In recent years, the pharmaceutical industry has been a frequent target of Foreign Corrupt Practices Act (FCPA) investigations. Since 2009, when Assistant Attorney General Lanny Breuer warned that the Department of Justice (DOJ) would be “intensely focused on rooting out foreign bribery in [the pharmaceutical] industry,” eight of the world’s 10-largest drugmakers have indicated that they may be facing FCPA liability, and many more have received letters of inquiry from DOJ. The government has paid particular attention to potentially improper payments associated with clinical trials conducted abroad. This article discusses recent developments in this arena and how pharmaceutical companies and medical device makers can best protect themselves from FCPA liability.
Sheila Mackay | Xerox Litigation Services
Pharmaceuticals is perhaps one of the industries where compliance with regulatory and industry standards, such as the privacy and security of personal information, matters most – in clinical trials, outsourcing, cross-border data transfers, anonymization and other areas.
Drug development, of course, is a risky business fraught with potential problems that can derail even the most well-organized campaigns. Companies are rightly fanatical about avoiding mistakes that could kill a development effort eight to 10 years in the making, with $2 billion in funding behind it.