Congress gave the FDA budget a boost last year to station inspectors in other countries like China, where weak oversight has allowed tainted drug ingredients (and pet treats) into the U.S. But China was not so hot on the idea and blocked visas for the new regulators. Now, with some intervention from the vice president of the United States, the logjam has been broken.
The FDA will soon add 10 drug inspectors to its office in China to help oversee drug and ingredient producers whose products make it into the U.S. supply chain, Bloomberg reports. China has become a key supplier for drugs made or exported here. If the FDA's experience in India is an indicator, it will mean a raft of enforcement actions in a country whose own regulatory system has been unable to keep up with the burgeoning production of active pharmaceutical ingredients. Those 10 are among 19 the FDA is adding to its staff of 9. The other 9 will do food inspections. The FDA has recently been investigating Chinese-made jerky treats that have caused illness in thousands of dogs, killing about 600.
The FDA opened an office there in 2008 after being pilloried by outraged politicians when tainted Chinese heparin resulted in dozens of deaths in the U.S. The FDA has been trying for more than a year to add inspectors there but was stymied by the government. U.S. Vice President Joe Biden was able to get a final commitment 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.
India is the other major supplier of APIs, as well as the producer of about 40% of the generic drugs sold in the U.S. The FDA expanded its operations there this year and 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 from a third Indian plant of Ranbaxy Laboratories. Ranbaxy agreed in May to pay $500 million in penalties and pleaded guilty to charges that it earlier had falsified data and then shipped subpar products to the U.S. The two plants tied to those violations have been banned for years from exporting to the U.S.
China's drug regulatory agency is believed to be unable to keep on top of its rapidly growing drug production industry, but 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 made from scrap leather that contained toxic chemicals to produce drug capsules. It sent 7 people to prison and closed dozens of production facilities.
It will take about a year to fill out the staff in China, Hickey told Bloomberg. The agency stopped hiring for the positions when China blocked the visas, and some earlier hires moved on to other jobs. 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