Inspectors find US drug regulators face oversight challenge as drugmakers move testing abroad
Federal inspectors say the Food and Drug Administration is reviewing only a fraction of foreign drug trials, as companies increasingly move drug testing overseas to reduce costs.
A report by the Inspector General for the Department of Health and Human Services says the FDA inspected only about one percent of foreign drug testing sites in fiscal year 2008.
The agency is responsible for overseeing the safety of patients enrolled in studies by U.S. drugmakers.
However, the inspector found that the FDA was often unaware of early-stage trials conducted in developing countries in South and Central America.
The report recommends that the FDA coordinate better with foreign governments to monitor drug trials abroad.
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