Heightened Scrutiny of Foreign Clinical Trials

On June 22, 2010, the US Department of Health and Human Services, Office of Inspector General (HHS-OIG) released a report critical of the US Food and Drug Administration's (FDA's) ability to monitor and inspect foreign clinical trials of drugs and biologics (the Report). The Report's conclusions regarding the extent of foreign trials underlying US applications garnered national media attention. While the Report did not identify any industry lapses in conducting foreign clinical trials or reporting data, the Report's findings are likely to heighten Congressional, FDA and US Department of Justice (DOJ) oversight and enforcement activity. This advisory addresses the risk of increased enforcement action and suggests measures to minimize those risks given that conducting foreign clinical trials is both appropriate and necessary in the global pharmaceutical market.