FDA Should Improve Rate of Foreign Inspections

From fiscal year 2007 to 2009, the US Food and Drug Administration increased the number of foreign drug inspections it conducted, but the agency still conducted fewer foreign inspections than domestic inspections each year, according to a recent report by the US Government Accountability Office (GAO). In fiscal year 2009, FDA inspected 424 foreign sites, compared with 333 and 324 inspections in fiscal years 2007 and 2008, respectively. GAO estimated that in fiscal year 2009, FDA inspected 11% of sites on its list of foreign establishments, as opposed to approximately 40% of domestic establishments.

The rate at which FDA increased foreign drug inspections from fiscal year 2007 to fiscal year 2009 was higher than the rate at which FDA’s annual inventory of foreign drug establishments increased during the same period, according to the report. Still, the number of foreign establishments that the agency inspected in fiscal year 2009 remained a small portion of the total number of foreign establishments in FDA’s inventory. If FDA continued to conduct foreign inspections at the rate it achieved in fiscal year 2009, the agency would need about nine years to inspect each of the foreign establishments in its current inventory at least once, according to the report.

GAO noted that of the 3765 foreign establishments in FDA’s inventory for fiscal year 2009, 2394 foreign establishments (about 64%) may never have been inspected, an increase from the 2133 foreign establishments that may have never been inspected in fiscal year 2007. In comparison, 253 (about 10%) of the 2498 domestic establishments in FDA’s inventory for fiscal year 2009 may never have been inspected. The rate at which FDA inspected foreign facilities varied from country to country. FDA may not have inspected 88% of China’s 920 facilities, 64% of India’s 502 facilities, 48% of Japan’s 207 facilities, and 33% of Italy’s 168 facilities, according to the GAO report.

Although FDA mainly selected domestic establishments for inspection to monitor the manufacture of drugs already marketed in the US, the agency largely chose foreign establishments for inspection for preapproval purposes, according to GAO. In fiscal year 2009, 83% of foreign drug-establishment inspections contained preapproval components, compared with 18% of domestic drug-establishment inspections. Relatively few foreign establishments are selected for inspection solely to examine the manufacture of drugs already marketed in the US. FDA’s strategy of choosing foreign establishments for inspection therefore is inconsistent with GAO’s previous recommendations. “Specifically, we recommended that FDA inspect, at a comparable frequency, 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,” said the report.

GAO observed that FDA is trying to improve the information it receives from the drug establishment registration and import databases that it uses to manage its foreign drug inspection program. The agency is working to obtain more accurate information for its database dedicated to foreign establishments registered to market their drugs in the United States. FDA also is attempting to eliminate duplicate information from that database. Its efforts are in the early stages, however, according to the GAO report. FDA also is seeking to obtain better information about foreign drug establishments by methods such as collaborating with foreign regulatory authorities to exchange information about planned inspections and about the results of completed inspections.

In 2008, GAO recommended that FDA increase inspections of foreign drug establishments and improve the information it receives to manage the foreign drug inspection program. The current GAO report analyzes FDA’s progress in achieving these goals.