Wednesday, December 7
8:30–9:00 AM
Registration and Continental Breakfast
9:00–9:40 AM
FDLI Welcome, Opening Remarks, and Keynote Address
Christine M. Simmon, President & CEO, Food and Drug Law Institute
William F. Gould, Partner, Holland & Knight LLP and Co-Chair, FDLI Enforcement, Litigation, and Compliance Conference
Anne K. Miller, Legal Counsel, Medtronic and Co-Chair, FDLI Enforcement, Litigation, and Compliance Conference
Keynote Address
Arun G. Rao, Deputy Assistant Attorney General, Consumer Protection Branch, Civil Division, U.S. Department of Justice
9:45–11:00 AM
Compliance Central with FDA Center Compliance Directors
Jill Furman, Acting Director, Office of Compliance, Center for Drug Evaluation and Research, FDA
Ele Ibarra-Pratt, Deputy Director, Office of Compliance and Enforcement, Center for Tobacco Products, FDA
Melissa Mendoza, Deputy Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, FDA
Ann Oxenham, Director, Office of Compliance, Center for Food Safety and Applied Nutrition, FDA
Timothy C. Schell, Director, Office of Surveillance and Compliance, Center for Veterinary Medicine, FDA
Keisha Thomas, Acting Associate Director, Compliance and Quality Staff, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, FDA
Moderated by Cathy L. Burgess, Partner, Alston & Bird LLP and Member, FDLI Board of Directors
This session will address FDA’s top compliance issues, enforcement priorities, and goals for 2023. Hear directly from each FDA Center Compliance Director, learn how industry should focus its compliance efforts, and understand the consequences of not following FDA regulations.
11:00–11:20 AM
Networking Break
11:20 AM–12:20 PM
Concurrent Breakout Sessions 1
- The Relationship Between Outside Counsel Investigations and Quality System Investigations, and What to Do when they Conflict
Thomas J. Cosgrove, Partner, Covington and Burling LLP
Sonali P. Gunawardhana, Assistant General Counsel – Regulatory, Cardinal Health, Inc.
Anne K. Walsh, Director, Hyman, Phelps & McNamara, PC
Moderated by Daniel G. Jarcho, Partner, Alston & Bird LLP
When serious CGMP compliance issues arise, it is commonplace for outside counsel to do a privileged internal investigation. At the same time, the company has a CGMP obligation to do a quality investigation that is not privileged and is available to FDA during an inspection. This session will address the relationship between the two investigations. Speakers will address the challenges that can arise, such as when the privileged investigation by outside counsel uncovers facts not known to those handling the quality investigation, including how counsel can communicate about such facts with quality investigators while still maintaining the attorney-client privilege.
- Dietary Supplement Enforcement and Compliance Update
Aaron M. Danzig, Partner, Arnold Golden Gregory LLP
Megan Olsen, Senior Vice President & General Counsel, Council for Responsible Nutrition
Patrick Runkle, Senior Litigation Counsel, Consumer Protection Branch, U.S. Department of Justice
Douglas W. Stearn, Deputy Director for Regulatory Affairs, CFSAN, FDA
FDA has been increasing its focus on enforcement in the dietary supplement space, which has been mirrored in DOJ litigation. This panel will discuss where FDA efforts have been focused, including on compliance with applicable GMPs, and how pending dietary supplement legislative reform could impact the industry and FDA enforcement.
- Tobacco-Focused Litigation Update
Bryan M. Haynes, Partner, Troutman Pepper Hamilton Sanders LLP
Eric Heyer, Partner, Thompson Hine LLP
Beth G. Oliva, Partner, Fox Rothschild LLP
Moderated by Kenneth E. Warner, Avedis Donabedian Distinguished University Professor Emeritus and Dean Emeritus, University of Michigan School of Public Health
Dozens of lawsuits have been filed by companies challenging marketing denial orders (MDOs) issued by FDA as an outcome of the Premarket Application Process. Panelists will provide an update on these cases and the positions taken by the litigants, many of which claim that FDA acted in an arbitrary and capricious manner not in line with previously finalized guidance and rules. Panelists will further discuss the “arbitrary and capricious” standard, which has also been noted in FDA’s efforts to regulate cigars. Finally, speakers will consider graphic warning labels for cigarettes and implications for protected corporate speech under the First Amendment.
