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FDA struggles with foreign inspections

Language and cultural issues hampering FDA overseas inspections - medical translationA couple of months ago, Eye on FDA had a good post about how translation issues are hampering FDA's inspections of overseas drug and device companies.

A lot of folks are concerned about this issue because it has the ability to negatively impact the safety of drugs and devices sold in the U.S. Two years ago, USA Today observed:

The United States still has the safest food and drug supply in the world, but the need for a new approach is necessitated by the dramatic changes in the nature of the food and drugs arriving in the USA from other countries. FDA processed 15 million shipments of goods in 2006, up 60% since 2003. Products arrived from more than 230 countries and more than 300,000 manufacturers. More and more drugs, especially generics, get their raw material from China and India, where local controls are weak. Against this, FDA has about 625 inspectors for foods and 260 for pill-type drugs.

And indeed, FDA faces a daunting challenge in its quest to improve the quality of imported drugs and devices. Resource shortfalls, outdated technologies, and surging international trade all contribute to the problem.

Last year, draft legislation has been put forward which would require FDA to inspect foreign manufacturing plants every four years. The bill also outlined the establishment of a permanent overseas inspection force. And FDA moved quickly: Over the past six months, the agency opened offices in China, India.

But the situation doesn't appear to have improved much. FDA inspectors are still ill-prepared for their overseas duties. Many do not understand the nation's culture as it applies to language and to business, let alone speak the country's language. While FDA is increasing its international presence, health care safety advocates are pushing for FDA to receive additional funding and resources, so that the agency can properly fulfill its mandate and avoid the public's distrust and concern about drugs and devices coming from emerging countries.

And that distrust is pretty wide-spread. Speaking about the legislation last year, Representative Dingell said: "For example, if it comes from Great Britain, you're going to assume it's pretty safe. If it comes from Canada, it's probably pretty safe. If it comes from China, you're going to say, 'Holy cats, we better watch out.'"

ForeignExchange Translations provides specialized medical translation services to the world's leading pharmaceutical and medical device companies.


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