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Angie Drakulich was editorial director of Pharmaceutical Technology.
The US Department of Health and Human Services (HHS) will send the first Food and Drug Administration staff to China, India, Europe, and Latin America before the end of 2008.
Washington, DC (Oct. 23)-The US Department of Health and Human Services (HHS) will send the first US Food and Drug Administration staff to China, India, Europe, and Latin America before the end of 2008, HHS Secretary Mike Leavitt announced last week in a press release.
“We’re making steady progress to better safeguard our supply of food and medicines, though much work remains,” said Leavitt. “In the past year, we’ve upgraded labs and equipment, hired additional staff, and begun implementing product safety agreements with key trading partners, including China.”
The move to expand staff presence abroad, especially in China, comes after a year of negative reports regarding contaminated products and drugs with ties to Asia. Baxter Healthcare’s (Deerfield, IL) heparin was contaminated with chondroitin manufactured at the Changzhou SPL plant in Changzhou, Jiangsu, China. Toothpaste and pet-food products manufactured with ingredients from China were determined to be contaminated with melamine in 2007, and, more recently, milk products from China have been found to have melamine in them as well. In India, FDA issued an Import Alert last month for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants due to good manufacturing practice violations.
“Increasing our presence overseas will provide greater protections to American consumers at home and benefit our host countries as well,” said Leavitt in the press release.
FDA Commissioner Andrew C. von Eschenbach added that the agency’s new Beyond our Borders initiative, established in March 2008, means FDA “won’t have to send our experts to another country to work with foreign governments and regulated industry to improve our oversight-we’ll have staff living there and working on the ground 365 days a year.”
According to the press release, the first overseas office will be in China with the first staff in place in Beijing before the end of the year. Additional staff will be posted in 2009. Staff will also be based in Shanghai and Guangzhou starting next year, for a total of eight US nationals in China.
Plans for a second overseas office will follow in the Republic of India, with the first staff arriving in New Delhi in 2008 and at least one additional office to follow in 2009. A total of 10 US nationals are expected to be based in India.
HHS/FDA offices are also planned for Europe and Latin America before the end of 2008, and a fifth office in the Middle East will be established in early to mid-2009.
“Previously, federal officials relied extensively on inspections at the border to ferret out unsafe goods, an approach that has not kept up with the exponential growth in global commerce,” says the press release.
With the new offices intact, US personnel will work closely with local authorities and industries that ship food and medical products to the US, according to the press release. Their activities will include “providing technical advice, conducting additional inspections, and working with government agencies and private sector entities interested in developing certification programs.”
For more information, visit HHS’s Import Safety Action Plan site at www.importsafety.gov.