12:20–1:30 PM
Networking Luncheon
1:30–2:30 PM
Concurrent Breakout Sessions 2
- Creating a Quality Culture: Warding Off Whistleblowing (And What to Do if the Whistle is Blown on Your Company)
Peter V. Lindsay, Partner, Paul Hastings, LLP
Fred Medick, Assistant General Counsel, Genentech, Inc.
Michelle Quinn, Deputy General Counsel, Chief Compliance Officer, Becton Dickinson (BD)
Moderated by Cynthia L. Schnedar, Principal, Greenleaf Health, Inc. and Member, FDLI Board of Directors
As companies continue to advance their compliance programs, the use of tools such as reportable metrics – an area of focus for FDA – are critical to everything from management review to data integrity to compliance hot lines. How are companies using these tools to support a sustainable culture of compliance so that there is no need to blow the whistle on the company’s practices? If it happens anyway, what steps should a company take to protect itself when the government is investigating a whistleblower’s complaint?
- Clinical Trial Fraud: Protecting Data Integrity
Tal Bar-El, General Counsel for R&D Legal, TEVA Pharmaceuticals, Inc.
Chrissy Cochran, Director, Office of Bioresearch Monitoring, ORA, FDA
Julie K. Tibbets, Partner, Goodwin Procter LLP
Blake E. Wilson, Partner, Hogan Lovells US LLP
DOJ has identified clinical trial fraud as a key area of enforcement focus, particularly on cases involving falsified clinical data. This focus is in addition to risks from FDA regulatory enforcement, criminal penalties under the FDCA, and reputational damage. What are the responsibilities and best practices at the sponsor level to ensure that data integrity is protected? What is the role of FDA’s Bioresearch Monitoring (BIMO) Program in ensuring that industry research programs remain on-track, and what trends can be gleaned from recent BIMO inspections and warning letters?
- The FDCA Impact of Dobbs
Susan S. Lee, Partner, Goodwin Procter LLP
Rachel Sher, Partner, Manatt, Phelps & Phillips, LLP
Eva Temkin, Partner, King & Spalding LLP
Moderated by Bridget C. E. Dooling, Research Professor, GW Regulatory Studies Center
In June of this year, the Supreme Court overturned longstanding federal precedent found in Roe v. Wade and Casey v. Planned Parenthood, significantly disrupting the provision of reproductive health services. This ruling has the potential to have far-reaching impacts on FDA-regulated companies as well, which is where this panel will focus. In the wake of Dobbs, can states prevent companies from selling a drug that has been approved by FDA? What are the implications for a sponsor conducting clinical trials with pregnant patients, and subsequent data privacy concerns? What are the implications for digital health apps regulated by FDA? What are obligations and pitfalls for enforcement, especially if that enforcement is state-level and conflicts with FDA jurisdiction?
2:45–3:45 PM
Concurrent Breakout Sessions 3
- Secondary Impacts of Warning Letters: Due Diligence, Litigation Exposure, and More
Stephanie M. Haggerty, Senior Corporate Counsel, Pfizer, Inc.
Philip Johnson, Senior Principal, IQVIA
Areta L. Kupchyk, Partner, Foley Hoag LLP
Moderated by Kristin M. Kaplan, Of Counsel, Shook, Hardy & Bacon LLP
When a company receives a warning letter, the first (and most discussed) priority is responding to FDA’s concerns. However, what is frequently overlooked are the secondary impacts of receiving a warning letter, especially a warning letter setting forth GMP violations. These impacts can include product-related litigation, recalls, loss of customer trust, increased oversight by third parties, impacts on current or future due diligence, and harm to company reputation. This session will discuss strategies for addressing these secondary impacts.
