The Justice Department (DOJ) is nearly a year into a major sweep of the pharmaceutical industry for Foreign Corrupt Practices Act (FCPA) violations. Although the investigation has been low-profile so far–no charges have yet been filed–the effort has the potential to change the way drug and medical device companies do business.
“This is a huge deal because of the number of clinical trials run abroad and the percentage of drugs that are approved in the U.S. that derive from those trials,” says Glen Donath, a partner at Katten Muchin Rosenman.
