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FDA Plan Hopes To Increase Import Safety

Mon, 06/20/2011 - 9:07am
Matthew Perrone, AP Health Writer

WASHINGTON (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 Food and Drug Administration report issued Monday lays out a long-term plan to deal with the flood of imports to the U.S., which have quadrupled over the past decade.

The FDA already shares information on drug inspections with regulators in Europe and Australia. But FDA commissioner Dr. Margaret Hamburg said a more comprehensive, global coalition would be needed to stop unsafe imports from entering the U.S.

"The FDA must further collaborate and leverage in order to close the gap between our import levels and regulatory resources," Hamburg said in a statement. The FDA hopes to have the coalition in place by this time next year, though officials said they have not yet reached out to their counterparts overseas.

While more FDA inspectors will be part of the plan, FDA officials have long acknowledged they cannot "inspect their way to safety." The agency is responsible for imports from more than 300,000 foreign facilities in 150 different countries.

The FDA's plan revives several approaches that have been touted by FDA officials for more than a decade:

— increased data sharing with regulators in foreign countries

— computerized systems for identifying the highest-risk imports

— third-party contractors to help inspect more plants

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 fruits and vegetables 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.

Pew Health Group's director of medical programs, Allan Coukell, said the agency is signaling a new willingness to collaborate with its peers around the world.

"They are saying 'the world has changed and we will have to change how we exercise our oversight responsibilities,'" Coukell said. "They are not pretending the status quo will do and they are not pretending this will go away."

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 allergic reactions in the U.S. linked to a contaminated heparin blood thinner — which contained a key 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 government investigators say the agency is still inspecting less than 11 percent of theplants on its own list of high-priority sites, according to a 2010 Government Accountability Office report.

Agency officials say they are already taking steps to better police food safety, thanks to new powers granted this year.

A food safety law signed by President Obama earlier this year requires the agency to increase inspections of foreign food facilities, directing the most resources to operations with the highest risk profiles. The law requires importers to make sure food is safe and gives the agency stronger authority to deny entry of certain foods into the country.

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AP Writer Mary Clare Jalonick contributed to this story.

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