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Biotech / Medical : Biotech News
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From: Doc Bones10/17/2008 5:41:08 AM
   of 7143
 
FDA to Open Inspection Office in China This Year

Associated Press
OCTOBER 16, 2008, 3:57 P.M. ET

WASHINGTON -- The Food and Drug Administration will establish its first office in China before the end of the year as part of a broader plan to assure the safety of imports from the developing world.

FDA Commissioner Andrew von Eschenbach on Thursday laid out a plan to place more than 60 food and drug regulators world-wide over the next year, with a particular focus on India, Latin America and the Middle East.

The plan for permanent outposts marks a break from the agency's current practice of sending inspectors abroad on individual assignments.

The safety of imported food and drugs has become a growing concern as domestic manufacturers shift operations overseas and foreign producers make inroads here. Over the past year, the FDA has been criticized for failing to prevent a string of safety problems, including contaminated blood thinners manufactured in China and salmonella-tainted peppers imported from Mexico.

"We are sending a very clear message to producers: if you want to have access to our market you need to make products that meet our standards of quality," Health and Human Services Secretary Michael Leavitt told reporters. Mr. Leavitt oversees the FDA and other federal health agencies.

FDA officials said the plan would cost about $30 million in its first year, primarily to set up the offices and hire new staffers, including foreign nationals who would report to the agency.

Mr. Leavitt and Dr. von Eschenbach acknowledged that several dozen additional staffers wouldn't be able to visit the thousands of plants across the globe that fall under FDA's responsibility. They said the U.S. government would need to outsource some inspections to foreign governments and companies, who would verify that plants meet U.S. standards.

Officials said the FDA doesn't have the authority to accredit third-party inspectors and would have to seek Congress's approval to do so.

online.wsj.com
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