Former Chinese SFDA Chief Executed for Taking Bribes; Agency Cracks Down on Regulation

July 12, 2007
Angie Drakulich
ePT--the Electronic Newsletter of Pharmaceutical Technology

The People?s Republic of China executed one of its former drug safety chiefs, Zheng Xiaoyu, for taking bribes to approve untested pharmaceuticals, including some medicines that contained fake ingredients and led to several deaths.

Beijing (July 11)-The People’s Republic of China executed one of its former drug safety chiefs, Zheng Xiaoyu, for taking bribes to approve untested pharmaceuticals, including some medicines that contained fake ingredients and led to several deaths.

Zheng led China’s State Food and Drug Administration (SFDA) from 1998 to 2005. He was charged and sentenced on May 29 for taking an estimated 6.5 million yuan, or $850,000, in bribes to pass a number of new pharmaceuticals through the system. According to the Beijing Municipal No.1 Intermediate People’s Court, Zheng “sought benefits for eight pharmaceutical companies by approving their drugs and medicine devices during his tenure.” As a result, six medicines approved by SFDA during that period were fake; one approved antibiotic was believed to have caused at least 10 deaths. (1)

According to several reports, Zheng’s execution served as a warning to other potential system-curbers. One of Zheng’s subordinates, Cao Wenzhuang, who was in charge of SFDA’s drug registration approval office, was also issued a death sentence this year for similar crimes. (At press time, the sentence had been delayed). “The government has come under great pressure to overhaul the country’s food and drug safety system following a series of controversies caused by shoddy products and corruption scandals involving high-ranking SFDA officials,” reported the Chinese government’s official website (www.gov.cn).

On the same 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. “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 news briefing (1).

In the last 18 months alone, there have been a number of health crises associated with Chinese-produced products, including the dozens of Panamean deaths caused by medicine contaminated with diethylene glycol, and the pet food scare here in the United States in which a number of Chinese-produced pet foods were found to be contaminated with melamine. According to a July 10 Associated Press article by Alexa Olesen, Chinese-made toothpaste has recently been banned in a number of countries due to traces of diethylene glycol, drug-tainted fish from China has been discovered, and Chinese-based pork has been found to be tainted with clenbuterol, an illegal feed additive.

“We should seriously reflect and learn from these cases. We should fully protect public food and drug safety. The new drug registration regulation, which will come out soon, will ensure the transparency of the drug approval procedure,” said SFDA spokeswoman Yan Jiangying at the news conference. The new five-year plan, she explained, will tighten the supervision of food and drug products to “significantly reduce the number of incidents caused by substandard food or drug products.” (1)
According to an SFDA news release, the agency has revoked the production licenses of five drug manufacturers and three factories in the past year and withdrawn good manufacturing practice (GMP) certificates from 128 drugmakers. SFDA also has “increased the number of GMP inspectors in pharmaceutical factories and monitored the production quality of narcotic drugmakers across the country.” (2)
An ongoing component of the country’s food and drug regulation clean-up includes a review of some 170,000 SFDA-issued medicine production licenses, many of which were approved during Zheng’s tenure.

References:

1. News Briefing on The People’s Republic of China’s official government website, www.gov.cn, accessed July 11, 2007.

2. “China’s reputation at risk, says SFDA,”

People’s Daily

(July 9, 2007), 

http://english.people.com.cn/90001/90776/90882/6210913.html

, accessed July 11, 2007.