FDLI’s Annual Enforcement, Litigation and Compliance Conference; Don’t Miss Hearing From HP&M and Key Government Officials!

December 6, 2013

The Food and Drug Law Institute (“FDLI”) will hold is annual – and quite popular – Enforcement, Litigation and Compliance Conference from December 10-11, 2013 at The Westin Georgetown in Washington, DC.  You can register for the conference here.  A copy of the conference agenda is available here.

During the two days of advanced sessions, attendees will hear HHS OIG’s deputy inspector general for investigations discuss prescription drug diversion enforcement efforts, hear compliance directors from all FDA product Centers discuss center-specific developments, and hear how the federal government works across agencies to collaborate on enforcement actions.  Here’s a list of the star-studded cast of government presenters:

  • Gary Cantrell, Deputy Inspector General for Investigations, Office of Inspector General, HHS
  • 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
  • Jill Furman, Deputy Director, Consumer Protection Branch, DOJ
  • Robert L. Hill, Executive Assistant, Office of Diversion Control, DEA, DOJ
  • Ilisa Bernstein, Deputy Director, Office of Compliance, CDER, FDA 
  • Jarilyn Dupont, Director of Regulatory Policy, Office of Policy, OC, FDA
  • Annamarie Kempic, Deputy Chief Counsel for Litigation, Office of Chief Counsel, FDA   
  • Mary A. Malarkey, Director, Office of Compliance and Biologics Quality, CBER, FDA 
  • Daniel McChesney, Director, Office of Surveillance and Compliance, CVM, FDA   
  • Michael W. Roosevelt, Deputy Director, Office of Compliance, CFSAN, FDA 
  • John Roth, Director, Office of Criminal Investigation, FDA
  • Steven D. Silverman, Director, Office of Compliance, CDRH, FDA 
  • Ann L. Simoneau, Director, Office of Compliance and Enforcement, CTP, FDA    

In addition to these key panels, attendees will hear from the FDA Office of Chief Counsel during the Inaugural Eric M. Blumberg Memorial Lecture.  (Mr. Blumberg, the Deputy Chief Counsel for Litigation at FDA, died last March of complications from a stroke – see here.)  

Hyman, Phelps & McNamara, P.C.’s John R. Fleder will moderate a panel on Responding to FDA Enforcement Actions.  The panel, which includes David J. Bloch, Principal Legal Counsel, Medtronic, Inc., Mitchell S. Fuerst, Managing Partner, Fuerst Ittleman David & Joseph, PL, and Stephen Gardner, Director of Litigation, Center for Science in the Public Interest, 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.

Categories: Enforcement