Agenda | Materials

subject to change

Wednesday, December 12

8:00–8:45 AM                
Registration and Continental Breakfast

8:45–9:00 AM
Welcome and Opening Remarks
Amy Comstock Rick, President & CEO, Food and Drug Law Institute
George M. Karavetsos, Partner, DLA Piper LLP and Chair, FDLI Enforcement, Litigation, and Compliance Conference

9:00–9:25 AM                 
Keynote Address
Scott Gottlieb, Commissioner of Food and Drugs, FDA

9:25–10:35 AM              
Compliance Central with FDA Center Compliance Directors: Part I | Speakers Slides
This two-part session will address FDA’s top compliance issues, enforcement priorities, and goals for 2019. 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.

Donald Ashley, Director, Office of Compliance, Center for Drug Evaluation and Research, FDA
William H. Maisel, Director, Office of Device Evaluation and Acting Director, Office of Compliance, Center for Devices and Radiological Health, FDA
Melissa Mendoza, Deputy Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, FDA
Ellen F. Morrison, Assistant Commissioner for Medical Products and Tobacco Operations, Office of Regulatory Affairs, FDA
Moderated by Deborah M. Autor, SVP/Head of Strategic Global Quality & Regulatory Policy, Mylan Pharmaceuticals, Inc.

10:35–10:50 AM            
Coffee and Networking Break                                            

10:50 AM–12:00 PM            
Compliance Central with FDA Center Compliance Directors: Part II | Speakers Slides

Eric M. Nelson, Director, Division of Compliance, Center for Veterinary Medicine, FDA
Michael W. Roosevelt, Deputy Director, Office of Compliance, Center for Food Safety and Applied Nutrition, FDA
Michael C. Rogers, Assistant Commissioner for Human and Animal Food Operations, Office of Regulatory Affairs, FDA 
Ann L. Simoneau
, Director, Office of Compliance and Enforcement, Center for Tobacco Products, FDA
Moderated by John R. Manthei, Partner, Latham & Watkins LLP

12:00–1:15 PM            
Luncheon Address | Speakers Slides
Stacy Cline Amin
, Chief Counsel, FDA
Introduced by Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Vice Chair, FDLI Board of Directors

1:15–2:10 PM                 
Concurrent Sessions: 

  • Delaying, Denying, Limiting, or Refusing Inspections: How to Prepare | Speakers Slides
    In this session, speakers will discuss new developments and how FDA’s authority has been used when an establishment delays, denies, limits, or refuses an inspection. Speakers will delve into how to raise legitimate questions about FDA requests for information, as well as how to effectively say no. The recent extension of FDA’s authority to devices and implications for foreign inspections will also be addressed.

    Daniel G. Jarcho, Partner, Alston & Bird LLP
    Paula Katz, Special Counsel, Covington & Burling LLP
    Deborah Tolomeo, Senior Advisor, Global Quality and Compliance, Genentech, Inc.
    Moderated by William A. McConagha, Partner, Sidley Austin LLP

  • Looking Forward: OTC Drug Compliance | Speakers Slides
    What is FTC’s current thinking on homeopathic drugs? Will the trend of increasing GMP oversight for foreign and domestic OTC drug manufacturers continue? What questions are OTC drug clients asking their lawyers? How will the new legislation for OTC drugs that might be enacted affect FDA’s enforcement policies? Panelists will tackle these questions and more during this session.

    Richard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, Federal Trade Commission
    Francis Godwin, Acting Director, Office of Manufacturing Quality, Center for Drug Evaluation and Research, FDA
    Christine E. Kirk, Associate, Arnall Golden Gregory LLP
    Moderated by David J. Horowitz, Partner, Hogan Lovells US LLP

  • Consumer Fraud Cases in Food and Drugs
    One of the original goals of the FDCA was to protect consumers from fraud. Recently, we are seeing the agency think about fraud more. In what ways are we seeing the government use this function, for example in consumer confusion cases? What types of claims are sticking? This panel will explore FDA’s authority and actions in this area, as well as look to other statutes and agencies that are also active in protecting consumers from fraud.

    August T. Horvath
    , Partner, Foley Hoag LLP
    John F. Johnson
    , Senior Associate Attorney, LLC / Benjamin L. England & Associates LLC
    Megan L. Olsen, Assistant General Counsel, Council for Responsible Nutrition

2:10–2:15 PM

2:15–3:10 PM                 
Concurrent Breakout Sessions:

  • The Benefits and Risks of Internal Audits and Investigations | Speakers Slides
    In many of its warning letters, the Food and Drug Administration calls on firms to use independent technical consultants to remediate compliance problems. Often, internal investigations produce reports that in part that assess the scope of problems and recommend possible solutions. What information as part of that audit is required, or not required, to be turned over to FDA? What are the pros and cons of having a privileged investigation vs. having a consultant? The impact on consent decrees and use of independent experts will also be addressed.

