Thursday, December 9, 2021
11:00–11:25 AM
FDLI Welcome, Introductions, and Keynote Address
Laura Brown, Director, Educational Programs, FDLI
Arun G. Rao, Deputy Assistant Attorney General, Consumer Protection Branch, Civil Division, US Department of Justice
Bob Rhoades, Managing Partner, Validant and Chair, 2021 Enforcement, Litigation, and Compliance Conference
11:30–11:55 AM
Fireside Chat
Julia G. Tierney, Chief of Staff, Office of the Commissioner, FDA
Interviewed by Stacy Cline Amin, Partner, Morrison and Foerster, LLP
12:00–12:10 PM
In Memoriam Remarks for Bill Correll
Susan Mayne, Director, CFSAN
12:15–2:15 PM
Compliance Central with FDA Center Compliance Directors: Presentations and Q&A
Donald D. Ashley, Director, Office of Compliance, Center for Drug Evaluation and Research, FDA
Jennifer Erickson, Regulatory Counsel, Center for Veterinary Medicine, FDA
William Maisel, Director, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, FDA
Melissa Mendoza, Deputy Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, FDA
Ann M. Oxenham, Acting Director, Office of Compliance, Center for Food Safety and Applied Nutrition, FDA
Ann L. Simoneau, Director, Office of Compliance and Enforcement, Center for Tobacco Products, FDA
Moderated by Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Immediate Past Chair, FDLI Board of Directors
2:15–2:45 PM
Break
2:45–3:45 PM
Concurrent Breakout Sessions
- Lessons Learned for Medical Products from COVID-19: Enforcement and Compliance Risks and Strategies for Navigating the Future
Sonali P. Gunawardhana, Chief Counsel, FDA & Regulatory, McKesson Corporation and Member, FDLI Board of Directors
Winston S. Kirton, Partner, Winston & Strawn LLP
Anne K. Miller, Legal Counsel, Medtronic
Moderated by J. Benneville (Ben) Haas, Partner, Latham & Watkins LLP
- Evaluating FSMA and Looking Toward the Future of Food Safety
Meredith Quinn Olearchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law, Campbell Soup Company
Allen Sayler, Independent Consultant, EAS Consulting Group
Douglas W. Stearn, Deputy Director, Center for Food Safety and Applied Nutrition, FDA
Moderated by Smitha G. Stansbury, Partner, King & Spalding LLP
- FDA Tobacco Enforcement in a Post-Compliance Policy World: Current Status and Future Implications
Michael Cummings, Professor, Medical University of South Carolina
Stacy L. Ehrlich, Partner, Kleinfeld, Kaplan & Becker, LLP
Bryan M. Haynes, Partner, Troutman Pepper Hamilton Sanders LLP
Patricia M. Miller, Managing Director, Regulatory Affairs, Altria Client Services LLC
- Safe Writing (LOL!) – How to Prevent Communications From Becoming a Liability
Adrienne Franco Busby, Partner, Faegre Drinker Biddle & Reath LLP
Michael W. King, Vice President & Associate General Counsel, Litigation, Employment Law and Privacy, Jazz Pharmaceuticals
Ronald J. Levine, Independent Consultant, EAS Consulting Group
4:00–5:00 PM
Continuing Impact of FDA’s Inspection Approach on Industry and What Happens Next
Peter V. Lindsay, Partner, Paul Hastings
Elizabeth Miller, Assistant Commissioner Medical Products and Tobacco Operations, Office of Regulatory Affairs, FDA
Stephanie M. Haggerty, Senior Corporate Counsel, Pfizer Inc.
Moderated by Cathy L. Burgess, Partner, Alston & Bird LLP and Member, FDLI Board of Directors
Friday, December 10, 2021
11:00–11:55 AM
FDLI Welcome
Amy Comstock Rick, President & CEO, Food and Drug Law Institute
The False Claims Act and the Life Sciences Industry: Trends, Case Developments, and Risks
Sarah Cummings, Partner, Reed Smith LLP
Colin Huntley, Deputy Director, Commercial Litigation Branch – Fraud Section, Civil Division, U.S. Department of Justice
Kelsey Schaefer, Associate Chief Counsel, Office of the Chief Counsel, FDA
Beth P. Weinman, Counsel, Ropes & Gray LLP
12:00–12:45 PM
Concurrent Breakout Sessions
- The Aftermath of AMG: The Future of FTC Actions and Impact on FDA Enforcement
John Claud, Assistant Director, Civil Division, U.S. Department of Justice
Sonia W. Nath, Partner, Cooley LLP
Kristi L. Wolff, Partner, Kelley Drye & Warren LLP
- Enforcement Actions in the Human Cell, Tissue, and Cellular and Tissue-based Product or HCT/Ps Arena
Cori Annapolen Goldberg, Partner, ReedSmith LLP
Michael Helbing, Associate Chief Counsel for Litigation, Office of the Chief Counsel, FDA
Steven A. Johnson, Vice President – Compliance & Legal Affairs, Zogenix, Inc.
