US controversy over FDA inspections abroad

A debate over the capacity of the US Food and Drug Administration to inspect foreign drug manufacturing facilities has been sparked by Senator Charles Grassley (Republican, Iowa). The ranking member of the Senate Finance Committee, in a letter to the FDA's Commissioner, Andrew von Eschenbach, noted that the agency disproportionately prioritizes quality inspections to European countries, partly because of the resources generated by user fees from branded drugmakers. Conversely, the oversight of generic drug production sites is less systematic, despite the fact that some countries, such as China, have a growing share of the active ingredient export market and serious quality lapses (Marketletters passim).

Sen Grassley wrote: "since the beginning of [fiscal year] 2002, the FDA conducted approximately 1,379 inspections of foreign pharmaceutical facilities, often focused in countries with few reported quality concerns." He quoted a recent Government Accountability Office study which found that China, a country that the FDA estimates has 714 drug production sites for export to the USA, received only 13 agency inspections, the same number as the UK, which has 169 sites and considerably fewer quality control issues. Meanwhile, drugmakers in Switzerland (14 visits for 83 sites), Japan (15 out of 196), Germany (22 out of 199) and France (24 out of 162) were all more rigorously overseen by the US authority.

To make matters worse, the Washington Post claimed that the number of FDA quality inspections in China has actually decreased from 18 in 2004 to 11 last year, although the figures do not exactly correspond with the GAO data, which showed a fall over 2005 to 2007 from 21 to 13. The accuracy of the data was not helped by the GAO's finding that the "FDA does not know how many foreign establishments are subject to inspection."