Agenda

Wednesday, December 12

7:30 – 8:15 a.m. 

Registration and Continental Breakfast 


8:15 – 8:30 a.m. 

Welcome and Opening Remarks 

Susan C. Winckler, President and CEO, FDLI

 

8:30 – 10:00 a.m. 

Keynote Address:  The New Faces of Enforcement

Michael S. Blume, Director, Consumer Protection Branch, U.S. Department of Justice
Gregory Demske, Chief Counsel to the Inspector General, U.S. Department of Health and Human Services, Office of Inspector General
Joseph Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, U.S. Drug Enforcement Administration
John Roth, Director, Office of Criminal Investigation, FDA

Moderated by Eugene M. Thirolf, Consultant


10:00- 10:30 a.m.

Networking Break


10:30 a.m. – 12:30 p.m.

Compliance Central with FDA Center Compliance Directors

  • CBER: Mary A. Malarkey, Director, Office of Compliance and Biologics Quality
  • CDER: Douglas Stearn, Deputy Director for Policy and Analysis, Office of Compliance
  • CDRH: Steven D. Silverman, Director, Office of Compliance
  • CFSAN: Michael W. Roosevelt, Deputy Director, Office of Compliance 
  • CTP: Ann L. Simoneau, RPh, Director, Office of Compliance and Enforcement
  • CVM: Martine L. Hartogensis, DVM, Deputy Director, Office of Surveillance and Compliance
Moderated by Raymond Bonner, Partner, Sidley Austin LLP

 

12:30 p.m. – 2:00 p.m.

Luncheon Keynote Address: Howard R. Sklamberg, Deputy Associate Commissioner for Regulatory Affairs, ORA, FDA


2:00 – 3:30 p.m. 

Concurrent Breakout Sessions: Responding to FDA Enforcement Actions

Enforcement Basics
In this session, experienced attorneys will discuss practical applications and strategies dealing with various FDA enforcement actions, including:

  • Addressing Form FDA 483 inspection observations
  • Responding to enforcement letters (Warning Letters and Notices of Violation) for promotional and manufacturing (cGMP and QSR) issues
  • Negotiating consent decrees
Kate C. Beardsley, Partner, Zuckerman Spaeder LLP
Kyle Sampson, Partner, Hunton & Williams LLP
Daniel G. Jarcho, Partner, McKenna Long & Alderidge LLP

Moderated by Philip Katz, Partner, Hogan Lovells LLP and Director, FDLI Board


Advanced Applications
In 2012, several key Congressional representatives,  a top FDA official, and Public Citizen have all urged the Department of Justice to prosecute more individuals and companies who may have violated the FDCA, both on criminal and civil matters. In this session, you will learn from experienced government and private bar attorneys, how FDA decides which matters to refer to DOJ, how DOJ chooses which referrals to go to court, what you should consider when deciding whether to negotiate a pre-filing resolution or to contest the government’s case in a trial, and what happens to you as you proceed through pre-trial and trial.

Jill Furman, Deputy Director, Consumer Protection Branch, U.S. Department of Justice
Christopher B. Mead, Attorney, London & Mead
Brien T. O’Connor, Partner, Ropes & Gray LLP

Moderated by Eugene M. Thirolf, Consultant

 

3:30 – 4:00 p.m.

Networking Break 

 

4:00 – 5:30 pm 

Hot Topics in Enforcement: 2012 Review, 2013 Preview 

  • The Second Circuit decision vacated the conviction of Alfred Caronia for promoting a drug for off-label use on First Amendment grounds. What happens next?
  • FDA’s increased use of Warning Letters to foreign manufacturers.
  • Recent public health scares and their impact on FDA’s regulation of pharmacy compounding
  • The impact of the Pom Wonderful case on the FTC’s expectations with regard to substantiation for advertising claims made by FDA-regulated companies
  • Trends in civil enforcement of the Controlled Substances Act regulatory provisions, including case examples.  

Harry J. Matz, Senior Trial Attorney, Narcotic and Dangerous Drug Section, U.S. Department of Justice
Douglas Stearn, Deputy Director for Policy and Analysis, Office of Compliance, CDER, FDA
Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP

Moderated by John R. Fleder, Director, Hyman, Phelps and McNamara, P.C.

 

5:30 p.m. – 7:00 pm.

2012 Annual Holiday and Leadership Awards Reception 

 



Thursday, December 13


8:00 – 8:30 a.m.

Continental Breakfast 

 

8:30 – 9:00 a.m.

State Enforcement Developments

William Clay Garrett, Lead Attorney/Assistant Attorney General, Medicaid Fraud Control Unit, Civil Investigations Squad, Virginia Attorney General's Office

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


9:00– 10:30 a.m.  

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 from FDA, DOJ, CMS, and OCI on how they communicate, collaborate and decide on enforcement actions.

Deborah Chasan-Sloan, Attorney, Office of General Counsel, Centers for Medicare & Medicaid Services
Ross Goldstein, Trial Attorney, Consumer Protection Branch, U.S. Department of Justice
Laura Pawloski, Senior Counsel, Office of Chief Counsel, FDA
John Roth, Director, Office of Criminal Investigation, FDA

Moderated by Stephen C. Payne, Partner, Gibson Dunn & Crutcher LLP

 

10:30 – 10:45 a.m. 

