KUDOS to FDLI’s Annual Enforcement, Litigation and Compliance Conference; For providing slides for those who can't attend the conference; keep checking back on website as more slides should be added

Tuesday, December 10

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

8:45 – 9:00 AM
Welcome and Opening Remarks

Susan C. Winckler, RPh, President & CEO, FDLI

9:00 – 9:30 AM
Keynote Address: HHS OIG's Prescription Drug Diversion Enforcement Efforts

Gary Cantrell, Deputy Inspector General for Investigations, Office of Inspector General, HHS

9:30 – 10:30 AM
Compliance Central with FDA Center Compliance Directors (Part I)
Attend Compliance Central to hear directly from FDA officials on compliance issues and goals for 2014.

Ilisa Bernstein, Deputy Director, Office of Compliance, CDER
Daniel McChesney, Director, Office of Surveillance and Compliance, CVM | Slides
Jennifer Thomas, Director, Division of Enforcement, Office of Compliance, CFSAN

Moderated by Lewis Grossman, Professor of Law, American University and Board Member, FDLI

10:30 – 11:00 AM
Networking Break

11:00 AM – 12:00 PM
Compliance Central with FDA Center Compliance Directors (Part II)

Mary A. Malarkey, Director, Office of Compliance and Biologics Quality, CBER | Slides
Steven D. Silverman, Director, Office of Compliance, CDRH | Slides
Ann L. Simoneau, Director, Office of Compliance and Enforcement, CTP | Slides

Moderated by Lewis Grossman, Professor of Law, American University and Board Member, FDLI

12:15 - 1:30 PM
Networking Lunch

1:30 – 3:00 PM
Concurrent Breakout Sessions: Responding to FDA Enforcement Actions

Session 1: Enforcement BasicsThis panel will cover “what to do when FDA shows up at your door.” Topics will include what to expect during an inspection, best practices for industry in managing the inspection while FDA is at the facility, FDA warning letters, recalls and the Park Doctrine and the role that 305 hearings play in enforcement proceedings.

J. Benneville (Ben) Haas, Partner, Latham & Watkins LLP | Slides
Joy J. Liu, Partner, Ropes & Gray LLP
Meredith Q. Olearchik, Associate Food Law Counsel, Campbell Soup Co. | Slides

Moderated by Jacqueline R. Berman, Associate, Morgan, Lewis & Bockius LLP


Session 2: Advanced ApplicationsThis panel will focus on a range of complex issues, including private enforcement actions through state consumer protection laws, the Lanham Act, False Claims Act, deferred prosecution agreements, and non-prosecution agreements. The session will present both the plaintiff and defense side of enforcement actions. Additionally, the panelists will review inspections and warning letters and what FDA enforcement trends may mean for industry members.

David J. Bloch, Principal Legal Counsel, Medtronic, Inc. | Slides
Mitchell S. Fuerst, Managing Partner, Fuerst Ittleman David & Joseph, PL | Slides
Stephen Gardner, Director of Litigation, Center for Science in the Public Interest | Slides

Moderated by John Fleder, Director, Hyman, Phelps & McNamara, P.C. | Slides

3:00 – 3:30 PM
Networking Break

3:30 – 4:30 PM
Hot Topics in Enforcement: Lessons Learned (Part I)

Bottomley Case – Lessons Learned in the Application of the Sentencing Guidelines and its Effect on Food and Medical Product StakeholdersUsing the Bottomley case as one example, this panel will discuss the penalties for counterfeit, unapproved, and mislabeled medical products. Beginning to a review of FDASIA, the Title 7 revisions, and sentencing guidelines, the panelists will then focus on specific enforcement actions and actions in the off-label context. The panel will wrap up with a brief commentary on what to expect next.

Joshua M. Davis, Partner, Arnold & Porter LLP | Slides
John Roth, Director, Office of Criminal Investigation, FDA


Pharmacy Compounding – Lessons Learned from the Interaction among the Executive, Legislative and Judicial BranchesThis panel will focus on the legislative intricacies of pharmacy compounding and related enforcement concerns. The session will also cover the challenges of bringing compounding pharmacies up to cGMPs, areas where FDA might bring more enforcement actions and FDA-based solutions to the problems associated with pharmacy compounding.

Rachael G. Pontikes, Partner, Duane Morris LLP
Sarah Sorscher, Attorney, Public Citizen | Slides

Moderated by Denise Smart, President, Smart Consulting Group LLC

4:30 – 5:30 PM
Hot Topics in Enforcement: Lessons Learned (Part II)

Food Importation – Lessons Learned from Recent Food Importation Alerts, Proposed FSMA Regulations, and other Importation Actions
This panel will cover four main topics:

• Use of foreign inspections and import alerts based on GMPs; 
• Rule modification and how it will impact companies moving forward; 
• Third party accreditation; and 
• Intentional adulteration. 

Lucinda J. Bach, Partner, DLA Piper US LLP | Slides
Gale Prince, President, Sage Food Safety Consultants


Privacy Issues – Lessons Learned from Mobile Medical Apps and other Emerging Technology 
In this session, panelists will use a hypothetical mobile app to highlight the differences between older and newer smartphones, show how hackers can reverse engineer to extract information and discuss other potential disclosure issues. The session will also cover where mobile medical apps currently stand in light of the new guidance and how law firms can help companies move through the approval process for mobile apps.