- FDA’s Recent Medical Device Recalls and Enforcement, Use of Section 518 Authority, and How to Best Prepare
Shelby Buettner, Associate General Counsel, Regulatory Law and Compliance Officer, Becton Dickinson (BD)
Dennis C. Gucciardo, Partner, Morgan, Lewis & Bockius LLP
Anne K. Miller, Legal Counsel, Medtronic and Co-Chair, FDLI Enforcement, Litigation, and Compliance Conference
Joshua M. Oyster, Partner, Ropes & Gray LLP
During this session, panelists will explore the landscape of medical device recalls, including the uptick in Class I recalls and the recent return of the rarely used authorities under section 518 of the FDCA, as seen in the Phillips recall. Speakers will also discuss how stakeholders should prepare for recall decisions and related communications, which often require balancing of various internal and external perspectives to comply with legal and regulatory requirements. With the recent uptick in Class I classifications, FDA’s communication approach must also be considered. These perspectives and practical advice are also useful for other FDA-regulated products.
- FDA Enforcement Priorities and Actions in Tobacco and Nicotine Products
Tony Abboud, Executive Director, Vapor Technology Association
Agustin Rodriguez, Partner, Troutman Pepper Hamilton Sanders LLP
Moderated by Scott Ballin, Health Policy Consultant
CTP is visibly increasing its enforcement on tobacco products, with the notable October announcement seeking permanent injunction against six e-cigarette manufacturers. Speakers will discuss these actions, as well as what can be learned from recent warning letters about additional FDA priorities. Speakers will consider the top reasons that FDA has issued warning letters in the tobacco space, how often warning letters are resolved without further action, and how warning letters are most often resolved.
3:45–4:15 PM
Networking Break
4:15–5:15 PM
The White-Hot Spotlight: How Media Portrayal of FDA Impacts Litigation and Juries
Adrienne Franco Busby, Partner, Faegre Drinker Biddle & Reath LLP
John H. Fuson, Partner, Crowell & Moring LLP
Alexis K. Knutson, Trial Consultant, Sound Jury Consulting
Peter J. Leininger, Partner, King & Spalding LLP
Theranos. Dopesick. Covid-19 vaccines. Public Advisory Committee Meetings. Food safety recalls. Examples of recent high-profile media coverage and Hollywood dramatizations of FDA-regulated products are abundant. These stories, both factual and fictional, infiltrate jurors’ minds, impacting the opinions of the FDA and in turn, the outcome of legal cases. Implications include jurors’ perception of regulators post-pandemic, how they view and interpret scientific evidence, and how enforcement actions are perceived. Whether the proceedings are criminal or civil, understanding how jurors perceive the FDA can help companies to manage risk on the front end, even before litigation arises.
5:15–7:30 PM
FDLI 2022 Annual Holiday Reception
Thursday, December 8
8:30–9:00 AM
Registration and Continental Breakfast
9:00–9:05 AM
FDLI Welcome
Laura Brown, Director, Educational Programs, Food and Drug Law Institute
9:05–10:05 AM
DOJ, FDA, and Compliance in Criminal Violations of the FDCA (Oh My!)
Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
Shannon L. Pedersen, Senior Corporate Compliance Coordinator, Consumer Protection Branch, U.S. Department of Justice
Shannon M. Singleton, Assistant Deputy Chief Counsel for Litigation, Office of the Chief Counsel, FDA
Beth P. Weinman, Counsel, Ropes & Gray LLP
Moderated by Sonia W. Nath, Partner, Cooley LLP
Recently, DOJ announced the establishment of a dedicated group of attorneys who would be monitoring compliance with commitments made as part of Deferred Prosecution Agreements and Non-Prosecution Agreements. This new approach raises interesting questions about the roles of DOJ and FDA in reviewing and making determinations about compliance in the criminal arena, which also carry implications for FDA’s civil enforcement activities such as permanent injunctions and seizure actions that result in court-ordered resolutions. The panel will take a closer look at these compliance provisions, and the cases that underpinned them, to better understand the implications of these requirements, as well as how DOJ and FDA work together in these matters.
