FDA plan aims to increase import safety

June 20, 2011 By MATTHEW PERRONE , AP Health Writer

(AP) -- U.S. food and drug regulators would share more information with their foreign counterparts as part of a multifaceted strategy to police the safety of millions of imported goods.

A report issued Monday lays out plans to deal with a flood of imports to the U.S., which have quadrupled over the past decade.

The FDA's plan recycles ideas that have been circulated by FDA officials for more than a decade: computerize systems for tracking imports and collaborate more closely with regulators in developing countries.

The FDA report paints a daunting picture for regulators tasked with assuring the safety of most foods, drugs, cosmetics and medical devices sold in the U.S. Nearly two-thirds of all consumed in the U.S. are imports, while 80 percent of pharmaceuticals ingredients are imported from abroad.

"The shift in global product flows will make it difficult to identify the `source' of a product and to ensure that all players along the supply chain meet their safety and quality responsibilities," states the report.

The FDA has taken steps to increase foreign inspections in recent years. The agency opened its first inspection offices in China and India in 2008 and 2009. That initiative followed dozens of deaths and hundreds of in the U.S. to the blood thinner - which was primarily made from an ingredient made at a Chinese facility.

The FDA points out that it increased inspections of foreign drug-manufacturing sites by 27 percent between 2007 and 2009. But a 2010 report found that the agency is still inspecting less than 11 percent of the plants on its own list of high-priority sites.

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