Enforcement, Litigation, and Compliance Conference For the Pharmaceutical, Medical Device, Food, and Tobacco Industries
December 7-8, 2016 The Mayflower Hotel 1127 Connecticut Ave NW Washington, DC 20001 *Agenda subject to change
Wednesday, December 7
8:00 – 8:45 AM Registration and Continental Breakfast 8:45 – 8:50 AM Welcome and Opening Remarks
Amy Comstock Rick, President & CEO, Food and Drug Law Institute
8:50 – 9:20 AM Keynote Address
Benjamin C. Mizer, Principal Deputy Assistant Attorney General, Civil Division, Department of Justice
9:20 – 10:20 AM Compliance Central with FDA Center Compliance Directors: Part I
This two part session will address FDA’s top compliance issues, enforcement priorities, and goals for 2017. Hear directly from each FDA Center Compliance Director and learn how industry should focus their compliance efforts, and what really happens when you don’t follow FDA regulations.
Tom Cosgrove, Acting Director, Office of Compliance, Center for Drug Evaluation and Research, FDA Carl Fischer, Senior Advisor, Office of Compliance, Center for Devices and Radiological Health, FDA Mary Malarkey, Director, Office of Compliance and Biologics Quality, Center for Biologics and Evaluation Research, FDA Moderated by John R. Manthei, Partner, Latham & Watkins LLP
10:20 – 10:40 AM Networking Break 10:40 – 11:40 AM Compliance Central with FDA Center Compliance Directors: Part II
Daniel McChesney, Director, Office of Surveillance and Compliance, Center for Veterinary Medicine, FDA Michael W. Roosevelt, Deputy Director, Office of Compliance, Center for Food Safety and Nutrition, FDA Ann Simoneau, Director, Office of Compliance and Enforcement, Center for Tobacco Products, FDA Moderated by Miriam Guggenheim, Partner, Covington & Burling LLP
11:45 – 12:30 PM Concurrent Breakout Sessions in Your Industry
I. Food: Medical Foods: FDA’s Guidance, Substantiation Standards, and a Survey of Enforcement and Litigation Risk This panel will focus on issues raised by FDA’s guidance on medical foods, including First Amendment concerns. Speakers will also discuss substantiation standards for medical foods, recent FDA warning letters, and the risk of class action litigation in the medical foods space.
William A. Garvin, Partner, Buchanan, Ingersoll & Rooney PC Sarah Roller, Partner, Kelley Drye & Warren LLP Moderated by Brooke Schumm, President and Principal, Daneker, McIntire, Schumm, Prince, Manning & Widmann, P.C.
II. Drugs and Device: False Claims Act Enforcement Targeting Drug and Device Companies In June, the Supreme Court issued its opinion in Universal Health Services v. U.S. ex rel. Escobar, in which the Court affirmed the theory that violations of statutory and regulatory provisions can constitute actionable fraud under the False Claims Act. This panel will explore different views on how this decision might affect FCA investigations and litigation in the coming years, including whether the drug and device sectors can expect more cases based on violations of provisions of the Federal Food, Drug & Cosmetic Act.
Jonathan M. Phillips, Associate Attorney, Gibson, Dunn & Crutcher LLP Robert L. Vogel, Partner, Vogel, Slade, & Goldstein, LLP
12:30 – 1:45 PM Networking Luncheon with Roundtable Discussions 1:45 – 3:00 PM Concurrent Breakout Sessions Preparing for and Responding to FDA Enforcement Actions – Advanced Topics
I. Medical Products This session will focus on policies and practices that companies should consider in preparing for the possibility of FDA enforcement action. The objective is to ensure that companies understand their rights and take appropriate action in response to FDA investigations, as well as how to address the potential culpability and defense of individuals who may be the subject of FDA enforcement.
Michael Beatrice, Principal, Validant William F. Gould, Partner, Holland & Knight LLP Daniel A. Kracov, Partner, Arnold & Porter LLP Marta L. Villarraga, Principal, Exponent, Inc.
II. Food and Dietary Supplements This session will address a company’s roles, rights, and responsibilities in the event of an FDA inspection or enforcement action. Speakers will also explore potential FDA enforcement actions given the multitude of new rules, regulations, and guidances released this year; FDA’s renewed interest in misbranding issues; and how to push back if you think FDA is wrong.
Allison Fulton, Partner, Sidley Austin LLP Leslie T. Krasny, Partner, Keller and Heckman LLP Alan G. Minsk, Partner, Arnall Golden Gregory LLP Moderated by Stuart M. Pape, Shareholder, Polsinelli PC
3:00 – 3:20 PM Networking Break 3:20 – 4:20 PM Concurrent Breakout Sessions Hot Topics in Your Industry
I. Food: Consumer Class-Actions and FDA Regulated Products This panel will focus on topics such as: what products and claims are facing the greatest risk of class actions; follow-on litigation from FDA, FTC, and State AG enforcement actions, and strategies for reducing class action risk.
Jeffrey S. Jacobson, Partner, Kelley Drye & Warren LLP Glenn G. Lammi, Chief Counsel, Legal Studies Division, Washington Legal Foundation Yvonne M. McKenzie, Partner, Pepper Hamilton LLP
II. Drugs and Device: Warning Letters and Data Integrity Recently, FDA has been issuing warning letters with language related to data integrity that appears to go beyond what is described in the draft guidance. Does this create a new cGMP standard for data integrity? This session will delve into the recent warning letters to address the GMP issue and determine what lessons can be learned.
