In collaboration with the American University Washington College of Law, the Food and Drug Law Institute is sponsoring this comprehensive conference examining the past, present, and future of the Food and Drug Administration, featuring FDA Commissioners and Chief Counsels spanning five decades. Join leading practitioners, researchers, and policymakers from across the nation for the full-day event.

The event is complimentary for FDLI members, with CLE credits available at a fee.

Speakers

 

Robert M. Califf, MD

Professor of Medicine, Duke University; Former Commissioner of the U.S. Food and Drug Administration

 

Andrew C. von Eschenbach, MD

President, Samaritan Health Initiatives

 

Margaret Hamburg, MD

President, American Association for the Advancement of Science  Foreign Secretary, National Academy of Medicine; Former Commissioner of the  U.S. Food and Drug Administration

 

David Kessler, MD, JD

Professor, University of California San Francisco; Former Commissioner of the U.S. Food and Drug Administration

Agenda

subject to change

Friday, October 19

8:30 – 9:30 AM
Registration and Continental Breakfast | Founders Lobby, Yuma Building, Terrace Level

9:30 – 10:45 AM
Concurrent Session 1

Session 1A Drugs I
  Moderated by Grail Sipes, JD, Deputy Center Director for Regulatory Policy, CDER, FDA
   
  The History and Political Economy of the Hatch-Waxman Amendments
  Erika Lietzan, JD, MA Associate Professor of Law, University of Missouri School of Law
  Commentary by Kurt Karst, JD (AUWCL), Director, Hyman, Phelps & McNamara, P.C.
   
  The More Things Change: Improvement Patents, Drug Modifications, and the FDA
  Dmitry Karshtedt, JD, PhD, MA, Associate Professor of Law, George Washington University Law School
  Commentary by James N. Czaban, JD, Partner, Chair, FDA Practice Group, DLA Piper

 

Session 1B Food and Animal Products
  Moderated by Stuart Pape, JD, Shareholder and Practice Chair, Polsinelli
   
  Retooling American Foodralism
  Laurie Beyranevand, JD, Associate Dean for Academic Affairs, Director, Center for Agriculture and Food Systems, Professor of Law, Vermont Law School
  Diana Winters, JD, PhD, MA, Assistant Director of Scholarship, Resnick Center for Food Law and Policy, University of California Los Angeles School of Law
  Commentary by Jeannie Perron, DVM, JD, Partner, Covington & Burling LLP
   
  Administrative Guidance and Genetically Modified Food
  Joanna Sax, JD, PhD, E. Donald Shapiro Professor of Law, California Western School of Law
  (Coauthor: Edward L. Rubin, JD, MA, University Professor of Law and Political Science, Vanderbilt University Law School)
  Commentary by Sarah Roller, JD, RD, MPH, Partner, Chair, Food and Drug Law Practice, Kelley Drye & Warren LLP

 

Session 1C Medical Products: Cross-Cutting Issues I
  Moderated by Elizabeth Jungman, JD, MPH, Director of Public Health Programs, Pew Charitable Trusts and Member, FDLI Board of Directors
   
  Can the Food Drug and Cosmetic Act Survive the 21st Century?
  Ralph F. Hall, JD, Professor of Practice, University of Minnesota Law School
  Commentary by Daniel Kracov, JD, Partner and Co-chair, Live Sciences and Healthcare Regulatory Practice, Arnold & Porter LLP and Adjunct Professor of Law, American University Washington College of Law and Member, FDLI Board of Directors
   
  Regulating Intermediate Technologies
  Rachel E. Sachs, JD, MPH, Associate Professor of Law, Washington University Law School
  Commentary by Gail H. Javitt, JD, MPH, Member of the Firm, Epstein Becker Green

 

10:45 – 11:15 AM
Break | Founders Lobby, Yuma Building, Terrace Level

11:15 – 11:45 AM
Welcome Remarks | Claudio Grossman Hall, Yuma Building, Terrace Level
Lewis Grossman, JD, PhD, Professor of Law, American University Washington College of Law
Amy Comstock Rick, JD, President and CEO, Food and Drug Law Institute
Sylvia Mathews Burwell, President, American University, former U.S. Secretary of Health and Human Services

11:45 – 12:45 AM
Plenary Session 1: A Discussion with Former FDA Commissioners | Claudio Grossman Hall, Yuma Building, Terrace Level
Hosted by Lewis Grossman, JD, PhD, Professor of Law, American University Washington College of Law
Robert Califf, MD, Professor of Medicine, Duke University
Margaret Hamburg, MD, President, American Association for the Advancement of Science and Foreign Secretary of the National Academy of Medicine
David Kessler, MD, JD, Professor, University of California San Francisco
Andrew C. von Eschenbach, MD, President, Samaritan Health Initiatives, Inc.

