2020 Conference Update

FDLI remains committed to providing high-quality educational programs while keeping our members and event attendees safe during the current pandemic. With this in mind,  we are excited to announce that the Food and Drug Law Journal 2020 Symposium will be a completely virtual event. Please know we are actively exploring options to ensure an engaging and enjoyable experience with ample opportunities to connect with your peers.

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

The Food and Drug Law Institute solicits legal scholarship on the federal response to the COVID-19 pandemic and how past and present lessons provide guidance for the future.

The Past: How do the polio, swine flu, SARS, and other past health and other crises aid in our understanding of how FDA and other federal agencies should navigate pandemics?

The Present and Future: What are the immediate lessons of the federal response to the COVID-19 pandemic and how can they help inform future action? Would legislative or regulatory changes help FDA and other agencies respond to future pandemics?

The Food and Drug Law Journal 2020 Symposium encourages thoughtful scholarship on such issues as disease monitoring, development of diagnostics, assessment and storage of protective gear, vaccine development, “social distancing” as a future remedy, emergency regulatory waivers and flexibilities, and other topics. Like the Journal, this Symposium will focus on FDA-regulated products, but submissions can focus on regulators other than FDA.

 The Food and Drug Law Journal is the publication sponsor for this Symposium, reserving a right of first refusal to offer publication of submitted papers that conform to the requirements set forth below.

 

The Food and Drug Law Journal (FDLJ) will have a right of first refusal to publish final papers accepted for the FDLJ 2020 Symposium, subject to their editorial review process. All final papers should be double-spaced and in Times New Roman font. FDLJ requires footnotes that conform with The Bluebook: A Uniform System of Citation. Additional author guidelines are available online here. Questions regarding submission requirements may be directed to [email protected].

Call for Abstracts

The Call for Abstracts closed on June 15, 2020. Draft articles from accepted authors must be submitted by October 23, 2020. Thank you to everyone who submitted a paper!

Please contact Paige Samson with any questions.

Agenda

Thursday, November 12

12:00–12:15 PM
Welcome Remarks

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

“History, Legislative Innovation, and Future Pandemics”

Daniel A. Kracov, Arnold & Porter and Vice Chair, FDLI Board of Directors

“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

“The American Pharmaceutical Supply Chain: Will COVID-19 Drive Manufacturing Back Home?”

Gregory H. Levine, Jenna McCarthy*Beth P. Weinman, Ropes & Gray LLP, and Grant Sims*, NYU Stern School of Business

Moderator:  Marian J. Lee, Gibson, Dunn & Crutcher LLP
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

“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

“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

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

“How We Got Here: FDA Emergency Use Authorization from 9/11 to COVID-19”

Jonathan Iwry, Havard Law School

“Assessing COVID-19 Emergency Use Authorizations”

Efthimios Parasidis, Patricia J. Zettler*, and Micah Berman*, The Ohio State University

Moderator:  Joseph Page, Georgetown University
DiscussantNathan A. Brown, Akin Gump Strauss Hauer & Feld LLP

 

1:30–1:45 PM
Break

1:45–2:30 PM
Paper Presentation

“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

“Updating the Federal Approach to Regulating Personal Protective Equipment

John F. Johnson III, Shook, Hardy & Bacon LLP

“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

 

 

 

*Author is not presenting at the FDLJ Symposium

Sponsorship Opportunities 

Sponsorship opportunities are available. Please let us know if you would like more information.

Planning Committee

Chair

James T. O’Reilly, University of Cincinnati

Members

Nigel Barrella, The Good Food Institute 
Laurie J. Beyranevand, Vermont Law School
Jennifer Black, OC, FDA
Marie Boyd, University of South Carolina
Nathan Brown, Akin Gump Strauss Hauer & Feld LLP
Bridget C.E. Dooling, George Washington University
Carl Fischer, Becton Dickinson (BD)
Lewis Grossman, American University
Peter Barton Hutt, Covington & Burling LLP
John Johnson III, Shook, Hardy & Bacon LLP
Alan C. Katz, toXcel, LLC
Dinesh Kumar, OC, FDA
Marian J. Lee, Gibson Dunn & Crutcher LLP
Priya Malavika Mannan, Novartis Pharmaceuticals Corporation
J. R. McNair, Winston & Strawn LLP
Alan G. Minsk, Arnall Golden Gregory LLP
Anne Marie Murphy, Consumer Healthcare Products Association (CHPA)
Nicole Negowetti, Harvard Law School
Joseph A. Page (Academic Advisor), Georgetown University
Sung Park, Reed Smith LLP
Jessica Ringel, King & Spalding LLP
Marc J. Scheineson, Alston & Bird LLP
Shy Shorer, National Institutes of Health
Anna Sims, OC, FDA
Eric Solowey, Parexel International Corporation
Andrew Wasson, Haug Partners LLP
Emily Wright, Pfizer, Inc.
Patti Zettler, The Ohio State University

Continuing Legal Education

FDLI applies for CLE credits in Ohio and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.