeking to conduct a cannabis-related
`
`study must wait several months, if not longer, just to obtain a DEA registration.
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`The hurdles and limitations do not stop at the application stage. Researchers
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`of Schedule I controlled substances are subjected to frequent, disruptive
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`inspections. See id. § 822(f). While it is the intent of the DEA to inspect
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`distributors of Schedule II through V controlled substances “as circumstances may
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`require,” distributors of controlled substances listed in Schedule I are subject to
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`inspections as frequent as “once each year.” 21 C.F.R. § 1316.13.
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`Cannabis researchers are also subjected to onerous storage requirements, as
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`cannabis must be stored “in a securely locked, substantially constructed cabinet.”
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`See id. § 1301.75(a). As a practical matter, this requirement is typically only
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`satisfied through the use of specialized, approved equipment that typically runs
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`approximately $15,000 for a refrigeration and storage device. This requirement
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`adds another extraordinary administrative expense that would be unnecessary if
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`cannabis was appropriately de- or re-scheduled.
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`Finally, and most problematic, cannabis researchers are required to use a
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`specific type of cannabis that does not reflect the type of cannabis that consumers
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`actually purchase and consume.
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`Since 1968, the National Center for Natural Products Research at the
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`University of Mississippi has held the sole registration and government contract to
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`grow cannabis for research purposes. Generally containing the equivalent of
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`6–12% Tetrahydrocannabinol (THC) by weight, this plant material differs
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`considerably from cannabis products widely used by the public, which have a
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`potency equivalent of 18 to 25% THC (or higher). 4ER827–33; see also Pet. Br. at
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`37. In addition, this product is usually subject to long periods of storage, which
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`further results in potency loss. 4ER827–33; Pet. Br. at 37–38.
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`Case: 20-71433, 10/06/2020, ID: 11850010, DktEntry: 30, Page 19 of 34
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`Recognizing the legitimate need to facilitate cannabis research and the
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`research limitations imposed by the cannabis product from the University of
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`Mississippi, in August 2016, the DEA issued a Policy Statement indicating that it
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`intended to increase the number of entities allowed to grow cannabis to supply to
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`researchers in the United States. See 81 Fed. Reg. 53846 (Aug. 12, 2016). Three
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`years later, the DEA announced that it would provide notice of pending
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`applications from entities applying to be registered to manufacture marijuana for
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`researchers. See Department of Justice, “DEA Announces Steps Necessary to
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`Improve to Marijuana Research,” available at https://www.justice.gov/opa/pr/dea-
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`announces-steps-necessary-improve-access-marijuana-research; see also 84 Fed.
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`Reg. 44920–23. But in that same notice, the DEA expressly stated that “[b]efore
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`making decisions on these pending applications, DEA intends to propose new
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`regulations that will govern the marijuana growers program for scientific and
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`medical research.” Id.
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` Over four years have passed since the DEA issued this Policy Statement and
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`dozens of growers and manufacturers have applied for a registration. Yet, despite
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`these efforts, no new licenses have been granted. Pet. Br. at 40. Under the current
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`scheme—a scheme exacerbated by DEA inaction—cannabis researchers are forced
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`to rely on cannabis products dissimilar in potency and formulation from cannabis
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`products widely used by patients and other consumers.
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`De-scheduling or, alternatively, appropriate re-scheduling of cannabis would
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`remove many of the unnecessary administrative obstacles imposed by the DEA’s
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`regulations.
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`The Practical Reality of Clinical Research Under Schedule I
`B.
`The classification of cannabis as a Schedule I controlled substance erects a
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`plethora of unnecessary obstacles to even research cannabis, which, in turn,
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`obstruct the ability of the medical and scientific community to demonstrate that
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`cannabis does, in fact, have accepted medical use in the United States.
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`Perhaps due to its classification as a Schedule I controlled substance,
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`cannabis research is severely underfunded. If a researcher is lucky enough to
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`receive funding to conduct a cannabis-