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FDA set for funding boost to grow foreign muscle

By Kirsty Barnes , 17-Jun-2008

The US Food and Drug Administration (FDA) is likely to receive a $275m budget boost to aid it in its ability to conduct foreign inspections.

The US government has amended its budget request for the FDA for fiscal year 2009, starting 1 October, after FDA commissioner Andrew von Eschenbach wrote to Pennsylvanian Senator Arlen Specter urging that that more funding was desperately needed in order to bolster the watchdog's offshore inspection capabilities and in doing so, improve the safety of the foreign food and drug supply chain. The proposed additional funding represents a 17.8 per cent jump on last year and is in addition to a 5.7 per cent increase already proposed by the government in February, which took the FDA's total budget for next year to $2.4bn. Announcing the news, US Health and Human Services Secretary Michael Leavitt told the media that the US government is starting to move from an "intervention strategy - where we stand at the border and try to catch things that are unsafe - to an integrated strategy of prevention with verification". On the pharmaceutical side of the agency's remit, $100m of the additional funding will be used by the FDA to add to its foreign operations, some of which will go towards to helping it "significantly expand" beyond US borders by establishing a presence in five new offshore destinations, including China and India, as well as helping ensure greater FDA compliance among the foreign drug manufacturers that supply their ingredients and products to the US. $50m has also been earmarked for use in preparing the FDA for "areas of emerging science" including nanotechnology and gene therapies, while the remaining $125m will be dedicated towards "protecting America's food supply". The FDA also plans to spend some of the extra cash on modernising its much criticised IT infrastructure, eventually allowing it to carry out over 1,000 additional inspections of foreign food and drug manufacturing facilities, as well as an extra 1,000 domestic inspections. The agency has been much criticised of late over its lack of oversight over the quality of the escalating number of food and drug imports reaching US shores, of which inadequate agency funding has been finger pointed by the FDA for much of the problem. The most recent high profile safety breach involving the watchdog was over a blood-thinning drug, heparin, being made offshore on behalf of Baxter and several other firms across the world. Production of the drug in multi-dose vials was suspended after heparin was linked to numerous deaths and over 350 reports of severe allergic reactions in the US. It subsequently emerged that some of the active pharmaceutical ingredient (API) for heparin was sourced from a plant in China, which the FDA had never inspected. The agency had apparently actually inspected the wrong facility instead, details of which were then entered into its database. Meanwhile, the Chinese drug authorities had never inspected the Chinese company involved either, as it was listed as a chemicals company and not a pharmaceutical company and was not registered with the agency as a heparin supplier. China's State Food and Drug Administration (SFDA) said that while it does enforce its own strict controls on the chemicals used in pharmaceuticals, "safeguarding the legality, quality and safety of active pharmaceutical ingredients (APIs)" is ultimately the responsibility of the importing country. With this being the case, the FDA has a mountainous task ahead and can undoubtedly use all the additional funding it can get, as China is a major supplier of foreign-made drug products entering the US.


The country's 714 drug-producing establishments made up 22 per cent of all foreign facilities eligible for FDA inspection in 2007. During the same period the agency only conducted 13 inspections in China, representing just 4 per cent of all inspections outside the US.

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