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Published on 5 November 2007

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FDA to “revamp” foreign inspections

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The head of the the Food and Drug Administration has said he wants to revamp its import strategy in order to increase the number of inspections on foreign drug manufacturers.

He made the claim after a government watchdog told Congress that two-thirds of foreign drug manufacturers subject to inspection by the FDA may never have been visited by agency inspectors.

According to a Government Accountability Office (GAO) report, this year the FDA listed 3,249 foreign pharmaceutical  manufacturers which were subject to its inspections.

However, the report claimed that the agency cannot determine whether it has ever inspected 2,133 of them.

The report said that while some of the firms may never have exported prescription drugs or drug ingredients to the US, it is likely that others will have.

The report claims that the few foreign inspections the FDA does conduct in any given year hit just 7% of the foreign drug makers exporting to the US, adding that as a result, more than 13 years can pass before a foreign manufacturer is visited.

The FDA’s commissioner, Dr Andrew von Eschenbach, acknowledged the problems, but said the “solution to ensuring the quality of imports does not rely solely on increasing the number of inspections we conduct abroad – or even at the border.”

However, he added that in future FDA employees could be posted overseas, in order to boost the agency’s foreign presence.

Copyright © PA Business 2007

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