Why Attend

Agenda

subject to change
All times are in Eastern Time

CLE

Thursday, December 9

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

This session will address FDA’s top compliance issues, enforcement priorities, and goals for 2022. Hear directly from each FDA Center Compliance Director, learn how industry should focus its compliance efforts, and what to expect when you don’t follow FDA regulations. Following the presentations, the audience will have the opportunity to ask questions of the Center Compliance 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

COVID-19 brought many changes to the medical product space, including remote assessments, emergency product authorizations, supply chain shortages, and more. What lessons can be gleaned from industry’s COVID-19 experiences, and how can companies use these experiences to navigate and manage enforcement and compliance risks in the near future?

  • 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

FSMA was signed into law ten years ago, and regulations implementing FSMA are now in place. During this panel, speakers will discuss FSMA as a quality system to create a safer overall food system. Panelists will consider enforcement actions that have come about from FSMA implementation, analyze enforcement trends to consider whether the goals of FSMA are being met, and practical tips on key issues for industry.

  • 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

Now past the September 9, 2021 deadline for Premarket Tobacco Applications (PMTAs) and other requests for marketing authorization for tobacco and nicotine products not on the market prior to February 15, 2007, FDA has issued Refuse to File (RTF) and Marketing Denial Orders (MDOs) in response to PMTAs that cover millions of products. Any product with a RTF or MDO may no longer be legally sold on the market, but questions abound about enforcing these decisions in light of FDA’s limited resources and the lack of publicly available information regarding the specific products covered. Panelists will review recent FDA enforcement activities, discuss potential approaches such as better collaboration with state and local governments, and address current and looming concerns including the frequent appearance of synthetic nicotine products that arguably fall outside of FDA’s regulatory authority.

  • 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

Rule #1: Think Twice, Click Once. Rule #2: Refer to rule #1. Everything lives indefinitely, especially in our digital world, and is potentially discoverable in litigation. Careless written words in letters, text messages, emails, and social media posts can become a major challenge to defend against. How can companies employ protections that guard against adversaries and educate employees without it looking like a coverup? This session will delve into what constitutes writing safe content, discussions on technological solutions, and practical tips for ensuring smart communications.

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

Significant discussion has focused on FDA’s approach over the last year of using record requests and remote evaluations during the COVID-19 pandemic. This session will highlight the latest developments on FDA’s resumption of in-person inspections, including FDA’s implementation of its Resiliency Roadmap, and, just as important, it will also focus on the significant impact of the pandemic inspection pause on industry. This session will cover industry experience with remote evaluations and record requests, FDA’s suggested approach to and preparations for hybrid reviews, and opportunities for mitigating any negative impact from the period of reduced oversight and supervision, both at industry’s own sites as well as within the broader supply chain supporting those sites.

Friday, December 10

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

In 2020 and 2021, we saw a continuing focus by the Federal government and private whistleblowers on False Claims Act enforcement, particularly against those operating in the healthcare space. Cases against drug and medical device manufacturers, managed care providers, hospitals, pharmacies, hospice organizations, laboratories, and physicians accounted for US $1.8 billion of federal FCA recoveries in 2020, with additional recoveries worth tens of millions for state Medicaid programs. This panel will consider the trends in False Claims Act litigation and settlements, including those related to the pandemic, and what can be expected in terms of regulatory framework and volume of FCA enforcement going forward.

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

In this session, speakers will discuss the Supreme Court’s ruling in AMG Capital Management, LLC v. FTC, which held that the FTC does not have the authority to seek equitable monetary relief under Section 13(b) of the FTC Act. What are the implications of this ruling for FDA-regulated industry and civil or criminal enforcement brought by FDA? Could the decision chill FDCA enforcement? What tools FDA may turn to rather than focusing on remedies implicated by the AMG decision?

  • 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

FDA’s period of enforcement discretion on these products ended on May 31, 2021. This panel will delve into FDA and DOJ enforcement actions in the HCT/P space, including actions involving stem cell therapies. Speakers will provide background on HCT/Ps and the regulatory landscape governing such products, discuss pivotal recent legal cases, and examine upcoming compliance and enforcement initiatives and potential risks for industry.

  • 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

This panel will address FDA’s policies for diagnostic tests (LDTs, DTC, at-home, pharmacogenetic, wellness tests, COVID tests, etc.) and the shifting sands over the last several years. Speakers will examine FDA warning letters and other compliance and enforcement activities that have had an impact on the industry. The panel will also examine what would change under the VALID Act as well as what the compliance and enforcement landscape might look like in the future.

  • 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

Announced as a focal point of future regulation in 2017, updates and guidance on both product standards for nicotine content and Tobacco Product Manufacturing Practices (TPMPs) are still pending. This session will feature a review of recent marketing granted orders, plus existing product standards and GMPs for other FDA-regulated products, to predict what they may look like for tobacco and nicotine products. Panelists will also discuss practical challenges for creating TPMPs for electronic nicotine delivery systems (ENDS) considering the variety of products that may ultimately receive marketing orders.

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