11:45 – 1:15 PM
Lunch Buffet | Founders Lobby, Yuma Building, Terrace Level

1:15 – 2:15 PM
Plenary Session 2: A Discussion with Former FDA Chief Counsels | Claudio Grossman Hall, Yuma Building, Terrace Level
Hosted by I. Glenn Cohen, JD, James A. Attwood and Leslie Williams Professor of Law, Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics Harvard Law School
Richard Cooper, JD, MA, Senior Counsel, Williams & Connolly, LLP
Peter Barton Hutt, LLB, LLM, Senior Counsel, Covington & Burling LLP
Gerald Masoudi, JD, Chief Legal Officer, JUUL Labs, Inc.
Daniel Troy, JD, Senior Vice President and General Counsel, GlaxoSmithKline PLC

2:15 – 2:30 PM
Break | Founders Lobby, Yuma Building, Terrace Level

2:30 – 3:45 PM
Concurrent Session 2

Session 2A Drugs II
  Moderated by TBA
  Reversal of Fortune: Moving Pharmaceuticals from Over-the-Counter to Prescription Status?
  Lars Noah, JD, Professor of Law, Stephen C. O’Connell Chair, University Term Professor, University of Florida Levin College of Law
  Commentary by David C. Spangler, JD, Senior Vice President, Policy, and General Counsel and Secretary, Consumer Healthcare Products Association
   
  On Drugs: Renovating Preemption
  Elizabeth Y. McCuskey, JD, Professor of Law, University of Toledo Law School
  Commentary by Brian Wolfman, JD, Associate Professor of Law, Director, Appellate Court Immersion Clinic, Georgetown University Law Center

 

Session 2B Medical Products: Cross-Cutting Issues II
  Moderated by Theresa Mullin, PhD, Associate Director for Strategic Initiatives, CDER, FDA
   
  21st Century Citizen Pharma: The FDA & Patient Focused Drug Development
  Jordan Paradise, JD, Georgia Reithal Professor of Law, Loyola University Chicago School of Law
  Commentary by Marc M. Boutin, JD, Chief Executive Officer, National Health Council
   
  Non-Therapeutic Uses and the FDA
  Patricia J. Zettler, JD, Associate Professor, Georgia State University College of Law
  Commentary by Geoffrey Levitt, JD, Senior Vice President and Associate General Counsel for Regulatory, Environmental and Global Supply, Pfizer, Inc.

 

Session 2C Other FDA Product Areas: Tobacco and Cosmetics
  Moderated by Linda Katz, MD, MPH, Director, Office of Cosmetics and Colors, Acting Chief Medical Officer, Center for Food Safety and Applied Nutrition, FDA
   
  Gender & the Inadequate Regulation of Cosmetics
  Marie Boyd, JD, Assistant Professor of Law, University of South Carolina School of Law
  Commentary by Alexandra Gerber, JD, Vice President, Assistant General Counsel, Revlon, Inc.
   
  Is the End of Smoking in Sight?: Tobacco Control in the Trump Years and Beyond
  Micah L. Berman, JD, Associate Professor, Ohio State University, Moritz College of Law and College of Public Health
  Commentary by Azim Chowdhury, JD, MBA, Partner, Keller and Heckman LLP

 

3:45 – 4:00 PM
Break | Founders Lobby, Yuma Building, Terrace Level

4:00 – 5:15 PM
Concurrent Session 3

Session 3A Medical Devices
  Moderated by Bakul Patel, MBA, MSc, Associate Center Director for Digital Health, CDRH, FDA
   
  FDA’s Role in Governance of Black-Box Medicine
  W. Nicholson Price II, JD, PhD, Assistant Professor of Law, University of Michigan Law School
  Commentary by Jeffrey N. Gibbs, JD, Director, Hyman, Phelps & McNamara, P.C. and Chair, FDLI Board of Directors
   
  Digital Health and Regulatory Experimentation at the FDA
  Nathan Cortez, JD, Associate Dean for Research, Gerald J. Ford Research Fellow, Adelfa Botello Callejo Endowed Professor of Law in Leadership and Latino Studies, Southern Methodist University Dedman School of Law
  Commentary by Wade Ackerman, JD, Partner, Covington & Burling LLP

 

Session 3B Biological Products
  Moderated by Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, FDA
   
  Follow-On Biologics Are Set Up to Fail
  Yaniv Heled, LLB, LLM, JSD, Associate Professor of Law, Co-Director, Center for Intellectual Property Law, Georgia State University College of Law
  Commentary by Michael Werner, JD, Partner, Co-Leader, Healthcare & Life Sciences Team, Holland & Knight LLP
   
  Improving Life Sciences Regulation: Solutions to the Current Impasse
  Myrisha S. Lewis, JD, Assistant Professor of Law, Howard University School of Law
  Commentary by Chad Landmon, JD, Partner, Chair, Intellectual Property and FDA Practice Groups, Axinn, Veltrop & Harkrider LLP

 

Session 3C Beyond Traditional Drug Regulation
  Moderated by Henry T. Greely, JD, Director, Center for Law and the Biosciences; Professor (by courtesy) of Genetics, Stanford School of Medicine; Chair, Steering Committee of the Center for Biomedical Ethics; and Director, Stanford Program in Neuroscience and Society
   
  Cannabis for Medical Use: FDA and DEA Regulation in the Hall of Mirrors
  Rebecca S. Eisenberg, JD, Robert and Barbara Luciano Professor of Law, University of Michigan Law School
  (Coauthor: Deborah B. Leiderman, MD, MA, Principal, CNS Drug Consulting LLC)
  Commentary by D. Kyle Sampson, JD, Partner, King & Spalding LLP
   
  Drugs’ Other Side-Effects
  Craig Konnoth, JD, MPhil, Associate Professor of Law, University of Colorado Boulder Law School
  Commentary by Peter Pitts, President, Center for Medicine in the Public Interest

 

5:15 – 6:45 PM
Reception Honoring AUWCL Food and Drug Law Alumni | Claudio Grossman Hall, Yuma Building, Terrace Level
All conference attendees are welcome
Remarks by Mitch Zeller, JD, AUWCL class of 1982, Director, Center for Tobacco Products, FDA

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