High Time for a Change: Implications of DEA’s Proposed Marijuana Rescheduling
Recorded June 12, 2024 On-Demand Webinar
Overview
On May 16, the Justice Department submitted a proposed regulation to reschedule marijuana. Now that this long-anticipated step has been taken, what can stakeholders expect? Panelists will dissect the proposed rule, then address potential implications for the cannabis products industry, state regulation, cannabis research, and social justice and equity.
Srikumaran Melethil |
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Professor Emeritus, University of Missouri-Kansas City
Biography
SRIKUMARAN “SRI” MELETHIL, Ph.D., J.D., is a pharmaceutical scientist and professor emeritus, University of Missouri-Kansas City. He is also an attorney, admitted to the Missouri Bar, the United States Courts for the Western District of Missouri, and the United States Patent and Trademark Office (as a registered patent attorney).
His scientific expertise covers the area of pharmaceutical sciences (pharmacokinetics, pharmacodynamics, drug delivery, generic drugs, clinical pharmacology and drug analysis); he has conducted research and published extensively in this area. In the legal arena, he has primarily focused on topics at the interface of science and law; he haspublished articles on the regulation of dietary supplements, World Anti-Doping Agency inclusion criteria for prohibited substances, biosimilars, and drug patent litigation arising under the Hatch-Waxman Act. He has also offered short courses and published book chapters on drug and patent law to promote understanding of these areas among life scientists. He also spoke on the conflict of state and federal marijuana laws and regulation at a FDLI sponsored conference in Washington, DC in 2018.
Dr. Melethil has served or serves as a consultant/reviewer to the pharmaceutical industry andfederal agencies (FDA/CVM), EPA (Human Studies Research Board), National Institute of Environmental Health Sciences, and National Institute of Drug Abuse, and has provided expert witness testimony/affidavits in drug toxicity, marijuana and probenecid pharmacokinetics, blood alcohol, and death penalty(lethal injection) cases.
He is a Fellow of the American Association of Pharmaceutical Scientists, the premier association of his peers, and the American College of Clinical Pharmacology. He serves on the Editorial Boards of Clinical Research and Regulatory Affairs and Pharmaceutical Patent Analyst. Dr. Melethil received his B. Pharmacy (First Class, First Rank, Gold Medalist), and M. Pharmacy (Manufacturing Pharmacy, First Class) from Andhra University, Waltair, India; his Ph.D. degree in pharmaceutical sciences from the Department of Pharmaceutics (now Pharmaceutical Sciences), State University of New York at Buffalo; and his Juris Doctor degree from the University of Missouri-Kansas City School of Law.
Deborah Miran | Read Bio
Principal, DMiran Consulting
Biography
DEBORAH MIRAN, former commissioner, was a member of the Natalie M. LaPrade Maryland Medical Cannabis Commission from 2013- 2016. While serving on the commission, she was also a member of the executive committee, policy, and research subcommittees, and was chair of the education subcommittee. She was responsible for developing education programs for doctors and patients, and was also an integral part of crafting the current regulations. Prior to the commission she was president and founder of Miran Consulting, Inc. There she advised both brand and generic drug makers on the FDA approval process. Ms. Miran was senior director of regulatory affairs for Alpharma, a generic drug manufacturer, where she directed the submission activities for new and abbreviated new drug applications to the FDA. She has spent over 30 years in the U.S. pharmaceutical industry. Ms. Miran received her bachelor of science in chemistry from Iowa State University.
Lila McKinley | Read Bio
Legal Programs Director, Connecticut Department of Consumer Protection
Biography
LILA MCKINLEY currently serves as a Legal Program Director for the Department of Consumer Protection. In that capacity, Ms. McKinley oversees a unit comprised of attorneys and paralegals responsible for drafting regulations, statutes, and providing general legal advice in the areas of pharmaceutical, adult-use cannabis and medical cannabis laws and regulations. She assisted the Department in its legislative and regulatory initiatives and overall successful roll-out of the state’s adult-use cannabis program.
Prior to joining the Department of Consumer Protection in 2014, Ms. McKinley practiced at a large insurance defense law firm for five years in the areas of professional liability and legal malpractice.
Ms. McKinley obtained her J.D. from the University of Connecticut School of Law and her B.A. in Political Science and Sociology from the University of Connecticut.
Larry K. Houck | Read Bio
Director, Hyman, Phelps, & McNamara PC
Biography
LARRY K. HOUCK is a director at Hyman, Phelps & McNamara PC where he provides counsel on regulatory and enforcement actions by the DEA. His career encompasses over 30 years of conducting investigations and negotiating on behalf of both the government and industry. Mr. Houck focuses on controlled substances, prescription drugs, and regulated chemicals, helping clients navigate federal and state licensing, registration, and compliance issues. Mr. Houck counsels clients throughout the registrant supply chain on administrative, civil, and criminal proceedings. In situations where clients face enforcement action, Mr. Houck has extensive understanding of the DEA’s approach and priorities. He advises pharmaceutical and chemical companies on DEA inspections and audits. By working with clients to review business practices, he helps create the infrastructure to ensure compliant reporting, record keeping, and security. Before joining Hyman, Phelps & McNamara in 2001, Mr. Houck served as a DEA diversion investigator and policy staff coordinator. As a diversion investigator in the Washington, DC and Portland, Oregon field offices, Mr. Houck conducted a full range of regulatory and criminal investigations and inspections of controlled substance and chemical registrants. While serving as a staff coordinator for the DEA’s Office of Diversion Control’s Liaison and Policy, he advised government officials and pharmaceutical and health care professionals on the Controlled Substance Act and its regulations. Mr. Houck drafted and helped implement the DEA’s controlled substance policies and regulations on diversion control issues that included pain management.
Robert Mikos | Read Bio
La Roche Family Chair in Law, Vanderbilt University School of Law
Biography
ROBERT MIKOS is one of the nation’s leading authorities on cannabis law and policy. He has published, consulted, and lectured extensively on competing approaches to regulating cannabis and the struggles among federal, state, and local officials for control of this quickly evolving policy domain. Mikos holds the LaRoche Family Chair in Law at Vanderbilt University Law School, where he teaches courses in federalism, constitutional law, and cannabis law and policy. Professor Mikos has also taught at the University of Michigan, the University of Notre Dame, and the University of California, Davis. He earned his A.B. cum laude from Princeton University and his J.D. summa cum laude from the University of Michigan. After graduation from law school, Mikos clerked for Chief Judge Michael Boudin of the U.S. Court of Appeals for the First Circuit.
Moderated by
Jonathan A. Havens |
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Partner, Saul Ewing LLP
Biography
JONATHAN HAVENS is the Managing Partner of Saul Ewing LLP’s Baltimore office, and serves as co-chair of both the firm’s Cannabis Law and its Food, Beverage & Agribusiness Practices. Companies in the cannabis, life sciences, food and beverage, and cosmetics industries turn to Jonathan for advice on how to get and keep their products on the market. Since 2019, Chambers USA has recognized Jonathan as one of America’s leading lawyers in cannabis law. In 2021, Law360 selected Jonathan as a cannabis law rising star. He is regularly interviewed by mainstream and trade press outlets, alike, and has been quoted by or authored pieces for The New York Times, The Los Angeles Times, Reuters, CNBC, WIRED, MarketWatch, Engadget, Law360, High Times Magazine, and Marijuana Business Daily. Jonathan began his legal career as a regulatory counsel with the U.S. Food and Drug Administration, and prior to law school, he served as a legislative aide in both the U.S. Senate and U.S. House of Representatives.
