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Overseas offices will shorten inspection times during crises

By Nick Taylor , 04-Nov-2010
Last updated on 15-Sep-2011 at 14:13 GMT

Overseas offices will help the FDA schedule inspections more quickly in times of crisis but, as yet, employees based abroad have visited relatively few facilities.

Establishment of overseas offices was intended to improve US Food and Drug Administration (FDA) capacity to conduct inspections. Having opened the offices the FDA hopes to be able to respond more quickly to a crisis, according to the US Government Accountability Office (GAO).

To improve response times employees based overseas have strengthened relationships with foreign regulators. Using these relationships the FDA hopes to shorten timelines for scheduling inspections and sourcing information about problematic products in the event of a crisis.

For more routine inspections the FDA is already benefiting from having investigators overseas. Domestic-based investigators can face delays related to visas and other issues which can lead to inspections being conducted months after a site is notified.

In contrast, overseas-based investigators can conduct an inspection within weeks of notifying an establishment. FDA officials give the example of an India-based investigator conducting an inspection at short notice as part of the drug approval process.

However, these benefits are confined to India and China. The FDA has staffed its office in Shanghai, China with two investigators and sent three to work in Mumbai, India but none of the other offices house people capable of conducting medicinal product inspections.

A decision was made not to send investigators to the Latin American offices because the FDA believes it makes more economic and logistical sense to use domestic-based staff to cover the region.

Overseas staff conducted 24 inspections of drug producing facilities, nine in China and 15 in India, from the June 16 2009, the date of the first visit, to June 10 2010. This compares to 120 inspections, 38 in China and 82 in India, by domestic-based FDA employees in the same period.

FDA officials told the GAO there is no goal for how many inspections overseas investigators will conduct. It is trying to realise overall increases in India and China but conducted eight per cent fewer trials in the countries from June 2009 to June 2010 than the previous 12 month period.

Overseas investigators told the GAO they spend between 30 to 50 per cent of their time on inspections. Other tasks performed by overseas inspectors include supporting preliminary investigations, such as contacting facilities to verify information.

The FDA has also contracted external organisations to verify information, such as the existence of foreign registered sites. FDA officials said the initiative investigates suspect sites, such as one registered to import pickles and an active pharmaceutical ingredient (API) into the US.

Some FDA officials told the GAO they would like to see overseas offices play a more substantial role in inspection planning. For instance, overseas offices could assist with selecting establishments for inspection and support domestic-based investigators travelling abroad.

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