Michael Werner, Partner, Holland & Knight LLP
- Diagnostics: FDA Policies, Enforcement Priorities, and Pending Legislation
Brigid Bondoc, Of Counsel, Morrison Foerster, LLP
Carly McWilliams, Head of Regulatory Policy for Roche Diagnostics
Moderated by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC
- Preparing for Tobacco Product Standards and cGMPs
Stacey Gagosian, Managing Director, Public Policy, Truth Initiative
Neelam Gill, Associate, Keller and Heckman LLP
Beth G. Oliva, Partner, Fox Rothschild LLP
Moderated by Kristin M. Kaplan, Of Counsel, Shook, Hardy & Bacon LLP
1:00–2:00 PM
Concurrent Breakout Sessions
- Enforcement & Compliance Issues and Their Impact on Due Diligence in Transactions Involving FDA-Regulated Companies and Products
John (“Jack”) C. Garvey, Managing Partner, Compliance Architects LLC
Michael A Swit, Sr. Corporate Counsel, Regulatory Affairs, Varian Medical Systems
Suzie L. Trigg, Partner, Haynes and Boone LLP
Moderated by Maya P. Florence, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
With the increasing difficulties in internally-generated product development, FDA-regulated companies of all sizes increasingly are looking to deals to augment product lines. Whether in the form of single products or whole companies, transactions can make or break the future of your company. However, often lost is the critical need to ensure that regulatory, clinical and quality considerations do not undermine the value or viability of a deal. This session will address the key regulatory, clinical or quality issues – including data integrity failings – that must be reviewed when purchasing an FDA-regulated product or company and how to address those concerns in the due diligence phase.
- Ensuring Data Reliability, Patient Safety, and Preventing Fraud in Clinical Trials
Gustav Eyler, Director, Consumer Protection Branch, U.S. Department of Justice
Cynthia Schnedar, Principal, Greenleaf Health, Inc. and Member, FDLI Board of Directors
Jill Furman, Deputy Director, Office of Compliance, CDER, FDA
Moderated by Ethan Davis, Partner, King & Spalding LLP
In recent months, DOJ has prosecuted individual clinical trial investigators and contract research organizations – how did we get here? The panel will explain the significance of the focus on clinical trial fraud, the use of data analytics in identifying enforcement targets, and the importance of maintaining data integrity during a pandemic that has disrupted clinical trial operations. Current and former government officials will discuss FDA and DOJ enforcement activity involving clinical trial fraud, how companies can maintain data integrity to prevent enforcement as well as exercise adequate oversight over contract research organizations, and finally, how companies can interface with government agencies to prevent this level of enforcement.
- Data Privacy: The Enforcement, Litigation, and Compliance Landscape Under Increasing State, Federal, and International Regulation
Andrew C. Fish, Executive Director, AdvaMed Center for Digital Health
Kim Gold, Chief Privacy Officer, Head of Privacy Law Group and Associate General Counsel, Genentech
Jami Vibbert, Partner and Leader, Privacy, Cybersecurity & Data Strategy, Arnold & Porter LLP
The privacy and protection of some health data in the United States traditionally was only governed by HIPAA. Moreover, much of the health data in the hands of life sciences companies traditionally does not come within the ambit of HIPAA. Now, the EU and three states, (and soon to be more) govern the privacy and security of health data as sensitive. This panel will explore different types of health data collected by life sciences companies, both traditional and new uses of such data, and how that health data may be regulated by state, federal, or privacy laws. Panelists will also discuss strategies for handling compliance with and homogenizing response to these privacy laws.
- Environmental, Social, and Governance Claims (ESG) Claims – Pitfalls and Strategies
Raqiyyah Pippins, Partner, Arnold & Porter LLP
William Stellmach, Partner, Willkie Farr & Gallagher LLP
Moderated by Sally R. K. Fisk, Vice President & Assistant General Counsel, Environmental & Sustainability Law, Pfizer Inc.
Consumers are showing an increased interest in brands that consider the impact a company has on its employees, customers, and communities where it operates via demonstrable corporate commitments to environmentally friendly practices, social equity, and responsible governance. For companies that wish to promote or make claims based on ESG, these terms are not regulated by FDA and can present serious risks. Speakers will discuss the tools needed to address enforcement and litigation pitfalls, mitigate risk, and further prepare your business.
2:15–3:00 PM
The Theranos Trial: Lessons Learned for Industry from a Complex Case
Hannah R. Bornstein, Partner, Nixon Peabody LLP
William Gould, Partner, Holland & Knight LLP
Peter J. Leininger, Partner, King & Spalding LLP
In August, in a highly publicized case, the trial began for former President and CEO of Theranos, Elizabeth Holmes, who has been indicted on an array of fraud charges related to the company’s failed blood diagnostic tests. The case highlights common pitfalls for individuals in FDA-regulated companies handling serious product quality and regulatory concerns, as well as subsequent litigation issues. The case also highlights DOJ’s ongoing focus on consumer protection. This panel will use this case as a case study to discuss lessons learned for a wide array of industries, including drugs, medical devices, and food.
3:10–4:00 PM
Updates in Litigation Risks for FDA-Regulated Companies: Product Liability, Private Litigation, Consumer Class Actions, and More
Brian Burgess, Partner, Goodwin Procter LLP
James C. Fraser, Shareholder, Greenberg Traurig, LLP
Donnelly McDowell, Partner, Kelly Drye & Warren LLP
Moderated by Anne K. Walsh, Director, Hyman, Phelps & McNamara, PC
This panel will focus on crucial litigation trends, including state-based class actions, FDA enforcement, private litigation, and upcoming areas of risk, including post-pandemic litigation. Panelists will discuss how to best mitigate the risk of litigation and areas to watch for the future.
4:00 PM
Closing Remarks and Adjournment