As the number of overseas clinical trials supported by US companies swells, the FDA cannot ensure patient safety in these studies, according to a report by the Department of Health and Human Services.
During the past decade the number of foreign researchers providing data to the FDA for new drug applications increased 1600%. The number of countries supplying patients for research required by the FDA also surged, from 28 in 1990 to 79 in 1999. Latin America and Eastern Europe, including Russia, account for much of the expansion.
Yet, the FDA's "lack of information about . . . human subjects protections . . . becomes increasingly problematic," concludes the report, issued by the DHHS's Office of Inspector General. While the FDA regularly inspects review boards in the United States, diplomatic concerns and insufficient funding and staffing prevent the agency from doing the same overseas.
And while the agency . . . [Full Text of this Article]
