Foreign inspection worries GAO

In the high-risk series, created in January 2009, the US Government Accountability Office (GAO) details public operations that are vulnerable or need to be overhauled. The US Food and Drug Administration (FDA) was the focus of one of 30 topics in the first list and remains in the series.

Responding to globalization. There are thousands of foreign drugmedical device establishments registered to market their products in the United States. FDA has opened offices overseas, but GAO found that whithese offices are engaging in activities to help ensure the safety of imported products, FDA has not yet developed a long-term workforce plan that could help address the offices’ potential staffing challenges and talso needed a set of performance goals and measures that can demonstrate the contribution of these offices to the long-term outcomesrelated to the regulation of imported products. While FDA inspects domestic drug establishments about once every 2.5 years, it would take FDA about 9 years to inspect all the drug establishments in its foreign inventory.Inconsistent with GAO’s 2008 recommendation that FDA inspect, at a comparable rate, those establishments that are identified as having the greatest public health risk potential, if they experience a manufacturing defect, regardless of whether they are a foreign or domestic establishment. FDA has acknowledged that conducting foreign inspections can pose unique challenges, such as limits on its ability to require foreign establishments to allow the agency to inspect their facilities, the large number and incompleteness of information on certain suppliers of ingredients to foreign establishments, and the expenses associated with conducting foreign inspections.