Why Attend

Preliminary Agenda

All times listed are Eastern Time

To attend sessions in-person, you are required to be fully vaccinated

Location & CLE

Tuesday, June 14

Amy Comstock Rick, President & CEO, FDLI
Vernessa T. Pollard, Partner, McDermott Will & Emery and Co-Chair, 2022 FDLI Annual Conference

Robert Califf, Commissioner of Food and Drugs, FDA
Introduced by Daniel A. Kracov, Partner, Arnold & Porter LLP and Chair, FDLI Board of Directors

 

Mark J. Raza, Chief Counsel, FDA 

Holly Fernandez Lynch, John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics, University of Pennsylvania
Stephen Ostroff, Public Health and Regulatory Consultant, S. Ostroff Consulting and Medical Science Trustee, USP
Lowell J. Schiller, Chief Legal and Regulatory Officer, Aetion, Inc.
Joshua M. Sharfstein, Vice Dean for Public Health Practice and Community Engagement, Johns Hopkins Bloomberg School of Public Health
Moderated by Amy Comstock Rick, President & CEO, FDLI

FDLI Distinguished Service and Leadership Award
The FDLI Distinguished Service and Leadership Award, established in 1993, recognizes individuals who have made notable contributions to the food and drug law community through their leadership.

Award Recipients:
Andrea Chamblee, Senior Counsel, Wilson Sonsini
Daniel R. Dwyer, Partner, Kleinfeld, Kaplan & Becker, LLP
Jarilyn Dupont, Director of Regulatory Policy, Office of the Commissioner, FDA
Presented by Amy Comstock Rick, President & CEO, FDLI and
Daniel A. Kracov, Partner, Arnold & Porter LLP and Chair, FDLI Board of Directors

Judy A. McMeekin, Associate Commissioner for Regulatory Affairs, Office of Regulatory Affairs, FDA

2:05–3:05 PM | Concurrent Breakout Sessions 1

During this session, FDA leadership will address the top issues CVM is facing as well as priorities and goals for the coming year.

Steven M. Solomon, Director, Center for Veterinary Medicine, FDA
Moderated by Keith A. Matthews, Of Counsel, Wiley LLP

Despite there being support in statutory provisions and FDA guidance providing recommendations for use of the accelerated approval pathway to facilitate more efficient development of innovative drugs for serious conditions, there seems to be a lack of clarity on appropriate use of the pathway, especially in light of recent high-profile approvals and withdrawals and the CMS decision to narrowly cover an FDA-approved drug. This panel will discuss the current regulatory process and whether changes are needed to reinforce the existing areas where accelerated approval has been successful, and to promote the transparent and accountable use of accelerated approval going forward.

Jeff Allen, Executive Director, Friends of Cancer Research
David V. Ceryak, Senior Director, Assistant General Counsel, Regulatory Legal Team, Eli Lilly and Company
Marc Theoret, Deputy Director, Oncology Center of Excellence, FDA & Supervisory Associate Director (Acting), Office of Oncologic Diseases, CDER, FDA
Moderated by William B. Schultz, Partner, Zuckerman Spaeder LLP

FDA has begun to approve interchangeable biosimilars, which raise a host of complex and challenging legal issues relating to exclusivity, labeling, automatic substitution, and the need for switching studies. During this session, speakers will discuss what can be learned from the first interchangeable approvals and what it tells us about FDA’s interchangeability framework. Speakers will also address what’s next, including what the competitive landscape for biologics looks like, how the statutory standard regarding “any given patient” may play out, and whether applicants will be able to use real world evidence to support interchangeable licensure.

Brian Burgess, Partner, Goodwin Procter LLP
Brian C. Stone, Global Regulatory Counsel, Viatris, Inc.
Eva Temkin, Partner, King & Spalding LLP

Al/ML-based technologies have the potential to transform healthcare through their unique ability to learn from real-world feedback and adapt based on these learnings. However, the data that is used to learn may drive inherent biases. What can FDA and companies to do ensure that AI/ML-enabled products do not reproduce or amplify existing inequalities? This session will explore how biases from collection can degrade AI/ML algorithm performance and what tools FDA and companies can use to help combat bias.

Matthew Diamond, Chief Medical Officer, Digital Health Center of Excellence, CDRH, FDA
Jonelle Saunders, Associate Product Counsel, Google Health
Bradley Merrill Thompson, Partner, Epstein Becker & Green, PC
Moderated by Vernessa T. Pollard, Partner, McDermott Will & Emery and Co-Chair, 2022 FDLI Annual Conference

More than 300 class action lawsuits were filed against the food and beverage industry last year. What is causing the increase in cases, and what are the predominant areas being litigated? This panel will delve into some of the key focus areas of recent class action cases, including front-of pack claims, ingredient representation and origin, ‘reasonable consumer’ defenses, sugar-related litigation, and scrutiny of class action settlements.

