This Teachable Moment: How COVID-19 Provides Lessons from FDA’s Past and Present That Will Benefit Its Future Preparedness Food and Drug Law Journal 2020 Symposium November 12–13 | Virtual Event This Teachable Moment: How COVID-19 Provides Lessons from FDA’s Past and Present That Will Benefit Its Future Preparedness Food and Drug Law Journal 2020 Symposium November 12–13 | Virtual Event TABLE OF CONTENTS AGENDA SPEAKER BIOGRAPHIES ATTENDEE LIST Food and Drug Law Journal 2020 Symposium This Teachable Moment: How COVID-19 Provides Lessons from FDA’s Past and Present That Will Benefit Its Future Preparedness November 12–13, 2020 Virtual Event Agenda THURSDAY, NOVEMBER 12, 2020 12:00–12:15 PM Welcome Announcements Amy Comstock Rick, President & CEO, FDLI Paige Samson, Director, Innovative Programs and Publications, FDLI 12:15–12:45 PM Keynote Address Dr. Anand Shah, Deputy Commissioner for Medical and Scientific Affairs, Office of the Commissioner, FDA Lowell Zeta, Senior Counselor to the Commissioner, Office of the Commissioner, FDA 12:45–12:50 PM Break 12:50–2:20 PM Paper Presentations Topic: “History, Legislative Innovation, and Future Pandemics” Daniel A. Kracov, Arnold & Porter and Vice Chair, FDLI Board of Directors Topic: “Agencies Unbound: How COVID-19 Prompted Regulatory Flexibility and How to Build on it for the Future” Brian D. Eyink, Elizabeth B. Fawell, Steven B. Steinborn, and Anneke Baran Altieri, Hogan Lovells US LLP Moderator: Laurie Beyranevand, Vermont Law School Discussant: Kalah Auchincloss, Greenleaf Health, Inc. 2:20–2:30 PM Break 2:30–3:15 PM Paper Presentation Topic: “The American Pharmaceutical Supply Chain: Will COVID-19 Drive Manufacturing Back Home?” Gregory H. Levine, Jenna McCarthy*, and Beth P. Weinman, Ropes & Gray LLP and Grant Sims*, NYU Stern School of Business Moderator: Marian J. Lee, Gibson, Dunn & Crutcher LLP © 2020 by the Food and Drug Law Institute (FDLI) *Author is not presenting at the FDLJ 2020 Symposium 1 Food and Drug Law Journal 2020 Symposium This Teachable Moment: How COVID-19 Provides Lessons from FDA’s Past and Present That Will Benefit Its Future Preparedness November 12–13, 2020 Virtual Event Agenda Discussant: Ralph F. Hall, University of Minnesota Law School and Leavitt Partners, LLC 3:15–3:30 PM Break 3:30–5:00 PM Paper Presentations Topic: “Vaccine-Related Liability: Past Approaches, Current Challenges, and Proposals for Encouraging Future Innovation and More Widespread Vaccine Use” Camille L. Fletcher, Greg Margolis*, and John D. Winter, Patterson, Belknap, Webb & Tyler LLP Topic: “A Test of the Emergency (Use Authorization) System: Challenges in FDA Regulation of COVID-19 Diagnostics” Jeffrey N. Gibbs, and Gail H. Javitt*, Hyman, Phelps & McNamara, P.C. Moderator: James T. O’Reilly, University of Cincinnati, and Chair, Food and Drug Law Journal Editorial Advisory Board Discussant: J.R. McNair, Winston & Strawn LLP 5:00–5:30 PM Networking Event FRIDAY, NOVEMBER 13, 2020 12:00 PM Welcome Remarks Sonia L. Canzater, Senior Associate, Hepatitis Policy Project, O’Neill Institute for National and Global Health Law, Georgetown University Law Center Paige Samson, Director, Innovative Programs and Publications, FDLI 12:00–1:30 PM Paper Presentations Topic: “How We Got Here: FDA Emergency Use Authorization from 9/11 to COVID-19” Jonathan Iwry, Harvard Law School © 2020 by the Food and Drug Law Institute (FDLI) *Author is not presenting at the FDLJ 2020 Symposium 2 Food and Drug Law Journal 2020 Symposium This Teachable Moment: How COVID-19 Provides Lessons from FDA’s Past and Present That Will Benefit Its Future Preparedness November 12–13, 2020 Virtual Event Agenda Topic: “Assessing COVID-19 Emergency Use Authorizations” Efthimios Parasidis, Patricia J. Zettler*, and Micah Berman*, The Ohio State University Moderator: Joseph Page, Georgetown University Discussant: Nathan A. Brown, Akin Gump Strauss Hauer & Feld LLP 1:30–1:45 PM Break 1:45–2:30 PM Paper Presentation Topic: “One Health Pandemic Prevention and Mitigation: The Role of FDA” Margaret Foster Riley, University of Virginia, and Member, FDLI Board of Directors Discussants: Bernadette Dunham, Milken Institute School of Public Health, George Washington University and Advisor to the FDA One Health Initiative, Center for Veterinary Medicine, FDA Capt. Brianna Skinner, Office of the Commissioner, Office of Counterterrorism and Emerging Threats, FDA 2:30–2:45 PM Break 2:45–4:15 PM Paper Presentations Topic: “Federal Law’s Protective Quilt: Understanding the Statutory Regimes for Personal Protective Equipment (PPE) and Recommending an Additional Piece” John F. Johnson III, Shook, Hardy & Bacon LLP Topic: “Regulatory Reactivity: FDA and the Response to COVID-19” Yaniv Heled, Georgia State College of Law Ana Santos Rutschman, St. Louis University School of Law Liza Vertinsky, Emory University School of Law Discussants: Lewis Grossman, American University Alan G. Minsk, Arnall Golden Gregory LLP Carolina M. Wirth, Arnall Golden Gregory