FDA to open five overseas offices by year's end

Oct 20, 2008 (CIDRAP News) – Aiming to make imports safer, the US Food and Drug Administration (FDA) will open four overseas offices by the end of the year, starting with China and followed by India, Europe, and Latin America, the Department of Health and Human Services (HHS) announced recently.

Establishing the foreign FDA offices is a component of an Import Safety Plan that HHS unveiled in November 2007, prompted by a series of tainted imports including chemically contaminated pet food, toys with lead paint, and seafood containing traces of unauthorized drugs.

HHS Secretary Mike Leavitt said in an Oct 16 press release that the department is making steady progress toward safeguarding the nation's food and medicine supplies, though more work remains. "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," he said.

"Opening these offices will mark a key milestone in the globalization of our efforts to enhance the safety of imported food and medical products," Leavitt said in the statement.

Andrew C. von Eschenbach, FDA Commissioner, said in the statement that the overseas offices—part of the FDA's Beyond our Borders initiative—would allow the agency to improve its oversight by having staff living and working in the countries year-round.

FDA personnel will work with local authorities and industries to provide technical advice, conduct additional inspections, and work with government agencies and private industry groups that are interested in developing certification programs, HHS said. Previously, federal officials depended on border inspections to identify unsafe food and drug products, an approach that it said has not kept pace with the brisk growth of global commerce, the agency said.

HHS said the first office will be located in China, where the department has already received formal approval from the government. The first staff will arrive at the FDA's new office in Beijing this year. The FDA said it will place more staff members at offices in Shanghai and Guangzhou in 2009 and that it expects to place a total of eight US workers in its Chinese offices.

Plans include opening the second overseas office in New Delhi, India, by the end of the year, with at least one additional office in the country in 2009 and a total FDA workforce of 10 employees, HHS said. The department is in negotiations with India to gain formal approval for the offices and staffing plan.

HHS projects that it will open more FDA offices in Europe and Latin America by the end of 2008 and a fifth office in the Middle East in early to mid-2009.

Officials from HHS are also working to complete memoranda of understanding with Belize, Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, and Panama on product safety, according to the press release. Collaborations could include sharing of information on regulatory systems and joint training on food and medical product safety and foodborne illnesses.

In July HHS issued a progress report on import safety initiatives. HHS said in the press release that some of the action items in its plan are still awaiting new authorities from Congress, such as accrediting third-party labs to evaluate compliance with FDA requirements, allowing the agency to require certification of high-risk imports, refusing imports from firms that obstruct FDA access to their facilities, and mandating food recalls when voluntary steps aren't effective.

See also:

Oct 16 HHS press release

Nov 6, 2007, CIDRAP News story "US food safety plan calls for FDA recall power"

July 2008 HHS import safety action plan update

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