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FDA To Open China Office, Others to Follow. But Will it Help?

Oct 20, 2008 | Parker Waichman Alonso LLP

The Food & Drug Administration (FDA)  should be opening its new China office later this year, the Associated Press reports.  The agency hopes a greater presence in China will prevent unsafe imports - such as tainted heparin and melamine-laced foods - from gaining entry to the US. Eventually, the FDA will open similar offices in other countries, but even officials at the agency concede that there still won't be enough inspectors to oversee every foreign facility that produces food and drugs for sale in  the US.

In the past year and a half, imports from China have been at the center of safety worries in the US and other countries.  Earlier this year, heparin contaminated with a counterfeit ingredient was implicated in dozens of deaths in the US, and hundreds of serious reactions both here and abroad.  In the past month, the FDA has issued recalls of several foods imported from China that may have been tainted with the industrial chemical melamine.  Melamine tainted dairy products have hospitalized thousands of children in that country.  

Critic have long argued that the FDA does not have the funding or manpower to police the massive amounts of food and drugs imported from overseas.  A recent report from the Government Accountability Office (GAO) found that, on average, foreign drug plants are inspected only once every 13 years.

The opening of  a Beijing, China office later this year is just the first step in the FDA's plan to expand its presence overseas. According to the Associated Press,  staff posted at the China office will inspect facilities, provide guidance on U.S. quality standards, and eventually train local experts to conduct inspections on behalf of the FDA.  The FDA will eventually open offices in the Chinese cities of  Shanghai and Guangzhou.

China has not been the only country sending questionable imports to the US  This year, peppers from Mexico were implicated in one of the largest salmonella outbreaks in US history, and the FDA recently banned Indian generic drug maker Ranbaxy from importing drugs.  

Over the next year, the agency plans to place 60 food and drug regulators in offices worldwide, focusing on  India, Latin America and the Middle East. According to the Associated Press, 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.

But even FDA Commissioner  Andrew von Eschenbach and Health and Human Services Secretary Mike Leavitt,  whose department oversees the FDA, acknowledge the agency will still have too few inspectors to adequately police every foreign manufacturer that sends products to the U.S.   According to the Associated Press, they are hoping to solve that problem by allowing a voluntary inspection, where manufacturers would pay third-party inspectors to verify that their plants meet FDA standards.  

Beside the obvious conflict-of-interest problems posed by manufacturers paying a for-profit service for their own inspections, many doubt that the FDA will convince overseas companies to participate.  Similar attempts at a voluntary inspections system haven't been well received in the past by overseas manufacturers.  To counter that problem, the FDA says it would offer those manufacturers that do agree to such a program expedited entry for their products at US ports.

But such a program would require the approval of Congress, and many members have expressed skepticism that it would work.  Democrats in the House of Representatives, for example, have a proposed a program that would require companies to pay mandatory user fees to help finance additional FDA inspections.