Processing Magazine

FDA Struggles to Track Foreign Drug Trials

June 23, 2010
A report by agency overseers reveals the Food and Drug Administration is reviewing only a fraction of foreign drug trials, as companies increasingly move drug testing overseas to reduce costs, according to the Associated Press. The FDA inspected about one percent of foreign drug testing sites in fiscal year 2008, according to a report issued by the Inspector General for the Department of Health and Human Services. The FDA is responsible for looking out for the safety of patients enrolled in studies of all drugs destined for the U.S. market. However, the inspector found that the FDA was often unaware of early-stage trials conducted in developing countries in South and Central America. Western Europe remains the largest venue for foreign testing, accounting for 58 percent of patients enrolled in foreign drug trials. But investigators found that countries in South and Central America had the largest numbers of patients per test site, suggesting drugmakers are eager to pack their test groups with patients from countries with lower operating costs. According to the HHS report, roughly 80 percent of drug approvals in fiscal 2008 were based in part on data from foreign studies. Eight percent of drug approvals contained only foreign data. The report makes a several recommendations to help the FDA oversee foreign studies, including better coordination with foreign governments to monitor drug trials abroad. Regulators should also require drugmakers to submit trial data in a standardized electronic format, to help the FDA identify sites for inspection, the report recommends.