It took some persuasion from the vice president of the United States, but the FDA will soon add 10 drug inspectors to its office in China to help oversee that country's vast API and drug production industry. If the FDA's experience in India is an indicator, it will mean a raft of enforcement actions in a country that is considered to have weak enforcement by its own agency.
The FDA is adding 19 people to the staff of 9 it already has there, but 9 of those are food inspectors, according to Bloomberg. The FDA opened an office there in 2008 after being hammered for lax oversight when tainted Chinese heparin led to dozens of deaths in the U.S. The FDA has been trying to boost its presence in China for more than a year, but the Chinese government blocked visas of FDA employees assigned there. U.S. Vice President Joe Biden was able to get a final commitment for the expanded FDA presence during a visit to Beijing last week.
"It's a big request for any government to allow an increase in foreign inspectors in your country," Christopher Hickey, director of the FDA's China office, told Bloomberg.
The move should provide some relief to drugmakers as well as U.S. consumers. Western drugmakers are between a rock and a hard place when it comes to Chinese APIs. They know Chinese oversight of bulk APIs is insufficient to snuff out substandard producers, but since China and India have become the key suppliers to the industry, they can't live without them. "If China for some reason decided to stop exporting APIs, within three months all our pharmacies would be empty," Guy Villax, CEO of Hovione, told Reuters last year.
While China is believed to be understaffed and unable to keep on top of its burgeoning drug production industry, Western drugmakers say it is making more of an effort. When drugmakers provide Chinese authorities with evidence of companies making counterfeits of their products, they will take action. Last year China cracked down when it found companies using gelatin from scrap leather that contained toxic chemicals to produce drug capsules. It sent 7 people to prison and closed dozens of production facilities.
India is the other major API maker, as well as the producer of about 40% of the generic drugs sold in the U.S. The U.S. boosted its staff there this year and since then has issued a raft of actions against some of the country's largest generic drugmakers. It has banned drugs coming out of two of Wockhardt's Indian plants this year and banned products from a third Indian plant of Ranbaxy Laboratories, a company that in May pleaded guilty to charges that it earlier had falsified data and then shipped subpar products to the U.S.
It will take about a year to fill out the staff in China, Hickey told Bloomberg. Some earlier hires moved on when they couldn't get visas. The FDA can still send U.S.-based personnel, as it has for years. Hickey hedged when asked if having more inspectors there will lead to more actions. "One thing we have seen with our inspections overseas in India, and here in China, is that over time, inspectors are better able to identify specific problems in the firms."
- read the Bloomberg piece
FDA warning letter lays out issues at banned Wockhardt plants
FDA triples list of banned Chinese heparin ingredient makers
Dangers aside, drugmakers can't live without Chinese APIs
China sends 7 to prison for producing toxic capsules