The increasing reliance on foreign clinical trials for testing new drugs has led to concerns about the ability of the US Food and Drug Administration (FDA) to monitor such research, according to a US government report.
The report, issued June 22 by the US Department of Health and Human Services' Office of Inspector General (OIG), noted that in fiscal year 2008, 80% of marketing applications for drugs and biologics approved for US use contained data from foreign clinical trials, and more than half of clinical trial participants and sites were located outside of the country. But the OIG found that the FDA was able to inspect only 0.7% of such trial locations, compared with 1.9% of domestic clinical trial sites (http://oig.hhs.gov/oei/reports/oei-01-08-00510.pdf). The OIG also reported that reliance on foreign trials by pharmaceutical interests appears likely to increase.
Mike Mitka. As Use of Foreign Drug Trials Grows, FDA Oversight May Not Be Keeping Up. JAMA. 2010;304(8):843–844. doi:10.1001/jama.2010.1194