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Former China FDA chief to resign over the country’s latest vaccine scandal

August 16, 2018
Life sciences

Three of the highest-ranking officials in China’s drug administration—including one who’s since gone on to more powerful positions—face severe punishment for a vaccine safety scandal that has ignited widespread public anger.

Each of those officials from the old China FDA, recently revamped as the State Drug Administration, has been handed different penalties, according to the state-run China Central Television (in Chinese). The crackdown stems from an investigation of Changchun Changsheng Life Sciences, which recently turned up evidence that it had sold nearly half a million doses of ineffective vaccine.

Bi Jingquan, former head of China’s FDA beginning in 2015, was asked to resign from his current position as head of the ruling party and deputy director of the all-powerful State Administration for Market Regulation. The agency, to which the new State Drug Administration belongs, was recently created as part of a government reorg. Bi’s name has already disappeared from the agency’s website.

Wu Zhen, formerly No. 2 at China’s FDA, now faces an investigation by the party’s anticorruption commission. Wu handled drug and cosmetics registration and supervision. His purview includes the Center for Drug Evaluation, which reviews drug applications, and the National Institutes for Food and Drug Control, which is responsible for vaccine lot-release approval.

Jiao Hong, once a deputy director at CFDA and currently chief of the State Drug Administration, will have to hand in a self-review to reflect on her missteps.

The decisions were made at a meeting of the Politburo Standing Committee on Thursday after a discussion about the Changsheng vaccine scandal. The Communist Party group is made up of the seven most senior leaders of China, led by President Xi Jinping.

China’s drug regulator first halted production at Changsheng a month ago, after an inspection found that the company had fabricated production records related to its rabies vaccines. Public anger soon erupted as focus shifted to the drug regulators’ inaction after finding last year that Changsheng had provided 252,600 doses of substandard DPT vaccine meant for children. Further investigation found that the company had actually produced nearly 500,000 doses of ineffective DPT vaccines, state news agency Xinhua reported Wednesday.

Punishing officials marks Beijing’s latest attempt at assuaging public anger, and the moves are likely the most severe actions taken against drug officials in years. The last prominent case dates back to 2007, when Zheng Xiaoyu, who headed the country’s drug regulatory agency for more than a decade, was executed for taking bribes in the millions of Chinese yuan in exchange for favors to drugmakers.

After the Changsheng scandal evolved into public outrage and a general distrust of Chinese vaccines’ safety and efficacy, investigators were dispatched to Changsheng, and initial findings have accused it of using expired ingredients to make its rabies vaccines and having systematically fabricated production records to cover it up.

Since the scandal went public, drug regulators have launched spot checks on all vaccine makers in China. And local police have applied to arrest 18 people, including the company’s chairwoman, Gao Junfang, for producing and selling substandard drugs. The government is working to revaccinate children who were immunized with the problematic Changsheng vaccines.

Besides the three drug officials, punishments were also handed to top government officials in Jilin Province, where Changsheng is based. Thirty-five other officials are being held accountable.

By Angus Liu

Source: Fierce Pharma

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