Today the OIG posted “Challenges to FDA’s Ability To Monitor and Inspect Foreign Clinical Trials” (OEI-01-08-00510).
As all new investigational drugs and biologics must undergo clinical trials on human subjects to demonstrate safety and efficacy prior to approval for sale in the United States, pharmaceutical manufacturers sponsor trials involving investigators and patients both inside and outside the United States. The data in support of a particular product’s approval therefore comes from both U.S. and foreign clinical trials. The FDA, as mandated by the Food, Drug and Cosmetic Act is charged with the responsibility of ensuring the rights, safety and well-being of subjects who participate in these trials and of verifying that the clinical trial data collected are both accurate and reliable.
In the Report, the FDA found that 80 percent of approved marketing applications for drugs and biologics contained data from foreign clinical trials. Further, over half of clinical trial subjects and sites were located outside the United States. Astonishingly, the FDA inspected clinical investigators at less then 1 percent of foreign sites!