80 Percent of Drugs Sold in U.S. Use Foreign Trials

Medical ethicists are concerned about the growing share of new U.S. drugs whose human trials took place in foreign countries where federal auditors could not make sure patients were protected.

According to a report by Daniel R. Levinson, the inspector general of the Department of Health and Human Services, 80 percent of the drugs approved for sale in 2008 had trials in foreign countries. Ten medicines approved in 2008 were tested entirely abroad.

According to the New York Times:

“In 2008, the Food and Drug Administration inspected 1.9 percent of domestic clinical trial sites, while just 0.7 percent of foreign clinical trial sites were similarly audited. Mr. Levinson’s investigators found that the F.D.A. was 16 times more likely to audit a domestic site than a foreign one.”

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