In fiscal 2009 the US Food and Drug Administration (FDA) had an estimated inventory of 920 drug facilities in China, of which 811 may never have inspected by the agency. Furthermore, 64 per cent of all 3,765 foreign sites in the inventory may never have been inspected by the FDA.
The US Government Accountability Office (GAO) presented these figures in its report evaluating progress made since its 2008 assessment of overseas inspections by the FDA. In its latest report the GAO concludes the FDA has implemented some improvements but more progress is needed.
Given the long-standing nature of overseas inspections challenges, and reliance on foreign production, “there is an urgent need for FDA to better protect the public health by implementing our prior recommendations”, writes the GAO.
Increasing overseas inspections
Although the FDA has increased overseas inspections, up year-on-year from 324 to 424, most activity still occurs in the US. If the FDA adhered to 2009 inspection rates it would take nine years to visit all overseas sites in its inventory, compared to two and a half years for domestic facilities.
However, the figure of nine years hides significant variability between countries. In 2009 the FDA inspected 52 of the 920 Chinese facilities in its inventory. At this rate it would take the agency 18 years to inspect every site once.
According to the GAO report, FDA officials believe without significantly increased inspectional capacity it is highly unlikely overseas and domestic inspection rates can be made comparable.
Furthermore, the FDA indicated it “cannot respond to the nation’s increasing reliance on the globalisation of the drug supply chain, in which manufacturing steps may be outsourced to multiple foreign establishments, at its expected fiscal year 2011 funding level”.
Selecting sites
In 2008 the GAO recommended the FDA inspects sites based on the public health risk a manufacturing defect at the facility would cause. However, foreign site inspection continues to occur in response to an establishment being listed on a new drug application (NDA).
Of the 424 foreign inspections performed by the FDA in fiscal 2009, 83 per cent were, at least in part, for preapproval. In contrast, 18 per cent of domestic inspections by the FDA included a preapproval element. The FDA says this approach to overseas inspections boosts efficiency.
However, the FDA still increased inspections of overseas sites on its priority list. In fiscal 2009, 88 high priority foreign sites were inspected from a list of 220, compared to 29 from a list of 104 in 2007.
In addition to the report into foreign inspections the GAO also published an assessment of overseas offices set up by the FDA. in-PharmaTechnologist will present further insights from both reports in upcoming articles.