HHS Preparing to Open FDA Offices in China, India, Europe, and Latin America This Year

The U.S. Department of Health and Human Services will send the first U.S. Food and Drug Administration (FDA) staff to China, India, Europe, and Latin America before the end of 2008, HHS Secretary Mike Leavitt announced today.

“We’re making steady progress to better safeguard our supply of food and medicines, though much work remains,” Secretary Leavitt said. “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.

“Increasing our presence overseas will provide greater protections to American consumers at home and benefit our host countries as well,” Secretary Leavitt added. “Opening these offices will mark a key milestone in the globalization of our efforts to enhance the safety of imported food and medical products.”

“The globalization of the food supply and medical product manufacturing has demanded that we do things differently,” said FDA Commissioner Andrew C. von Eschenbach. “Through our Beyond our Borders initiative, we 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.”

The first overseas office will be in China. The U.S. government recently secured formal approval for the office from the People’s Republic of China. The first staff will be in place in Beijing this year, with additional staff to be posted in 2009. Staff is also scheduled to be posted in Shanghai and Guangzhou next year. The department anticipates a total of eight U.S. nationals in China. Secretary Leavitt is scheduled to travel to China in November to meet with Chinese health officials to review mutual efforts to ensure the safety of food and medical products consumed by the two nations, particularly imported goods.

HHS/FDA plans on establishing its second overseas office in the Republic of India, with staff first posting to New Delhi in 2008 and at least one additional office to follow in 2009. Plans at present are for 10 U.S. nationals to be posted in India. The U.S. government is in the process of pursuing India’s formal approval.

In both nations, personnel would work closely with local authorities as well as industries that ship food and medical products to the United States to improve safety efforts. Their activities will include providing technical advice, conducting additional inspections, and working with government agencies and private sector entities interested in developing certification programs.

HHS/FDA will also be opening overseas offices in Europe and Latin America before the end of 2008, with a fifth office in the Middle East to follow soon in early to mid-2009.

Department officials are also working to conclude Memoranda of Understanding with Belize, Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, Mexico, Nicaragua and Panama to work together on product safety. Their collaborations could include information-sharing on their respective regulatory systems and joint workshops and training on the safety of food and medical products. The parties will also make efforts to find opportunities for joint training for food-borne illnesses and the oversight of food traded internationally.

Increased collaboration and coordination with trading partners and companies exporting goods to the United States is a central component of the Import Safety Action Plan proposed in November 2007 by an interagency working group led by Secretary Leavitt. 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. In addition to border checks, the plan called for partnering with producers of goods overseas to build in quality every step of the way.

Some proposals in the action plan require new authorities to be granted by Congress. The Administration has repeatedly urged congressional action on these, but to date no legislation has passed. Examples include the following:

Authorizing the department to accredit highly qualified third parties to evaluate compliance with HHS/FDA requirements.
Authorizing HHS/FDA to require certification of designated high-risk products as an additional condition of importation.
Authority to refuse admission of imports from a firm that delays, limits, or denies HHS/FDA access to its facilities.
Empowering HHS/FDA to issue a mandatory recall of food products when voluntary recalls are not effective.
Last year, the United States imported more than $2 trillion worth of products, from roughly 825,000 importers, through over 300 Ports–of-Entry. All projections indicate this volume will continue to rise sharply over the coming years as the scale and complexity of international trade multiplies.

More information on efforts to improve import safety, including the new report “Import Safety – Action Plan Update,” is available at www.importsafety.gov.

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