Cathy Burgess moderated the session "International Developments" at this conference sponsored by the Food and Drug Law Institute. 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 addressed 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.
- Expansion of Foreign Corrupt Practice Act (FCPA) investigations and liability.
- Compliance program approaches to avoid expanded jeopardy.
December 12-13, 2012