FDA Plans for Full-time Staff in China

In the category of finally, or "its about time", the FDA has announced plans to have permanent full time positions to monitor Chinese imports, such as the ingredients for Heparin. This comes in the wake of an increasing scandal related to Baxter's recall of Heparin following reports of deaths and hundreds of adverse reactions.

The FDA's press release follows:

FDA Takes Next Step in Establishing Overseas Presence
Agency on path to establish offices in China

In an important development, the U.S. Food and Drug Administration has received approval from the U.S. State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China, pending authorization from the Chinese government.

This is an important step forward in the FDA's plans to hire and place FDA staff in China over the next 18 months. In addition, the FDA will be hiring a total of five local Chinese nationals to work with the new FDA staff at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou.

"In an age when a border is not a barrier, the globalized economy demands nothing less than heightened regulatory interoperability, information exchange, and cooperation, especially on product quality and enforcement matters," said Murray M. Lumpkin, M.D., deputy commissioner for International and Special Programs, FDA. "Along with the important Memoranda of Agreement signed with two FDA counterpart Chinese agencies, our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs, and medical devices in the global market."

Building the FDA's capacity outside of the United States supports the agency's "Beyond our Borders" initiative. The initiative facilitates the building of stronger cooperative relationships with the FDA's counterpart agencies around the world and enhanced technical cooperation with foreign regulators. The permanent overseas offices in China will also allow greater access for inspections and greater interactions with manufacturers to help assure that products that are shipped to the United States meet U.S. standards for safety and manufacturing quality.

For additional information on the FDA's international programs, please visit:

FDA International Programs.

For more information on the historic Memoranda of Agreement signed in December 2007, between the United States and The People's Republic of China, please visit:

Agreement Between China and US.

Next: Heparin Purity- China Doesn't Seem to Care

For information on the recall, click here:

FDA Information

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Gordon Johnson is the Owner of the Johnson Law Office. He is affiliated with the Nolan Law Group and is co-counsel on all of the firm's Heparin cases.

©Gordon S. Johnson, Jr. 2008

To contact us
call 800-992-9447

For Our Latest Information on Heparin go to our Blog:

Heparin Information

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The New England Journal of Medicine: MIT Study

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Contaminated Heparin Can Do More than Kill

Heparin Lawsuit: Areas of Inquiry

FDA Press Releases

Nolan Files Scott v. Baxter Lawsuit

Reporting Heparin Problems

Understated Adverse Reactions

Baxter Widens Heparin Recall

FDA Intercepting Heparin

FDA Plans For Full-Time Staff in China

Heparin Purity - China Doesn't Seem to Care

Baxter Didn't Know About Absence of Inspection

German Heparin Also Contaminated

Heparin Contaminant Identified

Heparin Recall Timeline

Food and Drug Administration Globalization Act of 2008

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Gordon Johnson is the Owner of the Johnson Law Office. He is affiliated with the Nolan Law Group and is co-counsel on all of the firm's Heparin cases.

©Attorney Gordon Johnson, 2008