The Pharmalot blog reports that the GAO had critical words to share with the FDA with regard to its implementation of GAO recommendations for inspections of foreign drug manufacturing sites. The GAO stated there is an urgent need for the FDA to do better.
Specifically, despite a funding increase from $12 M to $41 M to promote inspections, only 11 percent of targeted foreign inspections were done in 2009 - thus it would take 9 years to inspect everyone targeted by the FDA. By contrast, the FDA is inspecting all 1015 US facilities on its list in about 2.5 years. The FDA database contains 3765 foreign facilities but 2394 have never been inspected - most in China and India. The former country has certainly been a hotspot for raw material adulteration/contamination issues related to the manufacture of drugs in recent years.
The GAO also criticizes FDA for prioritizing inspections around new facilities listed on applications versus inspecting commercial facilties with known problems. The GAO recommends that the FDA inspect foreign establishments at a frequency comparable to domestic sites with similar characteristics. The agency must concentrate its resources on those facilities that pose the greatest risk to the public health shoudl they exhibit a manufacturing defect.
Posted by Bruce Lehr November 1st 2010.