    Thomas J. Cosgrove
    , Partner, Covington & Burling LLP
    John Geissler, Global Head, Compliance, Incident Management and Audit, Novartis
    Frances M. Zipp
    , President & CEO, Lachman Consultant Services, Inc.
    Moderated by Howard R. Sklamberg, Partner, Akin Gump Strauss Hauer & Feld LLP

  • Emerging Trends in State and Federal Opioid Investigations and Prosecutions | Speakers Slides
    The opioid epidemic has ignited a firestorm of actions and reactions, by government and private actors alike. Federal and state governments have filed lawsuits against actors in the drug supply chain and qui tam whistleblowers in the private sector. This presentation will provide an overview of a variety of regulatory and enforcement actions taken by various public and private actors in response to the opioid epidemic, and what all stakeholders in the drug supply chain need to know given the recent passage of the opioid legislation.

    Jill Furman
    , Deputy Director, Consumer Protection Branch, US Department of Justice
    George M. Karavetsos, Partner, DLA Piper LLP and Chair, FDLI Enforcement, Litigation, and Compliance Conference
    Kerry Mannion, Special Agent in Charge, Office of Criminal Investigations, FDA
    Thomas W. South, Deputy Assistant IG for Investigations, Office of the Inspector General, US Office of Personnel Management
    Moderated by Jonathan E. Levitt, Co-Founding Partner; Attorney, Frier & Levitt

  • Unique Compliance and Enforcement Issues with Cell and Gene Therapies | Speakers Slides
    In the last year, FDA has approved several novel gene therapy products, including the first chimeric antigen receptor (CAR) T cell therapy. The agency also published a suite of guidance documents related to cell and gene therapy in July 2018 and several on regenerative medicine in the fall of 2017. This panel will take a legal and regulatory look at the questions surrounding how to maintain robust quality during manufacturing and how FDA can effectively maintain appropriate oversight without discouraging innovation as more complex cell and gene therapy products are approved.

    Barbara A. Binzak Blumenfeld, Shareholder, Buchanan Ingersoll & Rooney PC
    Areta Kupchyk
    , Partner, Foley Hoag LLP
    Mark Levi
    , Senior Consultant, RCS Regulatory, Parexel International
    Moderated by 
    Kalah Auchincloss, Senior Vice President, Regulatory Compliance, and Deputy General Counsel, Greenleaf Health, Inc.

3:10–3:30 PM                 
Coffee and Networking Break

3:30–4:30 PM                 
Imports and International Considerations: Enforcement Trends and Updates | Speakers Slides
As business and manufacturing becomes increasingly global in nature, so do enforcement and compliance issues. During this panel, speakers will address a variety of top-of-mind international considerations and concerns. Topics include: FDA’s approach to imports and it’s review strategies; mutual reliance initiatives; the difficulties of importing from the manufacturer perspective; and updates on FDA’s FSVP and VQIP programs for food products.

Kimberly Trautman, Executive Vice President, Medical Device International Services, NSF International
Domenic Veneziano, Capt USPHS (Retired), Principal, Veneziano Consulting, LLC
John Verbeten, Director, Division of Import Operations, Office of Regulatory Affairs, FDA
Moderated by Robert Guzman, Counsel, Thompson Hine LLP

4:30–5:30 PM
Top FDA Enforcement Cases in 2018 | Speakers Slides
This session will consider the top enforcement cases that have come down in the past year and the potential implications for industry. Consequences of FDCA violations, big dollar settlements, and areas of enforcement to keep an eye on for the future will be discussed.

William F. Gould, Partner, Holland & Knight LLP
Pete Leininger, Counsel, King & Spalding LLP
Jeffrey Steger, Senior Counsel for Complex Litigation, Consumer Protection Branch, US Department of Justice
Moderated by Anne Walsh, Director, Hyman, Phelps & McNamara, PC

5:30–7:30 PM                 
FDLI 2018 Annual Holiday Reception

Thursday, December 13

8:30–8:55 AM                
Registration and Continental Breakfast

8:55–9:00 AM                 
FDLI Welcome and Remarks
Laura Brown, Director, Educational Programs, Food and Drug Law Institute

9:00–9:45 AM                
Keynote Address
James Burnham, Deputy Assistant Attorney General, Civil Division, Consumer Protection Branch, US Department of Justice

9:45–10:45 AM              
What are the DOJ Enforcement Trends Regarding FDA-Regulated Companies?
While DOJ has frequently said it will continue to go after fraud in the healthcare space, do recent memos and policy positions give FDA-regulated companies additional breathing room from the sorts of white-collar fraud actions that have previously loomed large? For example, what does the Brand Memo  which indicates that the government will not rely on agency guidance as the basis for enforcement  mean for allegations related to misbranding? What about the policy against “piling on” to prevent duplicative penalties? This panel will discuss recent enforcement trends and policy pronouncements, and possible implications and key takeaways for FDA-regulated companies.  

