As China pumps up drug exports, FDA worries about inspections

Print 09 October 2015
EJ Lane / FeircePharmaAsia

Expectations that the U.S. FDA is ready to take a harder look at products from China, mirroring efforts seen in India in the past few years, has brought the shortage of inspection manpower for drug manufacturing in China into sharper focus.

Bloomberg noted that China and India manufacture more than 80% of the main active ingredients in the world's drugs, including in the U.S. and Europe, citing an Institute of Medicine report. India is focused on finished generic products and China on active pharmaceutical ingredients (APIs).

But Chinese manufacturers increasingly want to enter the finished drug market, and that means regulatory oversight, Bloomberg said, while noting that there are only two FDA drug inspectors in the country to oversee about 700 facilities involved in drugmaking.

Plans to boost the number to 26 inspectors for drugs and food have been stymied by a long-running fight over visas, and that tension has escalated as seen in a recent action against Pfizer's ($PFE) joint venture partner in China, Taizhou-based Zhejiang Hisun Pharmaceutical, Bloomberg said.

Zhejiang Hisun Pharma received a FDA warning letter in September over insufficient data for 29 of its APIs, with 15 halted for import into the United States. The action may cost the company sales of RMB72.4 million ($11.36 million) in the fourth quarter of 2015. Hisun, in a statement, said it has addressed the problems.

But the warning highlighted FDA concerns to avoid situations like the one that arose in 2008, when a blood thinner called heparin was made with contaminated Chinese ingredients and linked to 246 deaths in the U.S.

"We're hearing the Chinese are definitely interested in developing innovative products that aren't just for the Chinese marketplace, but that are for the global marketplace, for the U.S. marketplace," Leigh Verbois, the newly appointed director of the FDA's China office in Beijing, said in an interview with Bloomberg.

Chinese drugmakers say they are trying to fix their problems, and the FDA's Chinese counterpart, the CFDA, seems committed as well, Verbois toldBloomberg. The FDA conducted 120 inspections of drug facilities in China last year, a spokesman for the agency told Bloomberg.

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