Daniel Levinson, inspector general for the Department of Health and Human Services, has found that 80% of American drugs approved for sale in 2008 had clinical trials in foreign countries. Furthermore, 78% of all test subjects were enrolled at foreign sites, and at least 10 medicines approved by the Food and Drug Administration in 2008 were tested entirely abroad without the participation of a single U.S. patient.

 

The use of foreign populations for American clinical trials has been criticized by medical ethicists who worry that patients may not receive proper protection in countries with lax regulations.

 

Levinson did discover that most foreign clinical trials and test subjects were in Western Europe, “where ethical controls over research are generally as robust as those in the United States,” wrote The New York Times. But 26% of all test subjects used in 2008 were from Central or South America.

 

That same year, the FDA’s inspection rate for foreign clinical sites was less than half that of domestic facilities. In fact, FDA investigators were 16 times more likely to audit a domestic site than a foreign one.

-Dvid Wallechinsky

 

Concern Over Foreign Trials for Drugs Sold in U.S. (by Gardiner Harris, New York Times)