Food and Drug Law Journal Symposium
Going Viral: Safeguarding Public Health in the Modern Era
One of the fundamental responsibilities of government is protecting the public health. While food and drug law-related issues have faced public pressure since the inception of regulation, the speed and breadth of information sharing has transformed the role. Today, a single scientific study, news article, or individuals on the Internet can start a movement and quickly sway public opinion—even if it’s spreading misinformation. Intense pressure from the public may prompt legislatures or administrative agencies to craft laws, rules, regulations, policies, or casual Agency actions to address these concerns. This academic symposium will explore the public health impacts when these actions are based not on exhaustive scientific studies, but on public pressure. Examples include social media influencers, developing innovative devices, stem cells, genetically modified organisms, food labeling, and more.
Call for Abstracts
The Call for Abstracts closed on August 9, 2019. Accepted articles will be notified by August 16, and draft articles must be submitted by November 1.
Please contact Paige Samson with any questions.
subject to change
Registration and Continental Breakfast
Welcome and Announcements
Paige Samson, Director, Innovative Programs and Publications, FDLI
“FDA Regulation of Adipose Stem Cell Therapies: Separating Fat from Fiction”
Mary Ann Chirba, Professor, Boston College Law School
“Public Perception and Policy Development in Consent Standards for Human Research—How Competing Views on Public Goods and Private Interests Shape Data Sharing, Big Data Research, and Other Activities Using Human Data and Materials”
Valerie Bonham, Counsel, Ropes & Gray LLP
David Peloquin, Associate, Ropes & Gray LLP
Discussant: Kalah Auchincloss, Senior Vice President, Regulatory Compliance and Deputy General Counsel, Greenleaf Health
Moderator: Barbara Binzak Blumenfeld, Shareholder, Buchanan Ingersoll & Rooney PC
“With Great Influence Comes Great Responsibility”
Tamany Vinson Bentz, Partner, DLA Piper LLP (US)
Carolina Veltri, Associate, DLA Piper LLP (US)
Discussant: Beth P. Weinman, Counsel, Ropes & Gray LLP
Moderator: Carl Fischer, Senior Director, WW Regulatory & Quality Strategy, Becton Dickinson (BD)
Networking and Coffee Break
11:30 AM–12:45 PM
“A Shifting Regulatory Framework for Digital Health: The Impact of Silicon Valley on the FDA’s Mission to Promote and Protect the Public Health”
M. Jason Brooke, General Counsel and Vice President of Regulatory & Quality, AmalgamRX
“Development and Regulation of Innovations: In the Current State of Facts vs. Public Opinions, the Truth Does Not Always Prevail
Sangeeta Abraham, Consultant, Managing Scientist, Exponent, Inc.
Nicholas Benetatos, Manager, Exponent, Inc.
Michael Frohbergh, Senior Associate, Exponent, Inc.
Kevin Ong, Principal Engineer, Exponent, Inc.
Discussant: Nathan Brown, Partner, Akin Gump Strauss Hauer & Feld LLP
Moderator: Karen C. Corallo, Of Counsel, Skadden, Arps, Slate, Meagher & Flom LLP
“Modernizing Food Labeling: The Narratives of Food Innovation and Deciphering Mixed Messages”
Nicole Negowetti, Lecturer on Law and Clinical Instructor, Harvard Law School
“’NonGMO Labels’—Absence Claims—The Law, Congressional Intent, and FDA Policy”
L. Val Giddings, Senior Fellow, Information Technology & Innovation Foundation
Discussant: Nigel Barrella, Attorney, Barrella Law PLLC
Moderator: Laurie Beyranevand, Professor of Law and Director, Center for Agriculture and Food Systems, Vermont Law School
Networking and Coffee Break
“Strengthening the Information Quality Act to Improve Federally Disseminated Public Health Information”
Daren Bakst, Senior Research Fellow in Agricultural Policy, Roe Institute for Economic Policy Studies, The Heritage Foundation
Discussant: Lewis Grossman, Professor of Law, American University
Moderator: James O’Reilly, Professor of Law, University of Cincinnati
Symposium Adjournment and Closing Remarks
Anthony J. Anscombe, Steptoe & Johnson LLP
Nigel Barrella, Law Office of Nigel Barrella
Kenita Barrow, Otsuka America Pharmaceutical, Inc.
Laurie J. Beyranevand, Vermont Law School
Barbara A. Binzak Blumenfeld, Buchanan Ingersoll & Rooney PC (Chair)
Marie Boyd, University of South Carolina
Nathan Brown, Akin Gump Strauss Hauer & Feld LLP
Catherine A. Clements, Eli Lilly and Company
Carl Fischer, Becton Dickinson
Ralph Hall, University of Minnesota
Peter Barton Hutt, Covington & Burling LLP
Erica Michele Jackson, K&L Gates LLP
William M. Janssen, Charleston School of Law
John Johnson, FDAImports.com, LLC/ Benjamin L. England & Associates LLC
Alan C. Katz, toXcel, LLC
Sari Bourne Kaplan, Genentech, Inc.
Sara Wexler Koblitz, Hyman, Phelps & McNamara, PC
Hilary Lewis, Morgan, Lewis & Bockius LLP
Priya Malavika Mannan, Novartis Pharmaceuticals Corporation
Alexandra Marzelli, FDA – OC
J.R. McNair, Winston & Strawn LLP
Alan Minsk, Arnall Golden Gregory, LLP
Nicole E. Negowetti, Harvard Law School
James T. O’Reilly, University of Cincinnati
Bruce Patsner, University of Houston
Sandra Retzky, FDA – CTP
Jessica Ringel, King & Spalding LLP
Melissa B. Runsten, Debevoise & Plimpton, LLP
Marc Scheineson, Alston & Bird LLP
Jodi Schipper, FDA – CDER
Shy Shorer, National Institutes of Health
David C. Spangler, Consumer Healthcare Products Association (CHPA)
Andrew Wasson, Haug Partners LLP
Emily Wright, Pfizer, Inc.
Lowell Zeta, Hogan Lovells US LLP
Patricia Zettler, The Ohio State University
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.
Pennsylvania: approved for 5.0 credit hours.
Location and Overnight Accommodations
Akin Gump Strauss Hauer & Feld LLP
2001 K St NW
Washington, DC 20006
Accommodation options will be announced soon.
Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.