Networking Break 

 

10:45 a.m. – 12:00 p.m. 

Concurrent Breakout Sessions: Criminal and Civil Enforcement

Domestic Developments

The government's enforcement policies and directions dramatically affect and cause concerns for the companies and executives regulated by FDA. The investigation of off-label promotion, for example, has resulted in enormous monetary penalties assessed against medical products manufacturers. The federal government is now developing innovative penalties in both criminal and civil enforcement, including the forfeiture of intellectual property and the imposition of long term financial risk on individuals for compliance deficiencies. This panel will address the continued expansion of the government's enforcement program on these points:

  • Personal accountability under the Responsible Corporate Officer Doctrine and recoupment theories that impose long term financial risks.
  • Update on current or recent parallel civil products liability lawsuits and government enforcement actions.
  • Compliance program approaches to avoid expanded jeopardy.
Eric M. Blumberg, Deputy Counsel for Litigation, Office of Chief Counsel, FDA
Christiana P.  Jacxsens, Shareholder, Greenberg Traurig, LLP 
Matthew J. O'Connor, Partner, Covington and Burling LLP

Moderated by Steven M. Kowal, Partner, K&L Gates LLP


International Developments

As business within the life sciences field becomes increasing global, so too have the government’s enforcement actions. In this session, experts will discuss recent developments in international enforcement efforts and their challenges and experiences, including:

  • FDA’s new international focus and enforcement actions, such as the agency’s  recent collaboration with international bodies to take action against more than 4,000 international pharmacies.
  • International compliance tips from attorneys who have assisted life sciences clients on a global level, including recent FDA requirements regarding global GMP assessments.
  • The significance of the  recently released DOJ and SEC guidance on the application and enforcement of the U.S. Foreign Corrupt Practices Act for foreign medical product manufacturers.
Carmelo Rosa, PhD, Division Director, Division of International Drug Quality, CDER, FDA
Kathleen M. Sanzo, Partner, Morgan, Lewis & Bockius LLP
Jessica Tillipman, Assistant Dean for Field Placement and Professorial Lecturer in Law, The George Washington University Law School

Moderated by Cathy L. Burgess, Partner, Alston & Bird LLP

 

12:00 – 1:30 p.m.

Networking Lunch

 

1:30 – 2:30 p.m.

Litigation and Settlements: What You Really Need to Know
This panel will closely examine three very significant court decisions regarding FDA's enforcement powers and discretion, as well as a blockbuster settlement.

  • Beaty v. FDA.  The U.S. District Court for the District of Columbia ordered FDA to take action to prevent the importation of an unapproved drug used by states in the lethal injection executions.
  • Friedman v. Sebelius.  The U.S. Court of Appeals for the District of Columbia Circuit upheld the lengthy exclusion from federal healthcare programs of three pharmaceutical executives for convictions "related to fraud." The executives had pled guilty to misdemeanor misbranding charges under the Park "responsible corporate officer" doctrine, which imposes criminal liability on executives despite their lack of personal knowledge of the violative conduct.
  • NRDC v. FDA. The U.S. District Court for the Southern District of New York ordered FDA to initiate withdrawal proceedings for penicillin and two tetracyclines used at subtherapeutic levels in food- producing animals and also overturned the agency's denial of two petitions requesting withdrawal proceedings for the subtherapeutic use of a broader array of animal antibiotics.  
  • U.S. v. GlaxoSmithKline. In the largest health care fraud settlement ever, Glaxo agreed to pay $3 billion in combined criminal fines and civil damages for off-label promotion of various drugs.

Daniel A. Kracov, Partner, Arnold & Porter LLP
Neil H. MacBride, United States Attorney for the Eastern District of Virginia

Moderated by Reuben A. Guttman, Director, Grant & Eisenhofer P.A.

 

2:30 – 2:45 p.m.

Networking Break


2:45- 3:15 p.m.

"Quality by Design: Alternatives to Regulatory Enforcement Action for Critical Medical Product Manufacturing"

Zena G. Kaufman, Senior Vice President, Global Quality, Hospira, Inc.
Michael Levitt, Senior Director, Quintiles Consulting

Moderated by Cathy L. Burgess, Partner, Alston & Bird LLP


3:15 – 4:00 p.m.

Roundtable Discussion: Political, Social and Economic Factors Impacting Trends in Enforcement
Dynamic thought-leaders from government, industry, consulting and academia will discuss past, present and future policy positions on enforcement, compliance and litigation.

David Chesney, VP, PAREXEL International
Steven A. Grossman, President, HPS Group, LLC and Author, FDA Matters blog
Molly Muldoon, Vice President of Government Affairs, Onyx Pharmaceuticals

Moderated by William McConagha, Health Policy Advisor to The United States Senate Committee on Health, Education, Labor, and Pensions and former Associate Chief Counsel for Enforcement and Assistant Commissioner, FDA



4:00 p.m.


Adjournment