China FDA Highlights Product Recalls, Manufacturers Urged To Make Rapid Responses

Despite being one of the largest medical product markets in the world, China has seen few product recalls. The situation could be changing however as China FDA has requested drug and device manufacturers to quickly withdraw products that have deficiencies and potential safety risks.

BEIJING – In a recent notice to provincial and municipal food and drug authorities, China FDA announced recalls of several medical products. The move signals the regulator’s determination to strengthen enforcement on product recalls, an issue that has until now received relatively little attention.

The products targeted range from medical imaging software to ventilators, and CFDA said that four multinational device manufacturers are voluntary recalling products. According to the agency, the products recalled are imaging sorting and transfer system Centricity PACS from GE Healthcare; embedded nerve electrodes from Medtronic PLC, used in its Reclaim deep brain stimulation therapy for obsessive compulsive disorder; ventilators from Respironics California Inc.; and catheter tubes from Gambro AB.

CFDA pointed to design and manufacturing deficiencies as causes for the recalls in a notice on its Website Aug. 2. In addition, CFDA also highlighted a major recall of tons of whey protein concentrate used in infant formula. Manufactured by dairy giant Fonterra of New Zealand, the products were found to be contaminated with botulism bacteria. Upon notification by CFDA’s counterparts in New Zealand, the Chinese agency called a meeting with manufacturers that imported and used the product.

“If companies don’t recall target products in a timely manner, and if they don’t report product recalls, CFDA will take stern measures to punish the companies. The severe punishment includes halting the manufacturing and marketing altogether in China.”

CFDA identified four manufacturers that imported the contaminated product: Hangzhou Wahaha Group Co.; Shanghai Sugar, Tobacco and Liquor Group, which provided the products to Coco ColaChina in Shanghai; and Dumex Baby Food Co. Ltd, a subsidiary of Danone of France.

After meeting with CFDA, the manufacturers said they would take measures to recall products that have been marketed, and seal off unused materials. Already, Fonterra was among six foreign infant formula manufacturers that saw record fines under China’s Anti-Monopoly Law for allegedly setting minimum prices for local retailers (Also see "A Closer Look: Retail Price Maintenance Is Latest Hurdle For Multinationals In China" - Scrip, 7 Aug, 2013.).

The safety and pricing of baby formula in China is a sensitive issue to both the government and Chinese parents following the melamine safety scare of 2009 (Also see "China Passes Food Safety Law Following Melamine Infant Formula Disasters" - Scrip, 5 Mar, 2009.).

Concerted Campaign, Severe Punishment

In addition to publicly disclosing the recalled products and manufacturers, Chinese regulators are also increasing enforcement to compel manufacturers to take responsibility and voluntarily recall products.

“If companies don’t recall target products in a timely manner, and if they don’t report product recalls, CFDA will take stern measures to punish the companies. The severe punishment includes halting the manufacturing and marketing altogether in China,” warned the agency.

China’s quality control authority, the General Administration of Quality Supervision Inspection and Quarantine (AQSIQ), and CFDA’s local branches are teaming up on the recall campaign. In Shanghai, where Dumex is located, local authorities have sealed off all materials and finished products containing the contaminated whey protein products. Dumex is also required to take immediate actions to alert wholesalers and retailers about impacted production batches, and must publicly disclose details about the recalls.

Meanwhile, the Fonterra recall is widening. On Aug. 5, U.S. firm Abbott Laboratories Inc. was ordered to recall two batches of milk powder packaged by Fonterra. The recalled batches are Abbott Stage 3 formula, which relied on other raw materials but were packaged by Fonterra. CFDA notified Abbott to take responsibility to recall the products and protect the health of Chinese consumers.

“Within 72 hours of the disclosure of Fonterra contamination, we started recalling small quantities of potentially affected products in a precautious measure,” Abbott said in a statement posted inside elevators of residence communities in Beijing. “We are not hiding or covering up any information in this issue,” the notice said, adding, “We’d also like to promise again that all Abbott products marketed in China are safe and reliable.”

Recalls Target Multinational Products?

The growing number of recalls reflects CFDA’s intention to use nationwide recalls to highlight its new, tough stance on product safety, analysts say.

The move could be in response to widely reported recalls of Johnson & Johnson products, which mainly took place in the U.S. but not all recalls included China, said Jin Wang, CEO of Hangzhou-based health care investment firm Manhattan Consulting (Also see "J&J Consumer Business Picks Up, But Analysts See Long Road" - Pink Sheet, 22 Oct, 2012.).

J&J has issued 46 recalls in the U.S. and other markets in the past four years, only 33 in China. CFDA recently called a meeting with J&J executives and asked the U.S. firm to ensure quality and reduce risks. CFDA also called on J&J to take action and disclose recalls to the public in a timely manner (Also see "CFDA Reviews Spate Of J&J Product Recalls, Seeks Quality Commitments" - Scrip, 18 Jun, 2013.).

“Although J&J had explained that the target products are not marketed in China, the frequent recalls and multiple products involved still prompt Chinese regulators to question and look for loopholes and problems in the current Chinese recall system,” Wang told PharmAsia News.

Although domestic manufacturers outnumber multinational firms by a large margin and have been in the center of product quality scandals in the past, they rarely recall products, Wang said. It is more likely for a company to cover up issues of product quality than to take a product off the market, and it will usually not take action unless caught by the government, he added.

To that end, many wrongdoings are unearthed by internal whistleblowers. However, there is no formal system to protect and encourage informants as there is in the United States, Wang said.

Communicating With Manufacturers

The infant formula recall is part of a larger move to root out product quality issues and commercial irregularities in China. After re-organizing itself as a ministerial level agency, CFDA initiated the “Two Strikes, Two Set Ups” campaign to crack down on manufacturing violations and distribution channel wrongdoing (Also see "China FDA Launches Major Enforcement Campaign; Official Cautions Rainy Days Ahead" - Scrip, 22 Jul, 2013.).

Following the announcement, CFDA requested a face-to-face meeting with high-level representatives of 17 local governments. The local governments are required to take concrete action to correct irregularities in their traditional Chinese medicines markets.

CFDA also met with medical device manufacturers and industry associations Aug. 8. The agency planned the whole-day session to update the industry on medical device regulations and implementation policies, and to listen to comments and suggestions from manufacturers and distributors. CFDA also hoped to receive feedback on the Medical Device Regulation Bureau.

Three associations and 38 device manufacturers were invited to the meeting, according to CFDA, including Zimmer Biomet Holdings Inc.’s subsidiary Beijing Montagne Medical Device Co., GE Healthcare, Thermo Fisher Scientific Inc., Bayer HealthCare AG, and major domestic manufactures such as Mindray Medical International Ltd. and Shandong Weigao Group Medical Polymer Co. Ltd.

In late 2012, the agency conducted an overhaul of the device regulatory body, replacing the bureau head Wang Baoting with Wang Lanming (Also see "Asia On The Move – A Closer Look At China SFDA Personnel Changes" - Scrip, 26 Mar, 2013.).

Since then, the bureau has issued several policies to accelerate the device review and approval process, delegating certain review and approval authorities to provincial branches (Also see "China Offers Green Channel To Spur Device Innovation, Import Replacement" - Scrip, 8 Apr, 2013.).

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