in-PharmaTechnologist assesses the scale of the challenge facing the FDA in effectively monitoring overseas facilities, using interactive graphics and textual analysis.
Despite its request for a 19 per cent funding boost in 2010 the US Food and Drug Administration (FDA) predicts that the number of foreign inspections will remain the same but import testing will increase significantly.
The agency is also working with its counterparts at the European Medicines Agency (EMEA) and Australia’s Therapeutic Goods Administration (TGA) to share the burden of international inspections.
Globalisation of pharmaceutical operations has significantly increased the pressures faced by regulators, with the bubble graph below illustrating the scale of the challenge.
This chart covers the top eight overseas countries for FDA registered drug, including veterinary, manufacturing facilities but excludes the numerous facilities in other nations around the world.
In an attempt to police this new, global manufacturing network the FDA increased overseas inspections over the past decade, as illustrated below, but the heparin scandal highlighted the agency’s weaknesses.
The latest figures, which are excluded from the graph as a breakdown by country was unavailable, show that there were 452 overseas inspections in 2008, with 566 anticipated for 2009 and 2010.
Although this is a significant improvement on the 220 that were inspected in 2002 it is still a small proportion of the total overseas facilities, which the US Government Accountability Office (GAO) estimates at over 3,000.
In addition, despite the steady increase in overseas inspections the number of warning letters issued to overseas establishments, mapped below, has remained low.
These factors suggest that creative solutions, such as the joint inspections and outsourcing, may be necessary.
This was acknowledged by Janet Woodcock, now director of the FDA's drug research division, who told Reuters: "It is very difficult to see how we could actually cover the entire globe.
"If you consider many of these other plants aren't really inspected at all, putting in some type of programme would be better than not covering them."