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.

John Hood [file photo]

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

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On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

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Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

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Abeliovich and Prevail, though, aren’t taking this one lying down.

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CEO Pascal Soriot via Getty Images

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