In The Field

Sep 02, 2007
By Pharmaceutical Technology Editors
Volume 31, Issue 9


US and China Crack Down on Regulation after SFDA Chief Executed

The People's Republic of China executed one of its former drug safety chiefs, Zheng Xiaoyu, on July 11, 2007, for taking bribes to approve untested pharmaceuticals, including some medicines that contained fake ingredients and led to several deaths. Zheng, who led China's State Food and Drug Administration (SFDA) from 1998 to 2005, was charged and sentenced for taking an estimated 6.5 million yuan, or $850,000, in bribes to pass a number of new pharmaceuticals through the system.

The execution followed a series of negative events tied to China's exports over the past 18 months, including contaminated "made-in-China" products such as pet food, toothpaste, juice, and fish found in the United States, Panama, and other countries. The US Food and Drug Administration has since stepped up inspections and banned imports of several Chinese farm-raised foods to eliminate any potential health risks.

On the day of Zheng's execution, the Chinese government released a more strict set of drug registration regulations for officials in an effort to close a number of loopholes in the system. According to an SFDA news release, the agency also revoked the production licenses of five drug manufacturers and three factories in the past year and withdrew good manufacturing practice certificates from 128 drugmakers. An ongoing component of the country's food and drug regulation cleanup includes a review of some 170,000 SFDA-issued medicine production licenses, many of which were approved during Zheng's tenure.

"Some applicants' research documentation has been substandard, there have been serious problems with fraud and fakery, and it's been nigh impossible to ensure pharmaceutical safety," said Wu Zhen, deputy head of SFDA, at a July 11 news briefing.

A US delegation of health officials visited China in early August on a fact-finding mission regarding food and drug safety issues. The mission was meant to spark discussions in an effort to create bilateral agreements on food and feed safety, as well as on drug and medical device safety by the year's end, according to a July 30 statement from the US Department of Health and Human Services (HHS).

Specifically, said HHS Secretary Mike Leavitt, the US is looking to attain three things: "better cooperation," "better information," and "to have the Chinese devise and enforce regulations that we can understand, with which we agree, and in which we feel confident."

The result of these and future meetings between US and Chinese representatives will be included in the recommendations of the US Working Group on Import Safety, chaired by Leavitt, to be presented to President George W. Bush this September.
-Angie Drakulich


Xcellerex Receives US Grant for Biopharmaceutical Production

Xcellerex, Inc., based in Marlboro, Massachusetts, received two Phase-I contracts from the Defense Advanced Research Projects Agency for the Accelerated Manufacture of Pharmaceuticals (AMP) program on July 17.

The AMP program is a three-phase program in which the US military is focused on technologies for producing emergency therapeutics and vaccines. Total funding for the two Phase-I contracts is more than $13 million.

Company Notes
Phase I of the AMP program is focused on optimizing host strains that will express a model vaccine and antibody and demonstrate small-scale production. Subsequent phases will be aimed at rapid process optimization, scale-up, and cost-effective production.

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