David Biderman, Partner, Perkins Coie LLP
Keri E. Borders, Partner, Mayer Brown LLP
Christopher Van Gundy, Partner, Sheppard Mullin Richter & Hampton LLP
Maia Kats, Managing Attorney, Just Food Law PLLC

Since enactment of the “Deeming Rule,” Electronic Nicotine Delivery System (ENDS) products have been regulated as “tobacco products,” subject to the requirements of the Tobacco Control Act. Thus, in order to stay on the market, they were required to submit a Premarket Tobacco Application (PMTA) by September 9, 2021 and receive a marketing order from the FDA. The Agency did not anticipate the nearly 6 million applications it received and ended up issuing Marketing Denial Orders arguably not in accordance with the rule and guidance it set forth outlining PMTA requirements. As a result, multiple companies brought legal action against the FDA for acting in an arbitrary and capricious manner. This panel will explore key cases, including any active litigation challenging FDA denial of PMTAs.

Micah L. Berman, Associate Professor of Public Health and Law, The Ohio State University
Eric Heyer, Partner, Thomson Hine LLP
Moderated by Barry Schaevitz, Partner, Fox Rothschild LLP

3:15–4:15 PM | Concurrent Breakout Sessions 2

During this session, FDA leadership will address the top issues CDER is facing as well as priorities and goals for the coming year.

Patrizia Cavazzoni, Director, Center for Drug Evaluation and Research, FDA 
Moderated by Patti Zettler, Associate Professor of Law, The Ohio State University and Member, FDLI Board of Directors

Gene therapies have provided great promise for medical advances, and viral vectors have also contributed to the pandemic response. But with these advances have come significant challenges, from clinical trial holds and application delays, to commercialization and manufacturing obstacles. In addition, FDA has raised safety questions about the inherent risks of viral vectors and higher doses. This session will address the legal and regulatory concerns for these new therapies, provide and how to best overcome these challenges, and discuss the new resources for cell and gene therapies that are expected from PDUFA VII.

Wilson W. Bryan, Director, office of Tissues and Advanced Therapies, CBER, FDA
Mantej (Nimi) Chhina, Senior Director, Global R&D and Regulatory Policy, BioMarin Pharmaceutical, Inc.
Nathan C. Sheers, Partner, Paul Hastings
Moderated by Kalah Auchincloss, Executive Vice President and Deputy General Counsel, Greenleaf Health, Inc.

The frequent exchange and transmission of medical device-related health information, as well as recent cybersecurity incidents that have impacted patient care, means that cybersecurity must be an integral part of device safety and effectiveness. In April 2022, the FDA released a draft guidance on quality system considerations and premarket submissions to address how companies can design for security and manage cybersecurity risks. Speakers will discuss implementation of the guidance and provide insight into to identifying vulnerabilities, responding to incidents, and placing safeguards to reduce security breaches when using and servicing medical devices.

Dana-Megan Rossi, Director of Information Security, WW Regional Cybersecurity Officers, BD
Zach Rothstein, Senior Vice President, Technology & Regulatory Affairs, AdvaMed
Suzanne Schwartz, Director, Office of Strategic Partnerships and Technology Innovation, CDRH, FDA
Moderated by Marian J. Lee, Partner, Gibson, Dunn & Crutcher LLP

What’s new in the world of dietary supplements? This session will address the issues front-and-center for dietary supplement companies and regulators. Speakers will examine recent legislation related to dietary supplements and the potential impact on industry, discuss FDA’s current priorities for dietary supplement product regulation, and address current challenges facing the industry, from litigation to supply concerns.

Steven M. Mister, President and Chief Executive Officer, Council for Responsible Nutrition
David C. Spangler, Senior Vice President, Legal, Government Affairs & Policy, Consumer Healthcare Products Association and Member, FDLI Board of Directors
Cara Welch, Director, Office of Dietary Supplement Programs, CFSAN, FDA
Moderated by Diane C. McEnroe, Partner, Sidley Austin LLP

This panel will focus on whether the PMTA process adequately accounts for the protection of public health. Panelists will consider the process itself, as well as the application of this process via FDA’s marketing approval and denial orders. Speakers will also consider the potential policy implications of FDA’s PMTA decisions, what the PMTA process gets wrong and whether it can be improved within the current statutory confines, and whether this process means that PMTA products are regulated in a way that does not effectively contribute to the reduction of the negative health effects of tobacco use.