LLP © 2020 by the Food and Drug Law Institute (FDLI) *Author is not presenting at the FDLJ 2020 Symposium 3 Food and Drug Law Journal 2020 Symposium November 12-13, 2020 ANNEKE BARAN ALTIERI is an associate at Hogan Lovells US LLP where she provides practical legal and policy solutions to clients at all levels of the food supply chain. She is committed to helping clients navigate the complex state and federal regulatory landscape, without sacrificing business innovation. Anneke advises clients on US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) labeling and advertising requirements, food safety issues, and enforcement actions. Anneke also has experience counseling clients in the consumer product, pharmaceutical, and health care industries and maintains an active pro bono practice. Drawing on previous regulatory experience with the Department of Homeland Security, Anneke understands the nuanced intersection of government and industry. Before arriving at Hogan Lovells, Anneke graduated from the University of Virginia School of Law, where she was a Fellow for the Legal Research and Writing Program and served on the editorial board of the Virginia Law and Business Review. KALAH AUCHINCLOSS is Senior Vice President, Regulatory Compliance and Deputy General Counsel at Greenleaf Health, LLC. She has more than a decade of food and drug legal, policy, and regulatory experience at FDA, on Capitol Hill, and in the private sector. Ms. Auchincloss spent six years at FDA, most recently as Deputy Chief of Staff for two FDA Commissioners: Dr. Robert Califf and Dr. Scott Gottlieb. As Deputy Chief of Staff, she worked with senior FDA leadership to manage crises, develop policy decisions, implement communications strategies, and liaise with the Department of Health and Human Services, the White House, and other agencies. Ms. Auchincloss was also a primary point of contact in the immediate Office of the Commissioner for the six FDA Centers and other components of the Commissioner’s Office. She has also served in FDA’s Center for Drug Evaluation and Research (CDER) as a regulatory counsel in the Office of Regulatory Policy, and as Director of CDER’s Office of Unapproved Drugs and Labeling Compliance in the Office of Compliance, leading a team of more than 50 staff working on pharmacy compounding, unapproved drugs, over-the- counter drugs, and other enforcement issues. Before joining FDA, Ms. Auchincloss was an associate at the law firm Foley Hoag LLP, in the firm’s health care practice group. She holds a BA with honors from Williams College, a JD with honors from Georgetown University Law Center, and an MPH from Harvard University. MICAH BERMAN is an associate professor of public health and law at The Ohio State University’s College of Public Health and Michael E. Moritz College of Law. He teaches courses on public health law, health care law, and tobacco regulation, and he is a co-author of a The New Public Health Law: A Transdisciplinary Approach to Practice and Advocacy (Oxford University Press & APHA Press, 2018). His current research, funded by the National Cancer Institute, seeks to inform the FDA’s regulation of tobacco products. Before joining Ohio State’s faculty in 2013, Professor Berman directed policy centers that provided legal and policy support to state and local health departments in Ohio, New York, and Vermont. He has also served as a senior advisor to the FDA’s Center for Tobacco Products and as a trial attorney with the US Department of Justice. He received his JD with distinction from Stanford Law School and his BA in Public Policy from Brandeis University. LAURIE BEYRANEVAND is Senior Faculty Fellow of Food Law and Policy at the Center for Agriculture and Food Systems, and a professor of law at Vermont Law School. Prior to joining the faculty at Vermont Law School, Laurie was a Staff Attorney at Vermont Legal Aid where she represented adults and children in individual cases and class action litigation advocating for access to health care, education equality, and civil rights. Laurie has published a number of scholarly articles and book chapters that focused on the connections between human health and food systems. Her work has been cited in petitions to major federal agencies, books, blogs, and articles, and she has been quoted in Politico, Mother Jones, the Christian Science Monitor, Climate Wire, the Washington Post, and E & E Greenwire, among others. She is an appointed member of the Food and Drug Law Institute and Georgetown Law School’s Food and Drug Law Journal Editorial Advisory Board, a founding member of the Academy of Food Law and Policy, and the Chair of the Agriculture and Food Law Section of the American Association of Law Schools. NATHAN A. BROWN is a partner in the Health Care and Life Sciences practice at Akin Gump. He has worked extensively in the FDA regulatory and compliance field and is sought after for his understanding and insights into the regulation and marketing of innovative medical technologies.