Mary L. Gerdes, Senior Counsel, BD
Robert J. Hudock, Member, Epstein, Becker & Green, P.C.

Moderated by Marta Villarraga, PhD, Principal, Exponent, Inc.

5:30 – 7:00 PM
2013 Annual Holiday and Leadership Awards Reception

Wednesday, December 11

8:15 – 9:00 AM
Continental Breakfast

9:00 – 10:30 AM
Interagency Enforcement Action: An Inside Look
Even the most veteran enforcement professionals are not always privy to how the federal government works across agencies to collaborate on enforcement actions. This panel will provide a unique first-hand perspective from agency officials across the federal government on how they communicate, collaborate, and implement enforcement actions.

Jarilyn Dupont, Director of Regulatory Policy, Office of Policy, OC, FDA | Slides
Jill Furman, Deputy Director, Consumer Protection Branch, DOJ
Robert L. Hill, Executive Assistant, Office of Diversion Control, DEA | Slides
Dora Hughes,Senior Policy Advisor, Sidley Austin LLP; former Counselor for Science and Public Health to Secretary Kathleen Sebelius
Mary E. Riordan, Senior Counsel, Office of Counsel, Office of the Inspector General, HHS
Beth P. Weinman, Associate Chief Counsel for Enforcement, Food & Drug Division, HHS Office of the General Counsel

Moderated by Eugene M. Thirolf, Consultant

10:30 – 10:45 AM
Networking Break

10:45 a.m. – 12:15 PM
Criminal and Civil Enforcement: Domestic and International Developments
In our ever-increasing global atmosphere, more companies need to be concerned with criminal and civil enforcement matters in the domestic and international arenas. This session will touch on the largest criminal and civil concerns, including foreign inspections, criminal and civil judicial enforcement activity, and cGMP violations.

Cathy L. Burgess, Partner, Alston & Bird LLP | Slides
Steven M. Kowal, Partner, K&L Gates LLP
Jessica L. Tillipman, Assistant Dean for Field Placement and Professorial Lecturer in Law, The George Washington University Law School | Slides
Will Woodlee, Associate, Kleinfeld, Kaplan, & Becker LLP

Moderated by Sonali P. Gunawardhana, Of Counsel, Wiley Rein LLP | Slides

12:15 – 1:30 PM
Luncheon Address: Inaugural Eric M. Blumberg Memorial Lecture

Annamarie Kempic, Deputy Chief Counsel for Litigation, Office of Chief Counsel, FDA

Introduced by Frederick H. Degnan, Partner, King & Spalding LLP

1:30 – 3:00 PM
Concurrent Breakout Sessions: Sleepless Nights

Session 1: Legal Issues Keeping Compliance Officers up at Night
This panel will focus on an array of pressing legal issues that compliance officers deal with on a daily basis. Some of the main topics include, the Sunshine Act, how to respond when a problem is linked to your product, and the best ways to get through to your employees.

Sarah diFrancesca, Associate, Cooley LLP | Slides
Leslie T. Krasny, Partner, Keller and Heckman LLP and Board Member, FDLI | Slides
Gary C. Messplay, Partner and Co-Chair of Food and Drug Practice at Hunton & Williams LLP; formerly Global Regulatory and Compliance Counsel, Eli Lilly and Company
Moderated by Nancy Singer, President, Compliance-Alliance, LLC

Session 2: Legal Issues Keeping In-House Counsel up at Night
While our panelists, leaders in their respective industries, do not worry much over things that go bump in the night, they are acutely cognizant of the significant legal issues evolving in the dynamic fields in which they practice and the specialized operations of their companies. Join our panel as we explore the mind-tugging thoughts that pervade the evening’s tranquility for in-house counsel.

John E. Kelly, Member, Bass, Berry & Sims, PLC
Caryn McDowell, Associate General Counsel, Head of US Healthcare Law, Onyx Pharmaceuticals
Sanjay Narayan, Senior Counsel, Regulatory, Compliance & Marketing, AbbVie
Matthew L. Stennes, Principal Litigation Counsel, Government & International Investigations, Medtronic, Inc.

  Moderated by Heather M. O’Shea, Partner, Jones Day

3:00 – 3:15 PM
Networking Break

3:15 – 4:30 PM
Litigation and Settlements: What You Really Need to Know
This panel will examine:

• Recent enforcement developments involving foreign pharmaceutical manufacturing and the impact going forward, particularly the government’s actions against Ranbaxy and other recent FDA actions; 
• FDA’s increasing sensitivity to drug, biologic, and medical device shortages in bringing enforcement actions and employing the agency’s enforcement discretion, specifically addressing Ben Venue Laboratories consent decree and the DC Circuit FDA v. Cook decision; and 
• Center for Food Safety v. Hamburg, as a case study in which FDA is the defendant and there is a tension between the agency’s statutory obligation to develop comprehensive food safety requirements and the agency’s obligation to promulgate the requirements promptly (by complying with statutory deadlines).

Reuben Guttman, Director, Grant & Eisenhofer PC | Article
Daniel G. Jarcho, Partner, McKenna Long & Aldridge LLP | Slides
James R. Johnson, Associate, Hogan Lovells US LLP
Jennifer Zachary, Partner, Covington & Burling

Moderated by Barbara A. Binzak Blumenfeld, PhD, Counsel, Buchanan Ingersoll & Rooney PC and Board Member, FDLI

4:30 PM
Adjournment

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