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FDA Updates Plan for Office in China

Jun 18, 2008 | Parker Waichman LLP In March we reported that the US Food and Drug Administration (FDA) received approval from the US State Department to establish eight full-time, permanent positions at US diplomatic posts in the People's Republic of China, pending authorization from the Chinese government.  This was one step in the FDA's plans to hire and place staff in China over the next year or so in an effort to approve the safety of imported food and drugs.  The FDA also plans on hiring five local Chinese nationals to work with the new FDA staff at the US Embassy in Beijing and the US Consulates General in Shanghai and Guangzhou.

This week, Health and Human Services Secretary, Michael Leavitt, reported that the US expects to have FDA inspectors in three Chinese cities by the end of this year; however, Li Changjiang, head of the Chinese agency that oversees quality control disagreed, saying that the issue had not been totally resolved because US authorities have not granted permission to permit Chinese food and drug inspectors in the US.  According to Li, “The relevant US authorities are still following through and we have yet to receive the go-ahead” for the Chinese inspectors in the United States.

Leavitt was participating in two days of high-level economic discussions with Chinese officials and said that the Chinese government had approved plans to allow the US FDA in three Chinese cities:  Beijing, Shanghai, and Guangzhou.  Leavitt added that inspectors should be in place “soon,” which he clarified as being by year-end, 2008.  According to Leavitt, plans involve placing nine to 12 US inspectors in offices in each of the three cities.

Earlier this year, a top drug safety official told lawmakers that the FDA needs more to better track products entering the US from the burgeoning group of drug manufacturers, brokers, and distributors currently doing business here.  The FDA focuses on domestic companies, with about 1,200 inspections conducted annually in the US; however, only about 300 foreign facilities are inspected annually and, of these, about 10 percent of the firms shipping pharmaceuticals here, said Dr. Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research.  The permanent overseas offices in China are being created in the hopes of allowing increased access for inspections and greater interactions with manufacturers to help ensure products shipped to the US meet US standards for safety and manufacturing quality.

The issue of food and product safety has made the news often over many recalls of many Chinese products including food products, tainted toothpaste, lead-tainted toys, and defective tires, to name a few.  And, foreign inspections were especially relevant following ongoing and heightened concerns about the blood thinner Heparin which was linked to dozens of deaths and adverse reactions in many hundreds of patients.   

In November, the Government Accountability Office (GAO) found the FDA didn’t know how many foreign firms are actually subject to inspection.  The agency has a list of 3,249 firms, but at the current rate of inspection, it would take the FDA over 13 years to go through each firm on its list.  The agency also could not confirm how many foreign firms have never been inspected.

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