This is Part II of a three-part series of the key takeaways from CBI’s 16th annual Pharmaceutical Compliance Congress was April 16th – April 18th.
Takeaway #2 – Expect a lot of uncertainty in how the government investigates and pursues criminal and civil allegations of wrongdoing.
The U.S Healthcare Fraud and Enforcement Panel featured two current Assistant U.S. Attorneys (AUSAs) and three former AUSAs currently representing pharma clients. Notably, the current AUSAs were very straight about how they source leads for investigations including whistleblowers, self-reporting, data mining, investigative reporting and public statements from pharma companies.
The former AUSAs were not shy about pushing back against, what they consider, the lack of consistent definition and enforcement of federal laws pertaining to the pharma industry. They pointed out that there is very little consistency between the different U.S. Attorney offices about what conduct constitutes a violation of pharma-related statutes. The current AUSAs said that if their offices believed it was a violation, they would pursue the case regardless of what other offices would do. This lack of consistent application of the law is a significant risk for the pharma industry, and it is easy to understand the frustration that pharma executives and counsel experience.
The DOJ encourages companies to self-report violations, and the DOJ will seek actions against individuals for personal liability. However, pharma companies question how much cooperation credit they will receive. There seems to be no consistent pattern of relief.
Part III will follow tomorrow.