China, Vaccines

Former head of China’s FDA booted in wake of searing vaccine scandal as leaders impose ‘severe punishment’

The former head of China’s Drug Administration has been forced to resign in the aftermath of a vaccine scandal that rocked the country.

Bi Jingquan

Bi Jingquan — who presided over China’s drug regulatory agency for three years before a government revamp put him in charge of a market supervision bureau — is stepping down alongside two deputy provincial governors and a mayor in Jilin, where the company at the heart of the scandal is based. Jiao Hong, the current head of the CDA, is being asked to conduct a “deep reflection.”

The news came directly out of a Politburo Standing Committee meeting led by President Xi Jinping, marking exactly a month since the CDA revealed that Changchun Changsheng had falsified records regarding their rabies vaccine, and that their GMP certificate has been revoked.

A few days after that announcement on July 15, Changsheng put out word that they had also been punished for producing substandard DTP vaccines — a mandatory shot for children that prevents diphtheria, tetanus and pertussis (whooping cough).

As public anger erupted, it was further discovered that Changsheng produced and sold close to 500,000 of those problematic doses, almost double the original 250,000 investigators first found.

Concurrent with the Politburo meeting, the State Council has ordered a confiscation of all proceeds that Changsheng has obtained through these illegal activities. And two weeks ago local police filed to arrest 18 staffers involved, including chairwoman Gao Junfang.

The widely reported scandal is a big slap in the face for a drug regulator that’s been branding itself as a beacon of reform, vowing to speed up domestic innovation and facilitate entry of novel foreign drugs while remaining strict on drug safety.

That point is not lost on the Politburo:

[This case] has caused serious adverse impact, both exposing gaps in our monitoring system, and reflecting systemic flaws in the production and distribution of vaccines. We must learn our lesson, be vigilant, clean up the chaos with severe punishment, and accelerate improvement of a longterm mechanism for vaccine and drug regulation.

Severe punishment, of course, is a familiar tactic in Beijing. In 2007, in an effort to demonstrate it’s serious about drug safety, the state executed former drug chief Zheng Xiaoyu on bribery charges.

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Sr. Manager, Regulatory Affairs, CMC
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