Symposium Materials

Presentation slides will be added as speakers make them available

9:25 AM | Medical Products: Exploring the Public Health Implications of Off-Label Communications

1:30 PM | Food Labeling and Consumer Perceptions 

3:00 PM | Tobacco Products: Should FDA Try to Move Smokers to E-Cigarettes or Other Less-Harmful Tobacco-Nicotine Products and, if so, How?

This year’s Food and Drug Law Journal Symposium explores FDA’s role as a public health regulator that directly influences the health choices made by the general public.  Panels of scholars and practitioners will analyze the breadth of FDA’s impact through its regulatory authority, which goes beyond establishing parameters for product safety and efficacy for market entry, to affect choices made by consumers, patients, and health providers.

Authors will present original scholarship on these topics:

  • Tobacco: Whether and how the agency should encourage smokers to move to vaping;
  • Food: How labeling is perceived and acted upon by consumers;
  • Medical Products
    • How can the agency address the opioid epidemic?
    • What are the public health consequences of off-label communications?

Register 

Registration for students and FDLI members is complimentary but advanced registration is required (use link below).

Georgetown University-affiliated faculty and staff are asked to RSVP by email.

Industry & Firms

$FREE for members
  • $199 for nonmembers

Non-Profit

$FREE for members
  • $49 for nonmembers

Government

$FREE for members
  • $49 for nonmembers

Academic

$FREE for members
  • $49 for nonmembers

Student

$FREE
  • (must provide transcripts)

Agenda

subject to change

8:45 AM 
Registration and Continental Breakfast

9:15–9:25 AM
FDLI and Georgetown University Welcome                                      

9:25–10:35 AM
Medical Products: Exploring the Public Health Implications of Off-Label Communications

Authors: 
Jeffrey Chasnow, SVP & Associate General Counsel, Pfizer
Geoffrey Levitt, Chief Regulatory Counsel, Pfizer

Discussants:
Allison Zieve, Director, Public Citizen Litigation Group, Immediate Past Chair, FDLI Board of Directors
Kellie B. Combs, Partner, Ropes & Gray LLP

Moderator:
Amy Comstock Rick, President & CEO, FDLI

10:35 – 10:45 am
Coffee and Networking Break

10:45 AM –12:00 PM                
Medical Products: FDA and Opioid Use

Author: 
Patricia Zettler, Associate Professor, Georgia State University College of Law

(Co-Authors):
Aaron Kesselheim, Director, Program on Regulation, Therapeutics and Law, Harvard Medical School
Margaret Foster Riley, Professor of Law, University of Virginia School of Law

Discussants:
John A. Gilbert, Jr., Director, Hyman, Phelps & McNamara, PC
Frederick (Rick) R. Ball, Partner, Duane Morris LLP

12:00–1:30 PM
Luncheon Keynote
Peter Barton Hutt, Harvard Law School and Senior Counsel, Covington & Burling LLP

Introduced by Joseph A. Page, Professor Emeritus, Georgetown University Law Center

1:30–2:45 PM              
Food Labeling and Consumer Perceptions

Authors: 
Michael T. Roberts, Executive Director, Resnick Program for Food Law and Policy, UCLA Law
Efthimios Parasidis, Associate Professor of Law and Public Health, Moritz College of Law, Ohio State University   

Discussant:
Steve Armstrong, EAS Consulting Group, and Member, FDLI Board of Directors   

Moderator:
Deepti A. Kulkarni, Attorney, Sidley Austin LLP                                                   

2:45-3:00 PM
Coffee and Networking Break                       

3:00-4:30 PM           
Tobacco Products: Should FDA Try to Move Smokers to E-Cigarettes or Other Less-Harmful Tobacco-Nicotine Products and, if so, How?

Moderator/Convener: 
Eric Lindblom, Director, Tobacco Control and Food & Drug Law, O’Neill Institute for Global and National Health Law, Georgetown University

Respondents: 
Jeffrey Weiss, General Counsel & Senior Vice President of Government Affairs, NJOY, LLC
Kenneth E. Warner, University Professor of Public Health, Professor, Health Management & Policy, School of Public Health, University of Michigan
Matthew L. Myers, President, Campaign for Tobacco-Free Kids
Valerie Briggs Solomon, Managing Counsel, R&D and Regulatory, RAI Services Company

4:30-5:30 PM
Networking Reception

Continuing Legal Education

FDLI applies for CLE credits in Ohio, Pennsylvania, 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.

Approved:
Virginia – 5.0 CLE credit hours

Location and Overnight Accommodations

Location

Jones Day
300 New Jersey Avenue, NW
Washington, DC 20001

Overnight Accommodations

The following hotels are within walking distance of the meeting location:

The Liaison Capitol Hill, 415 New Jersey Ave NW
Hyatt Regency Washington on Capitol Hill, 400 New Jersey Ave NW
Washington Court Hotel, 525 New Jersey Ave NW
Kimpton George Hotel, 15 E St NW

Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.