Asia On The Move: CFDA Shakes Up Leadership, Again

The top Chinese food and drug regulator has a new head, and the new China FDA commissioner has a long career working at the country’s influential price-setting agency and most recently as an aide to Vice Premier Wang Yang.

Asia On The Move is a regular column highlighting industry personnel changes in Asia-Pacific. Send your submissions to Brian Yang.

China State Council deputy secretary-general Bi Jingquan has been tapped to become the new China FDA commissioner, replacing current commissioner Zhang Yong. Zhang has been in the position since March 2013 when the agency was made independent of the then Ministry of Health and became a ministerial level agency.

According to a Jan. 27 report on government portal Shiheziluzhou Net in Xinjiang, Bi will be both CFDA commissioner and secretary-general of the Communist Party at the CFDA, a minister-level position.

Bi has been the deputy secretary-general at China’s Cabinet, the State Council, since April 2008, when he was tapped to become an aide to then Vice Premier Wang Qishan. Wang is now a standing member of the Politburo and one of seven top policy makers in China. After March 2013 when Li Keqiang assumed the premiership, Bi was tapped to as an aide to Vice Premier Wang Yang, noted the report.

Wang directly oversees food and drug administration and regulation, and in December he represented the Chinese government in the 25th China-U.S. Joint Commission on Commerce and Trade (JCCT). One of the agreements reached bilaterally during the JCCT round was to streamline China’s regulatory processes and cut red tape for imports of new, innovative pharmaceuticals and medical devices (Also see "China Agrees To Erase Import Drugs Approval Backlog Soon" - Scrip, 5 Jan, 2015.).

Although the agreement was reached with China’s Ministry of Commerce rather than the CFDA, Vice Premier Wang Yang’s leadership role carries weight, industry insiders say.

“Wang’s responsibility includes overseeing the China FDA, and it [the agreement] should have the influence over the agency,” Dan Zhang, CEO of contract research organization Fountain Medical Development Ltd. told PharmAsia News in an interview.

Bi appeared at a Jan. 29 China Food Safety Commission’s Second Meeting, along with CFDA deputy commissioner Yin Li. Both China’s executive Vice Premier Zhang Gaoli, who is also the head of the Food Safety Commission, and vice premier and deputy head Wang Yang gave talks to the participants.

Food safety has been a major ongoing concern in China and the CFDA’s first commissioner, Zhang Yong, was previously in charge of food safety at the State Council (Also see "Asia On The Move – A Closer Look At China SFDA Personnel Changes" - Scrip, 26 Mar, 2013.).

Long NDRC Career

At the age of 59, Bi has more than two decades in a career working at price-setting agencies.

After graduating from Peking University in 1982 with an economics degree, he started working for the National Price Bureau, where he took the positions of director at the Rural Products Pricing Bureau and deputy director of Pricing Planning.

After the National Pricing Bureau was merged into the National Development and Reform Commission, Bi became the NDRC’s deputy chief of Pricing Management Bureau, and later the head of the Pricing Bureau.

He became a member of the Communist Party leadership team at the NDRC in 2005 and in 2006, the deputy commissioner of NDRC. In April 2008, Bi moved to the State Council and assumed the position of deputy secretary-general.

Comments on Drug Pricing

In an article for China Pharmaceutical News, a publication under the CFDA, Bi outlined his views on drug pricing, noted local medical news portal Saibailan.

He said that drug pricing reform should consider four aspects: the first is ex-factory prices, which should be clearly labeled outside the package, and the second is to encourage competition, narrowing the price markup for distributors to the 5-7% range.

The third is a zero-markup policy for drugs sold at hospitals and retail pharmacies, with a pharmaceutical affairs fee being added instead. The last is to reimburse drugs that are listed on the national reimbursement drug list (NRDL) according to the prices of their generic alternatives. For patented drugs, patients should shoulder the costs that are over the prices of generics.

In a drastic move announced in late 2014, the NDRC has said it would free up drug pricing, allowing Chinese payer agencies and hospitals to decide prices (Also see "Payers, Hospitals Loom Large In China Drug Pricing Proposal" - Scrip, 4 Dec, 2014.).

Drugs listed on the NRDL will be covered by a reimbursement price to be decided by the payer agency, the Ministry of Human Resources and Social Security (MHRSS) and other related parties. Prices for new drugs still under patent protection and those that are not NRDL-listed will be decided via a negotiation mechanism involving multiple interest groups.

Frequent Leadership Changes

Since the CFDA established itself after the previous State FDA and became an independent agency, several leadership changes have taken place.

In the latest previous announcement, several key positions saw new heads. Wang Zhexiong, for one, became the director of the Medical Device Registration Bureau and former director Wang Lanming became the food and drug inspector general (Also see "Asia On The Move: New CFDA Directors, AZ China GM" - Scrip, 11 Jan, 2015.).

In June, Jiao Hong assumed the position of deputy commissioner. Jiao was most recently CFDA’s general director of Drug and Food Safety, a position she held since April 2013.Jiao’s portfolio now includes CFDA’s legal affairs, medical device registration and regulatory bureaus (Also see "Asia On The Move: CFDA Shakes Up Leadership" - Scrip, 24 Jun, 2014.).

Meanwhile, Sun Xianze, a member of the CFDA Communist Party Leadership Team, became the general director of Drug Safety. Sun’s portfolio includes the Crisis Management and Technology and Standards bureaus.

The CFDA also named Guo Wenqi as the general director of Food Safety, and director of the Human Resources Bureau. Liu Peizhi was no longer the deputy commissioner and CFDA member of Communist Party Leadership Team, Bian Zhenjia, no long held that position.

In April, the CFDA appointed Li Bo as the new head of the National Institute for Food and Drug Control (NIFDC) (Also see "Asia On The Move: CFDA Names New Testing Agency Head, Steve Yang Joins WuXi Apptec" - Scrip, 17 Apr, 2014.).

Then in March, a leadership change took place at the CFDA’s drug review wing, the Center for Drug Evaluation (CDE) (Also see "Asia On The Move: CFDA Names New Drug Review Director, Shionogi Reorgs R&D" - Scrip, 12 Mar, 2014.).

Xu Jiaqi was officially appointed director of the CDE after handling the role on an interim basis for months. Former CDE director Zhang Peipei has been appointed deputy director of the Drug and Cosmetics Registration Bureau and assistant director Feng Yi retired. Feng is now a senior advisor to law firm Covington & Burling.

With the installment of the new CFDA Commissioner there will be even more changes is still too early to tell.