Foreign Trials Could Result in Sponsor FCPA Violations

Sponsors should reevaluate their conduct of foreign clinical trials in light of ongoing investigations into possible Foreign Corrupt Practices Act (FCPA) violations. Several drug and device companies — including Merck, SciClone, Baxter, AstraZeneca, Bristol-Myers Squibb and Lilly — have been contacted by the Justice Department and the SEC in a wide-ranging probe of industry payments to foreign officials. FCPA violations can include cash, gifts, meals, speaking fees or honoraria given to foreign officials in exchange for favorable actions on a drug or device.
Clinical Trials Advisor