The Burrill Report (June 28, 2010): FDA Faces Challenges Monitoring the Growing Number of Clinical Trials Conducted Overseas (.MP3,9.68 Mb)

A new report from the inspector general of the U.S. Department of Health and Human Services finds 80 percent of products approved by the U.S. Food and Drug Administration relied in part on foreign clinical trials. The report also found the agency inspected far fewer of these trial sites than trial sites in the United States and often didn’t even know about the trials until long after they were concluded. We spoke to Peter Pitts, president of the Center for Medicine in the Public Interest about the FDA’s oversight of these trials, the trends that are driving the growth in drug and device makers looking overseas for trial sites, and what steps should be taken to address the issue.