Sponsors Conducting Trials Abroad Should Be Cautious of FCPA

Sponsors conducting clinical trials outside the U.S. can expect increased scrutiny as the federal government looks to prosecute companies in violation of the Foreign Corrupt Practices Act (FCPA), according to Hank Walther, deputy chief of the Justice Department’s fraud section. Enforcing FCPA is going to be a priority for Justice, Walther said. FCPA is particularly a concern for trials conducted in parts of Asia and Europe, where staff at hospitals and academic institutions may be state employees, he said, adding that even basic expenses and routine payments to investigators may come under scrutiny in such cases.
Clinical Trials Advisor