Frederick R. Ball, Partner, Duane Morris LLP Raj. D. Pai, Partner, Sidley Austin LLP Robert A. Rhoades, Senior Vice President, QuintilesIMS
III. Tobacco: Interactions between the Deeming Rule and FDA Enforcement FDA’s recently promulgated Deeming Regulations details FDA’s authority to regulate electronic nicotine delivery systems (ENDS), cigars, pipe tobacco, and a number of other tobacco products that have been brought under its jurisdiction. This panel will discuss what to expect from FDA compliance inspections—including retail, internet, and import inspections, along with specific enforcement options. Learn more abou t FDA’s Center for Tobacco Products’ educational efforts to provide industry with compliance training and assistance.
David Dobbins, Chief Operation Officer, Government Affairs, Truth Initiative Stacy Ehrlich, Partner, Kleinfield, Kaplan & Becker LLP
4:25 – 5:30 PM Navigating FDA Import and Export Processes and Related Enforcement
This session will provide an overview of the laws, standards, and processes associated with the import and export of FDA-regulated products, with a particular emphasis on enforcement trends and processes for challenging detentions, alerts, and other enforcement actions.
John F. Johnson, Senior Associate Attorney, FDAImports.com LLC and Benjamin L. England & Associates, LLC Douglas Stearn, Office of Enforcement and Import Operations, FDA Domenic Veneziano, Independent Advisor for Import Operations, EAS Consulting Group LLC
5:30 – 7:00 PM 2016 Annual Holiday & Leadership Awards Reception
Thursday, December 8
8:00 – 8:30 AM Registration and Continental Breakfast 8:30 AM FDLI Welcome and Remarks 8:30 – 9:30 AM ORA and FDA District Directors Forum
Find out how district directors evaluate and handle issues in their jurisdictions.
Steven B. Barber, Director, Cincinnati District Office, FDA Douglas Stearn, Office of Enforcement and Import Operations, FDA Jessica Zeller, ORA Ombudsman, Office of Regulatory Affairs, FDA Moderated by Steven Niedelman, Consultant, King & Spalding LLP
9:30 – 10:45 AM Strict Liability Based on FDA Violations: How to Protect Your Company and Yourself
In July of 2016, two former J&J medical device unit executives were convicted of introducing a misbranded device into interstate commerce. This verdict comes on the heels of the Eighth Circuit’s July 2016 opinion upholding jail sentences for officers of Quality Egg LLC, who pled guilty to FDCA violations in connection with the sale of contaminated eggs. These convictions stem from the Responsible Corporate Officer Doctrine – otherwise known as the Park doctrine – under which officers and executives of food and drug companies can be held liable for FDCA violations even where they had no personal knowledge of wrongdoing. This session will explore recent government successes in obtaining criminal convictions under these theories, what factors make prosecution attractive, and what steps the food and drug industry can take to mitigate risk. Panelists will also explore how the Yates Memo factors into government prosecutions.
Daniel G. Jarcho, Partner, Alston & Bird LLP Kevin B. Muhlendorf, Partner, Wiley Rein LLP Neil F. O’Flaherty, Partner, Baker & McKenzie LLP Moderated by Matthew T. Newcomer, Principal, Post & Schell, P.C.
10:45 – 11:00 AM Networking Break 11:00 – 12:00 PM Trends in Litigation
What are the most important cases and settlements of the past year that have stemmed from enforcement actions? Speakers will address cases in food, drugs, tobacco, and medical devices and how these cases set the tone for the future.
Adrienne Franco Busby, Partner, Faegre Baker Daniels LLP Christopher M. Mikson, Partner, Mayer Brown LLP Angela M. Spivey, Partner, McGuireWoods LLP
12:05 – 1:00 PM Concurrent Breakout Sessions
I. Understanding and Responding to a State AG Inquiry or Investigation A State Attorney General has a concern about a product you are selling or a claim you are making—will an AG file litigation or issue a subpoena right out of the gate? Likely not, but whether by phone, letter, or service of a Civil Investigative Demand (CID), an AG inquiry is concerning for a company. This session will address how to effectively respond to an AG inquiry no matter its form, define AG powers and authority, and how to avoid an inquiry in the first place.
Doreen L. Manchester, Counsel, Venable LLP Ellyn L. Sternfield, Of Counsel, Mintz Levin Cohn Ferris Glovsky and Popeo PC Philip Ziperman, Consumer Protection Director, Office of Attorney General for the District of Columbia
II. Limiting the Risk of Enforcement Actions following Acquisitions or Mergers Many FDA enforcement actions stem from legacy systems and products acquired during mergers and acquisitions, such as via inadequate verification or validation activities. Adequate due diligence activities are crucial for the proper valuation of target companies and products, as well as to identify immediate compliance risks and avoid post-closure surprises. This session will address these issues and more, to ensure that acquired products meet the company’s and FDA standards, avoid FDA enforcement action, and mitigate litigation risk.
Neil P. DiSpirito, Of Counsel, Ballard Spahr LLP Sandra C. Kalter, Vice President and Chief Regulatory Counsel, Medtronic Natasha Leskovsek, Partner, Cooley LLP Moderated by Danielle C. Humphrey, Senior Associate, Hogan Lovells LLP
1:00 – 2:00 PM Luncheon Address: Fourth Annual Eric M. Blumberg Memorial Lecture
John R. Fleder, Director, Hyman, Phelps & McNamara, P.C.
Introduced by Jennifer Bragg, Partner, Skadden, Arps, Slate, Meagher, & Flom LLP, and Member, FDLI Board of Directors
2:00 PM Conference Adjournment