David L. Ashley, Research Professor, Department of Population Health Sciences, Georgia State University
Aruni Bhatnagar, Professor of Medicine and Distinguished University Scholar, University of Louisville
Jason W. Flora, Associate Fellow, Regulatory Affairs, Altria Client Services
Christopher Junker, Vice President, Scientific & Regulatory Affairs, RAI Service Company
Moderated by Thomas J. Glynn, Adjunct Lecturer, Stanford University

Since the release of FDA’s guidance for industry, “Regulation of Intentionally Altered Genomic DNA in Animals”, questions about what this means for global food demand, animal welfare, and medical advancement are more important now than ever. The guidance estimates a two-year release of IGA to the market, what is industry response and public perception of this timeline? What challenges will industries face between approval and the marketplace?

Laura Epstein, Senior Policy Analyst, CVM, FDA
Jaydee Hanson, Policy Director, Center for Food Safety
Alison Van Eenennaam, Cooperative Extension Specialist, University of California-Davis
Moderated by Kristin M. Kaplan, Of Counsel, Shook, Hardy & Bacon LLP

4:30–5:30 PM | Concurrent Breakout Sessions 3

During this session, FDA leadership will address the top issues CDRH is facing as well as priorities and goals for the coming year.

Jeffrey E. Shuren, Director, Center for Devices and Radiological Health, FDA 
Moderated by Melanie Katrice Gross, Associate General Counsel & Practice Group Leader, Healthcare Law Group, Genentech, Inc. and Member, FDLI Board of Directors

Laurie Lenkel, Ombudsman, Office of the Chief Scientist, FDA
Ken Skodacek, Deputy Ombudsman, CDRH, FDA
Jessica L. Zeller, Vice President, Quality, Regulatory & Public Affairs Counsel, Edwards Lifesciences
Lowell M. Zeta, Partner, Hogan Lovells US LLP
Moderated by Cynthia Schnedar, Principal, Regulatory Compliance, Greenleaf Health, Inc. and Member, FDLI Board of Directors

Lola Fashoyin-Aje, Deputy Division Director & Associate Director, Science & Policy to Address Disparities, Oncology Center of Excellence, FDA
Kimberly Gold, Chief Privacy Officer, Genentech, Inc.
Peter V. Lindsay, Partner, Paul Hastings, LLP
Peter Stein, Director, Office of New Drugs, CDER, FDA
Moderated by Stacy Cline Amin, Partner, Morrison & Foerster, LLP

Jeremiah Fasano, Senior Policy Advisor, Office of Food Additive Safety, CFSAN, FDA
Kelly G. Laudon, Of Counsel, Jones Day
Nicole Negowetti, Vice President of Policy & Food Systems, Plant Based Foods Association
Moderated by Jessica Tierney, Senior Counsel, Thompson Hine LLP

Clifford E. Douglas, Director, Tobacco Research Network and Adjunct Professor, Department of Health Management and Policy, University of Michigan School of Public Health
J.B. Simko, Vice President, External Affairs, Philip Morris International
Joe Murillo Chief Regulatory Officer, JUUL Labs
Moderated by Stacy L. Ehrlich, Partner, Kleinfeld, Kaplan & Becker LLP

Jonathan A. Havens, Partner, Saul Ewing Arnstein & Lehr LLP
Pritika Kumar, Senior Fellow, Integrated Harm Reduction Policy, R Street Institute
Raymond Niaura, Professor, Department of Social and Behavioral Sciences, New York University
Moderated by Frederick R. Ball, Partner, Duane Morris LLP and Treasurer, FDLI Board of Directors

Wednesday, June 15

Laura Brown, Director, Educational Programs, FDLI
Meredith Quinn Olearchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law, Campbell Soup Company and Co-Chair, 2022 FDLI Annual Conference

The Service to FDLI Award, established in 2017, honors FDLI members who have provided exceptional volunteer services to FDLI, furthering FDLI’s mission as a neutral convener to educate and spark innovative change.

Award Recipient: Stuart M. Pape, Senior Partner, Polsinelli PC

A lectureship named in honor of Dr. Harvey W. Wiley, the renowned physician-chemist who, at the turn of the 20th century, championed a legislative crusade against food adulteration, earning him the title of “Father of the Pure Food and Drugs Act” when it was enacted into law in 1906.

