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FDA Want US Inspectors Stationed In Foreign Countries

Jan 25, 2008 | Parker Waichman LLP
Inspectors In Foreign Countries

FDA Like To Go Global

The Food & Drug Administration (FDA) would like to go global. In an effort to improve the safety of imported foods and medicines, the FDA wants to post its own inspectors in embassies and consulates throughout the developing world.  According to The New York Times, the “boots on the ground” initiative would focus on nations like India and China and regions like Central and South America and the Middle East.

The FDA has jurisdiction over 80% of the US food supply and all prescription and over the counter medications.   But while imports of both food and drugs have increased dramatically, the FDA inspects only about 1 percent off the imported goods under its oversight.  The FDA’s oversight of imports has been under scrutiny since last year, when dozens of imported products were recalled over safety issues. Foods from China, particularly seafood laced with illegal levels of antibiotics and toxic pet food ingredients, have been of special concern. The outcry over those scandals has led the FDA to reexamine its food safety procedures, especially regarding imported products.

Traditionally, the FDA had been a reactive organization, and steps up inspections of particular products when problems arise. But since the safety scandals of last year, the agency has been trying to engage more “risk-based” approach that would focus on high-risk products and countries whose imports have a troublesome track record.

FDA Sends Inspectors To Dozens Of Countries

According to The New York Times, the FDA already sends inspectors to dozens of countries each year to inspect pharmaceutical plants and clinical trial sites.  And in December, the United States and China agreed to a greater American role in certifying and inspecting Chinese food products, including an increased presence of American officials at Chinese production plants.

But FDA commissioner Dr. Andrew von Eschenbach said in a briefing with reporters that he wanted the agency’s presence abroad to be on an “ongoing and continuous basis rather than episodic and periodic.”   This would be a marked expansion of the role the FDA now plays in countries that import to the US, although the agency has long helped to train foreign food and drug inspectors and even advise in the writing of legislation to empower foreign versions of the FDA.

But the ramped up foreign inspection plan is still far from being a reality.  Von Eschenbach said he wasn’t sure where the money for the plan would come from – the FDA could ask for additional financing from Congress for the inspectors or find the money in its existing budge.  Although some in Congress have advocated a bigger budget for the FDA, the Bush Administration has been less than supportive.

Von Eschenbach also said he would have to work out other details with the State Department, including how such inspectors would interact with other parts of the federal government. In addition, FDA inspectors would not be sent to a country unless their presence was requested.

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