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FDA China Office Slated to Open in October

Apr 15, 2008 | Parker Waichman LLP A month from now, the US Food & Drug Administration (FDA) could have full-time personnel on the ground in China, provided the Chinese government gives final approval to the plan.  The assignment of FDA personnel to China comes on the heels of several scandals involving defective drugs and contaminated food ingredients made in that country, most recently tainted heparin that has been linked to dozens of deaths in the US.  The move also marks a significant change in the way the FDA polices drug imports, as previously the agency relied on inspections at points of entry to detect defective drugs.  If all goes as planned, the FDA will open a permanent office in China next October.

In the past year, imports of Chinese drugs and foods have been at the center of several safety scandals.  Most recently, heparin sourced from that country was found to be contaminated with chondroitin sulfate which had been molecularly altered to mimic the drug's blood clotting properties.  Hundreds of people have been sickened in the US because of reactions to tainted heparin, and according to the FDA, as many as 62 people may have died as a result.  Baxter International recalled nearly all its heparin products in the US earlier this year, and other companies, including B. Braun and Covidien, Ltd., have issued recalls of heparin products as a precaution.  There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan.

The news of heparin contamination came almost one year after some pets in the US died as the result of a pet food ingredient shipped from China that contained toxic levels of melamine, which was added to make it appear higher in protein. In Panama around the same time, 120 people died because an unlicensed Chinese chemical plant sold a cheap counterfeit ingredient, diethylene glycol, that was mixed into cold medicine imported to that country. Diethylene glycol contamination also resulted in a recall of Chinese-made toothpaste in the US over the summer.

Shortly after Baxter recalled its heparin, it was discovered that the FDA had never inspected the Chinese plant that supplied Baxter with the raw ingredient used in heparin.  Apparently, a computer error led the agency to believe it had been inspected.  Recent reports have also found that the FDA is ill-equipped to police foreign drug makers. In November, the Government Accountability Office found the FDA doesn’t know how many foreign firms are actually subject to inspection. The agency also could not confirm how many foreign firms have never been inspected. In those rare cases where the FDA actually does visit foreign plants, officials provide advance warning and rely on translators supplied by the companies being inspected, clearly a conflict of interest that compromises the integrity of the inspections.

Last month, the FDA said it would be seeking a more permanent presence in China, and  said it planned to establish eight permanent FDA positions at US diplomatic posts in China. The FDA also said it would hire five Chinese employees in Beijing, Shanghai and Guangzhou. The FDA is still awaiting final approval from the Chinese government on the opening of the its office there, but that the agency expected to begin work in May before the official opening of the office in October.  According to The Wall Street Journal, the FDA's China office will be headed by Christopher Hickey, currently director of the Asia and the Pacific office at the U.S. Department of Health and Human Services.

Government statistics indicate that about 40% of pharmaceuticals and 80% of the chemical ingredients in drugs are imported.  While a large amount comes from China, India and Mexico are emerging as big drug and chemical importers.  The US plans on eventually expanding its presence in those countries as well, and is currently in talks with the Indian government to do so.

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