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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 1ADrugs 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 1BFood 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 1CMedical 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 2ADrugs 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 2BMedical 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 2COther 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 3AMedical 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 3BBiological 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 3CBeyond 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

Interact with us on social media using #FDAConf18

2018-10-22T09:46:14+00:00