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U.S. FDA to Open Regional Office in San José

January 9, 2009

The U.S. Food and Drug Administration  will open an office here to help make sure Latin American exports meet U.S. quality standards.

To better regulate exports from developing  countries, the FDA has also opened offices in Britain and China, and plans to open offices in India and the Middle East, said FDA commissioner Andrew von Eschenbach.

The San José office will open in about three months and have six staffers, including experts in veterinary health and food safety.

The FDA also plans to hire representatives in Honduras, Guatemala, Mexico and one or two countries in South America.

“This is the opening of a new era,” said Michael Leavitt, U.S. Secretary of Health and Human Services, who was in Costa Rica on Wednesday with Eschenbach. “In the past, we have stood at our borders and attempted to find things that were not safe or did not meet our quality standards.”

Now, the U.S. will work with exporters and government officials in other countries to make sure products meet FDA standards before they reach the U.S.

About $2 trillion worth of goods enter the U.S. annually from more than 150 countries, according to an FDA press release.

The FDA chose Costa Rica as a regional hub because the country has good infrastructure and a willing administration and recently entered the Central American Free-Trade Agreement with the United States (CAFTA), Leavitt said.

The FDA office here will work with exporters of produce, drugs and medical devices to make sure products meet U.S. standards. The office may also inspect manufacturing and processing facilities.

In the coming weeks, the FDA and Costa Rica’s Health Ministry will host a workshop on medical and ethical standards for clinical trials by drug companies, said Paul Seligman, who will head the office here.

A series of recent scares involving tainted products prompted the Bush administration to step up monitoring, Leavitt said.

 

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