10:15–11:15 AM
Enforcement and Charging Theories Outside of the FDCA: A Theranos Case Study
Catherine K. Dick, Assistant Director, Consumer Protection Branch, U.S. Department of Justice
Gustav W. Eyler, Partner, Gibson, Dunn & Crutcher LLP
William F. Gould, Partner, Holland & Knight LLP and Co-Chair, FDLI Enforcement, Litigation, and Compliance Conference
The Theranos trials resulted in multiple convictions of the two most significant company executives. There are many lessons for our industry from these most-watched life science trials. Recent cases, including these, illustrate FDA’s and DOJ’s focus in holding company executives and employees accountable for compliance with all laws and regulations. This emphasis was also recently highlighted in DOJ’s September 2022 “Monaco Memo.” This panel will use the US v. Holmes and Balwani trials to consider recent trends in enforcement outside of the FDCA, including charging theories, impacts of parallel enforcement, and areas of risk for companies.
11:15–11:30 AM
Networking Break
11:30 AM–12:30 PM
Concurrent Breakout Sessions 4
- False Claims Act and Fraud-On-The-FDA Theory for Liability
Colin Huntley, Deputy Director, Commercial Litigation Branch, Civil Fraud, U.S. Department of Justice
Maya P. Florence, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
Kelsey Schaefer, Associate Chief Counsel for Enforcement, Office of the Chief Counsel, FDA
Moderated by Frederick R. Ball, Partner, Duane Morris LLP and Treasurer, FDLI Board of Directors
On June 3, 2022, the Civil Division of the Department of Justice filed a statement of interest in a relator’s action in the Southern District of Florida, arguing that “[c]onduct giving rise to regulatory violations can also give rise to [False Claims Act] liability.” Specifically, requesting “that the ruling not foreclose the possibility that, under certain circumstances, conduct giving rise to violations of the FDCA or FDA regulations could…provide a basis for FCA liability,” also known as “fraud on the FDA.” This Panel will discuss this theory of liability, DOJ’s focus in this area, the circuit split on fraud on the FDA claims, and how life sciences companies can mitigate enforcement risk.
- Inspections Post-COVID: The Use of Onsite Inspections, Remote Assessments, and Other Regulatory Tools
John (Jack) C. Garvey, Managing Partner, Compliance Architects LLC
Neil P. Di Spirito, Partner, Brown Rudnick LLP
Ami E. Simunovich, Executive Vice President, Chief Regulatory Officer, Becton Dickinson (BD)
Moderated by Kalah Auchincloss, Executive Vice President, Greenleaf Health, Inc.
FDA has employed numerous alternative tools with respect to inspections since the start of the COVID-19 pandemic — 704(a)(4) records request, remote interactive evaluations, remote regulatory assessments, MRA reliance, and others. Panelists will discuss how FDA intends to use these new tools even now that on-site inspections have resumed, the legal ramifications of remote inspection tools, and what it means for industry best practices.
- The Impact of Food Safety Outbreaks and Subsequent Product Shortages: A Case Study on Infant Formula
Kristen Klesh, Partner, Loeb & Loeb LLP
Mark Moorman, Director, Office of Food Safety, CFSAN, FDA
Jessica P. O’Connell, Partner, Covington and Burling LLP
The case of contaminated infant formula highlighted key issues in food safety outbreaks and subsequent response. The identification of unsanitary manufacturing conditions and the resulting product recall were delayed, and the outbreak led to product shortages and enforcement actions being taken against the manufacturer. This panel will use this incident as a case study to consider the impacts of GMP and compliance issues in food safety outbreaks, the impact on product shortages, and how FDA utilizes enforcement discretion. Speakers will also discuss the consent decree that came out of this case and what companies can learn about FDA’s priorities in food-related enforcement actions.
12:30–2:00 PM
Luncheon Address: Ninth Annual Eric M. Blumberg Memorial Lecture
Jennifer Zachary, Executive Vice President and General Counsel, Merck & Co., Inc.
2:00 PM
Conference Adjournment