Lisa M. Dwyer, Partner, King & Spalding LLP
Gustav W. Eyler, Acting Director, Consumer Protection Branch, US Department of Justice
Brandon Moss, Associate, Wiley Rein LLP
Michele Sartori, Partner, Hogan Lovells US LLP
Moderated by Michael S. Blume, Partner, Venable LLP

10:45–11:00 AM            
Coffee and Networking Break

11:00–11:55 AM            
Concurrent Breakout Sessions:

  • Responding to Data Integrity Issues and Best Practices | Speakers Slides
    Data integrity continues to be a key focus of FDA inspection and enforcement activity, and collateral impacts from FDA enforcement are also increasing. Panelists will review best practices for responding to FDA data integrity inspection and enforcement findings and will briefly explore topics including: the relationship between Good Clinical Practice and data integrity, potential impacts to product approval from data integrity deficiencies, working with contract manufacturers, challenges for dietary supplement manufacturers, and data integrity challenges in litigation.
    Cathy L. Burgess, Partner, Alston & Bird LLP
    Douglas B. Farquhar, Director, Hyman, Phelps & McNamara, PC
    Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health, Inc.
    Moderated by John C. (Jack) Garvey, Principal/Chief Executive Officer, Compliance Architects LLC

  • REMS as an Enforcement Tool | Speakers Slides
    While FDA’s REMS authority has historically been touted as a measure to ensure the safe use of certain medications, FDA and DOJ have begun to use REMS compliance as an enforcement tool. In the past year, a company’s alleged non-compliance with REMS requirements as a theory of criminal misbranding, and two cases have been settled. This panel will discuss how REMS has been used as an enforcement tool and what companies can do to ensure they are complying with their obligations.

    Jennifer Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Vice Chair, FDLI Board of Directors
    Rachel Turow, Executive Counsel – Regulatory Law, Teva Pharmaceuticals USA, Inc.

  • Tobacco Enforcement Challenges and Recent Actions | Speakers Slides
    How does FDA monitor the marketplace and determine which products are legally marketed? What enforcement actions has FDA taken in this context? With the future implementation of product standards, such as the limit on NNN in smokeless tobacco products, nicotine limits in cigarettes, and a flavor ban or restriction, how will FDA effectively and efficiently enforce these standards? What will be the implications of such enforcement on the creation of a black market for non-compliant products?

    Tony Abboud
    , Executive Director, Vapor Technology Association
    Stacy l. Ehrich
    , Partner, Kleinfeld, Kaplan & Becker, LLP and Member, FDLI Board of Directors
    Beth G. Oliva, Partner, Fox Rothschild LLP

11:55–12:00 PM

12:00–1:00 PM              
Concurrent Breakout Sessions:

  • Managing a Recall: Preparing for Regulatory and Legal Implications | Speakers Slides
    Rarely a day goes by without a product recall notification, be it food with undeclared allergens, drugs with foreign materials, or devices that are mislabeled. This past year even saw FDA’s first ever mandatory recall under the Food Safety Modernization Act. Despite the expectation that companies prepare in advance for a potential recall, often companies are left flatfooted in addressing issues beyond those related to regulatory requirements. This session will recap regulatory obligations and anticipated interactions with FDA, as well as address handling of recall-related issues, such as recall publicity, insurance issues, and consequential litigation.

    Steven H. Armstrong
    , Independent Advisor, Food Law & Regulation, EAS Consulting Group, LLC
    Victoria Calhoon, Attorney, Faegre Baker Daniels LLP
    Matthew L. Jacobs, Of Counsel, Jones Day
    Mark Mansour, Partner, Foley Hoag LLP

  • False Claims Act Enforcement, Policy Updates, and Trends in Patient Support | Speakers Slides
    This panel will delve into recent False Claims Act (FCA) enforcement actions, which are often used to combat fraud and abuse in the healthcare space. Panelists will consider recent key cases and updates, including in the materiality standard, and whether companies can expect more FCA cases after Escobar. There has also been explosive attention in recent FCA enforcement surrounding reimbursement support activities by pharmaceutical manufacturers – panelists will discuss the unique risks associated with such activities, including best practices and compliance considerations for planning, implementing, and executing compliant reimbursement support activities and programs.

    Hannah Bornstein, Partner, Nixon Peabody LLP
    Abraham Gitterman, Associate, Arnold & Porter LLP
    Jonathan M. Phillips, Partner, Gibson, Dunn & Crutcher LLP

1:00–2:15 PM
Luncheon Address: Sixth Annual Eric M. Blumberg Memorial Lecture
Elizabeth H. Dickinson
, Senior Deputy Chief Counsel, Office of Chief Counsel, FDA
Introduced by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and Chair, FDLI Board of Directors

2:15 PM                           
Conference Adjournment