Enforcement Trends and Public Policy: Lessons Learned and Practices to Follow

Track:
Public Policy/ Health Care Compliance/ Law

Day & Time:
June 26, 10:15AM - 11:45AM

Session Number:
338

Room Number:
154

Level:
Intermediate

Type:
Forum

Title:
Enforcement Trends and Public Policy: Lessons Learned and Practices to Follow

Chair(s):
Barry A. Berger, JD,MBA
Professor of Regulatory Affairs
Temple University, United States

Description:
In the context of recent compliance and enforcement trends, this forum will ask and answer such questions as: Should FDA and other government agencies place more of a priority on criminal enforcement? How has the Park doctrine and the Responsible Corporate Officer doctrine evolved, and is this good public policy? What is the significance of recent False Claims and Whistleblower lawsuits? What is the significance of the Foreign Corrupt Practices Act on our global industry? And, what can we learn from past government actions, and how should what we learn impact our future practices?

Learning Objective(s):
Discuss if there is a need for FDA or other government agencies to play more of an enforcement role; Discuss if the Responsible Corporate Officer doctrine represents good public policy; Identify what other enforcement actions have been and are being taken by regulators that impact industry and the public; Discuss recent False Claims and Whistleblower actions; Discuss the significance of the Foreign Corrupt Practices Act.

Presentation(s) & Speaker(s):
Panelist
Adolfo R. Garcia, JD
Partner
K&L Gates LLP, United States

Panelist
Susan G. Winkler
Assistant US Attorney
US Attorney's Office, District of Massachusetts, United States