The Government Accountability Office’s latest assessment of FDA’s foreign drug inspections program takes the agency to task for failing to implement a new prioritization scheme that GAO recommended two years ago.

FDA has increased the number of foreign drug inspections – conducting 424 in fiscal 2009, compared with 333 and 324 in FY 2007 and 2008, respectively. However, its selection of foreign facilities for inspection is still largely driven by pre-approval purposes, rather than good manufacturing practice surveillance for marketed products.

In 2009, 17% of foreign facility inspections were for GMP-only purposes, while such inspections made up about 82% of domestic establishment visits.

This runs contrary to GAO’s recommendations in a 2008 report that urged FDA to inspect, at a comparable frequency, those establishments identified as having the greatest public health risk potential if they experience a manufacturing defect, regardless of whether they are foreign or domestic (Also see "FDA Ups Foreign Inspections In FY ’07; Visits 11% Of Foreign Establishments" - Pink Sheet, 27 October, 2008.).

In comments on the report, HHS said that if FDA were to conduct foreign GMP surveillance inspections at a rate comparable to that of domestic inspections, the frequency for both would be about once every seven years.

However, GAO noted its prior recommendation called for the same inspection frequency only for those foreign and domestic facilities with similar characteristics. The investigative agency asserted it was “urgent” that FDA adopt this approach.

FDA inspected 11% of foreign drug establishments in its inventory in 2009, compared with 40% of domestic establishments. The agency has begun a formal review to determine the appropriate inspection frequency for foreign and domestic facilities, GAO says.

Among the 424 foreign drug facility inspections performed in 2009, India and China accounted for the largest number of sites, with 59 and 52, respectively. Investigators assigned to FDA’s overseas offices in these countries conducted six of the inspections in total.

By Sue Sutter

GAO Chides FDA For Prioritizing Foreign Inspections Based On Pre-approval Concerns

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