 

Janet Woodcock, Principal Deputy Commissioner, Office of the Commissioner, FDA
Introduced by Deborah M. Autor, CEO, Autor Strategies; Non-Executive Director, Pardes Biosciences; and Chair, Board of Directors, FDA Alumni Association

During this panel, industry in-house counsel will discuss challenges faced by FDA-regulated companies. They will examine the wide breadth of current matters challenging industry, including navigating regulatory uncertainty, changes arising from Covid-19 and moving beyond the pandemic, cybersecurity, enforcement by other agencies, social responsibility, and what they anticipate for the future.

Kenita Barrow, Deputy General Counsel, Legal Affairs, Otsuka America Pharmaceutical, Inc.
Amy Norris, Executive Counsel, Clif Bar and Secretary and General Counsel, FDLI Board of Directors
Steven Przybyla, General Counsel, 22nd Century Group, Inc.
Ami Simunovich, EVP and Chief Regulatory Officer, BD
Jennifer Zachary, Executive Vice President and General Counsel, Merck & Co., Inc.
Moderated by Freddy Jimenez, Senior Vice President and General Counsel, Celldex Therapeutics, Inc. and Vice Chair, FDLI Board of Directors

11:05 AM–12:05 PM | Concurrent Breakout Sessions 4

Michele Mital, Acting Director, Center for Tobacco Products, FDA

Hear directly from those negotiating the user fee program reauthorization for prescription drugs (PDUFA), generic drugs (GDUFA), biosimilars (BsUFA), and medical devices (MDUFA) on the current state of the goals letters and accompanying omnibus reauthorization legislation. Speakers will address FDA-related policy priorities set forth in the legislation and the regulatory and legal impacts for industry

Margaret Coulter, Senior Health Policy Advisor, Committee on Health, Education, Labor and Pensions, US Senate
Kelly F. Goldberg, Vice President, Law & Senior Counsel for Biopharmaceutical Regulation, PhRMA
Moderated by Wade Ackerman, Partner, Covington & Burling LLP

FDA’s regulation of and policies on orphan drug designations and exclusivities continue to evolve and be challenged in court, sometimes with surprising results given FDA’s prior regulation of this area. A recent example is the Catalyst decision, which seems to broaden the scope of orphan drug exclusivity. This panel will discuss how FDA may implement or respond to this and what additional modifications to the Orphan Drug Act might be made in light of Catalyst and other recent decisions. Speakers will also address new regulatory developments, including FDA’s new guidance on “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations” and potential areas of risk and remaining uncertainties for sponsors.

Brian J. Malkin, Partner, McDermott Will & Emery
Michael K. Stern, Of Counsel, Covington & Burling LLP

John Claud, Assistant Director, Civil Division, U.S. Department of Justice
James C. Fraser, Shareholder, Greenberg Traurig, LLP
Gregory H. Levine, Partner, Ropes & Gray LLP
Anne K. Walsh, Director, Hyman, Phelps & McNamara, PC

The FDA Food Safety Modernization Act (FSMA) has aimed to transform the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it. How successful has the new structure been in increasing food safety? During this panel, speakers will consider enforcement and compliance actions as well as recalls to highlight the changes FSMA has brought about, FDA’s priorities, and areas where improvements in food safety is still needed. Speakers will then discuss what’s next, as FDA implements its New Era of Smarter Food Safety.

Greg Bikofsky, Independent Consultant, EAS Consulting Group, LLC
Meredith Q. Olearchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law, Campbell Soup Company and Co-Chair, 2022 FDLI Annual Conference
Ann M. Oxenham, Acting Director, Office of Compliance, CFSAN, FDA
Moderated by Suzie Trigg, Partner, Haynes and Boone LLP

The changing media landscape has led to the rise of new ways of marketing to consumers and the use of influencers. Companies have been engaging with these new venues, but the compliance concerns are real, and both FDA and FTC are taking action. The FTC has put over 700 food, OTC drugs, cosmetics, and dietary supplement companies on notice that it plans to use its Penalty Offense Authority to deter fake reviews and deceptive endorsements in the online world. This panel will discuss why FTC resurrected this enforcement tool, how to market effectively on new and cutting-edge social media platforms, and pitfalls brands and advertisers face as the FDA and FTC take a hard look at their enforcement priorities.

Richard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, Federal Trade Commission
Jason W. Gordon, Partner, Reed Smith LLP
Alan G. Minsk, Partner, Arnall Golden Gregory LLP
Sarah H. Stec, Senior Counsel, Medical Device Regulatory Law, Johnson & Johnson

1:00–2:00 PM | Concurrent Breakout Sessions 5

During this session, FDA leadership will address the top issues CFSAN is facing as well as priorities and goals for the coming year.

