With Congress launching an array of inquiries and calling for even greater scrutiny and federal and state enforcement activity at an all-time high, drug and medical device companies are now faced with operating in an unprecedented, headline-oriented climate. At a time when multi-million dollar fines and settlements are fast becoming a way of life, it has never been more critical for companies to ensure that their protocols and guidelines for conducting internal investigations utilize the best available practices to contain the significant risks involved. The American Conference Institute’s (ACI’s) 3rd National Conference on Internal Investigations for the Drug & Device Industries is tailored for pharmaceutical and medical device companies to benchmark the nuances and intricacies of their internal investigatory processes and response mechanisms to government inquiries.
On June 25, Foley Partner Daniel Reinberg will co-present “Recognizing Current Government Enforcement Trends.” Federal prosecutors and state AGs have been very active and aggressive in their investigations of pharmaceutical and medical device companies. Learning to recognize enforcement trends can teach you where to look for potential violations, as well as how to keep your house in order. In this session, experts will share their insights into what areas government investigators have been focusing their attention. Points of discussion will include an examination of the latest investigations including matters relating to:
- Fraud and abuse/kickbacks
- False Claims Act/Qui Tams, including Medicaid, Medicare, and potential Part D hot spots
- Off-label uses
- Educational activities
- Payments to consultants
- FCPA