Concerns over US FDA inspection of foreign clinical trials raised by government report

The US Food and Drug Administration has been criticized for reviewing only a fraction of foreign drug trials, despite an increase in the number of pharmaceutical companies moving drug testing overseas - often to areas with lower standards - to reduce costs, according to a report released yesterday the US Inspector General for the Department of Health and Human Services.

'As sponsors increase the number of foreign clinical trials in support of FDA marketing applications, the agency's current method of using inspections to ensure human subject protections and data validity is becoming increasingly strained,' warned Inspector General Daniel Levinson.

He also found that the FDA was 16 times more likely to audit a domestic trial than a foreign one, which can cost as much as $40,000, and faulted the agency for sometimes having incomplete clinical trial records, encouraging it to adopt a standardized electronic format.