Susan T. Mayne, Director, Center for Food Safety and Applied Nutrition, FDA
Douglas W. Stearn, Deputy Director, Regulatory Affairs, CFSAN, FDA
Moderated by Ricardo Carvajal, Director, Hyman, Phelps & McNamara, PC and Member, FDLI Board of Directors

Moderated by Derrick Gingery, Senior Writer, Informa Pharma Intelligence

Join speakers on an expedition into the patent-verse. This session will discuss the future of label carveouts for generics and biosimilar applicants as a way to avoid inducing patent infringement following the Federal Circuit’s 2021 GSK v. Teva decision. How will this decision impact the generic drug industry and affordability to patients? Is skinny labeling the only method to market a generic drug within the life cycle of an active patent? What impact would the potential demise of the skinny label have on generic competition?

Karin Hessler, Deputy General Counsel, Association for Accessible Medicine
Sara W. Koblitz, Director, Hyman, Phelps & McNamara, PC
Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP
Jeremy Sharp, Managing Director, Waxman Strategies

William G. Morice, Chair, Department of Laboratory Medicine and Pathology, Mayo Clinic
Elizabeth Richardson, Director, Health Care Products Project, The Pew Charitable Trusts
Timothy Stenzel, Director, Office of In Vitro Diagnostics and Radiological Health, CDRH
Moderated by Bethany Hills, Partner,  DLA Piper (US), LLP

Ryan Fischer, Chief Advocacy Officer, Parent Project Muscular Dystrophy
Larissa Lapteva, Associate Director, Division of Clinical Evaluation, Pharmacology and Toxicology, Offices of Tissues and Advanced Therapies, CBER, FDA
Jewell Martin, Associate Director for US Regulatory Policy, BioMarin Pharmaceutical Inc.
Moderated by Kristin M. Zielinski Duggan, Partner, Hogan Lovells US LLP

Dennis Henigan, Vice President, Legal and Regulatory Affairs, Campaign for Tobacco-Free Kids
Beth Oliva, Partner, Fox Rothschild LLP
John Pritchard, Vice President of Regulatory Science, 22nd Century Group, Inc.

2:10–3:10 PM | Concurrent Breakout Sessions 6

During this session, FDA leadership will address the top issues CBER is facing as well as priorities and goals for the coming year.

Peter W. Marks, Director, Center for Biologics Evaluation and Research, FDA 
Moderated by Michael Werner, Partner, Holland & Knight LLP

Jeffrey K. Francer, Senior Vice President & General Counsel, Association for Accessible Medicines
Brian R. McCormick, Vice President, Chief Regulatory Counsel, TEVA Pharmaceuticals USA, Inc.
Eileen McMahon, Partner, Torys LLP
Moderated by Howard R. Sklamberg, Partner, Arnold & Porter LLP

Jamie W. Gamerman, Regulatory Counsel, CDER, FDA
Winston S. Kirton, Partner, Winston & Strawn LLP
Ravyn R. Miller, Vice President, Portfolio Strategy and Business Development, Defibrillation Solutions, Medtronic
Kaveeta Vasisht, Associate Commissioner for Women’s Health, Office of Women’s Health, Office of the Commissioner, FDA
Madison Wheeler, Director of Technical Operations, EMMA International

Sonja Fulmer, Assistant Director, Digital Health Policy Leadership and Development, Digital Health Center of Excellence, CDRH
Sonia W. Nath, Partner, Cooley LLP
Cassie Scherer, Director of Regulatory Policy, US, Medtronic

Joseph M. Dages, Associate, Steptoe & Johnson LLP
John Hewitt, Vice President, Packaging Sustainability, Consumer Brands Association

Tony Abboud, Executive Director, Vapor Technology Association
Neal L. Benowitz, Professor of Medicine Emeritus (Active), University of California – San Francisco>
Michael Shane Benson, Compliance Counsel, Turning Point Brands, Inc.

Always informative and entertaining, this perennially popular session promises insight into the most significant current litigation and a look at cases to keep an eye on in the coming year. Annual Conference attendees receive the companion e-publication, Top Food and Drug Law Cases 2021, and Cases to Watch, 2022.

Ralph F. Hall, Professor of Practice, University of Minnesota
Erika F. Lietzan, William H. Pittman Professor of Law & Timothy J. Heinsz Professor of Law, University of Missouri – Columbia School of Law
Ginger Heyman Pigott, Shareholder, Greenberg Traurig, LLP
Moderated by August T. Horvath, Partner, Foley Hoag LLP