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Project January 17, 2011

Drug Companies Skirt FDA By Going Abroad

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A clinical trial consent form. Image by Kelly Hearn. Peru, 2010.
A clinical trial consent form. Image by Kelly Hearn. Peru, 2010.

Big drug companies are increasingly going overseas to test new drugs and devices on patients. That's because it is cheaper, regulations are not as onerous, patient recruitment is easier and informed consent is less defined. It's a good deal for the drug companies, but what about consumers?

A new report released by the Office of Inspector General at U.S. Health and Human Services notes critical shortcomings in the FDA's inspection record of foreign clinical trials.

Among the findings: 80 percent of the new drugs approved for sale in the United States in 2008 had trials conducted in foreign countries; 78 percent of all subjects who participated in clinical trials were enrolled at foreign sites, and 10 drugs were approved that did not have a single test subject from the U.S. Meanwhile, the FDA inspected only 0.7 percent of foreign clinical trial sites.

Journalist Kelly Hearn examines these regulatory shortcomings. His investigation focuses on South America, the region that accounted for 26 percent of all subjects enrolled at foreign trial sites, and in particular Peru, the country with the largest number of patients. He also looks at the implications for U.S. consumers.