July 14, 2020

Volume X, Number 196

July 14, 2020

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July 13, 2020

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DEA Releases Draft Rules Related to Cannabis Medical Research

The U.S. Drug Enforcement Agency (DEA) released a draft rule titled Controls to Enhance the Cultivation of Marihuana for Research in the United Stateswhich seeks to amend its regulations to comply with the Controlled Substances Act (CSA) and “facilitate research that could result in the development of marihuana-based medicines approved by the Food and Drug Administration (FDA).” If adopted, this draft rule would replace the 2016 DEA rule, Applications To Become Registered Under the Controlled Substances Act To Manufacture Marijuana To Supply Researchers in the United States.

Under the CSA, manufacturers of controlled substances must obtain a DEA registration to plant, cultivate, grow, or harvest marihuana to supply researchers and other permissible uses. In the draft rule, the DEA identifies three types of potential manufacturers who may apply for registration:

  1. Manufacturers who use their marihuana crop for internal research purposes;

  2. Manufacturers who grow marihuana for uses by other DEA registrants, including researchers funded by the National Institutes of Health (NIH); and

  3. Manufacturers who supply marihuana to support the National Institute on Drug Abuse (NIDA) program.

The proposed rule would require all registered manufacturers to notify the DEA of its proposed harvest date and deliver their total cannabis crop to the DEA. The DEA would then have the exclusive right to import, export, wholesale trade, and maintain stock of such cannabis.

This proposed rule is important because it will ensure an adequate and uninterrupted supply of marihuana for medical research, as well as allow for a more diverse variety of strains. In addition to the expansion of growers, the quota for production of marihuana also will increase to 3,200 kilograms. Applicants will be evaluated based on their ability to “consistently produce and supply marihuana of a high quality and defined chemical composition,” and ensure the applicant can comply with CSA and DEA regulations.  

This research is critically important to increase medical research of cannabis and cannabis-derived products. To date, the only natural medical cannabis product approved by the FDA is Epidiolex, a purified form of cannabidiol (CBD) to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome. Additionally, the FDA has approved Marinol, Syndros and Cesamet, which contain synthetic forms of tetrahydrocannabinol (THC), a component of cannabis products, to treat conditions such as nausea and vomiting caused by cancer chemotherapy and loss of appetite and weight loss in people with HIV/AIDS.

The Center for Medicinal Cannabis Research in California and the University of Mississippi are examples of institutions advancing the science of medical cannabis, studying the pain benefits of tinctures, treatment of autistic children, neuropathic pain, multiple sclerosis treatment, and other conditions. In addition, in 2019, the NIH funded over $3 million for studies at Boston Children’s Hospital for a CBD mediated analgesic, a University of California study for minor cannabinoid treatment of inflammatory and neuropathic pain, and a NY University School of Medicine study of mechanisms of action for CBD on chronic arthritis pain. 

Comments to the draft rule are due by May 22, 2020. Manufacturers and other interested parties should carefully review the draft rule and consider submitting comments to the DEA.

© 2020 Dinsmore & Shohl LLP. All rights reserved.National Law Review, Volume X, Number 85

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About this Author

Jennifer K. Mason Partner Dinsmore Lewisburg Pittsburgh  Insurance Industry Natural Resources Industry Litigation Tort
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Jennifer represents clients in construction, insurance, corporate and commercial litigation, and appellate matters in federal and state courts in West Virginia and Pennsylvania. Her experience in litigation includes construction disputes, professional liability of architects and engineers, construction defect, insurance, contractual and commercial disputes, transportation matters, mergers and acquisitions, breach of contract matters, product liability cases, energy, and general catastrophic loss litigation.

She has taken more than 40 cases to trial and argued appellate matters in...

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Sarah K. diFrancesca Healthcare Attorney Dinsmore & Shohl Law Firm Cincinnati
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Sarah is an essential resource for individuals and companies navigating the ever-changing industries of health care and life sciences. Her practice focuses on complex health care litigation, investigations, regulatory compliance, and fraud and abuse. When clients develop new technologies or have questions about evolving government standards, she counsels them on how to meet their businesses’ objectives while ensuring compliance with the law. Sarah holds a degree in biology and worked with a pharmaceutical consulting firm early in her career, serving as the independent review organization (IRO) for a top pharmaceutical company. Her science background paired with her legal experience offers clients and their in-house counsel a second set of eyes – and options – when dealing with complex regulatory challenges. Sarah’s clients include clinical and commercial pharmaceutical, biotechnology, and medical device companies and clinical laboratories, as well as individuals in the health care space, such as physicians and sales representatives. Her experience includes defending health care and life sciences companies and individuals in criminal and civil False Claims Act investigations regarding complex government theories of health care fraud, false claims, misbranding, off-label promotion and kickbacks. This includes negotiating and implementing settlements and corporate integrity agreements, and advising clients on regulatory self-disclosures. 

Her expertise also involves advising companies on the Anti-Kickback Statute, fraud and abuse laws, FDA and regulatory compliance matters, transparency laws, and industry codes of conduct. This includes conducting internal compliance investigations, advising on promotional practices, implementing and improving corporate compliance programs, compliance auditing and monitoring, and transactional diligences. Sarah counsels boards of directors, compliance committees, and management executives on compliance and regulatory issues. She also develops and conducts compliance training programs for sales representatives, promotional review committees, and management teams.

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