The FDA has been trying for several years to expand its inspection staff in China, a country that accounts for many of the active pharmaceutical ingredients used in U.S. drugs. But according to testimony in a hearing last week, the agency currently has only two drug inspectors stationed in the country.
That in a country that Allan Coukell of The Pew Charitable Trusts said "is home to the highest number of sites subject to FDA inspection outside of the United States but in the past has received the lowest levels of oversight compared with other countries." According to Reuters, the testimony was before the U.S.-China Economic and Security Review Commission. The commission is charged with tracking the national security implications of U.S. bilateral trade deals and was checking in on how the country is doing with the safety of Chinese drugs and medical products.
The FDA is in the process of hiring more inspectors to station in China, Christopher Hickey, director of the FDA's China office, told the commission Thursday, but for now, it has only two. That disclosure led Commission Chairman Dennis Shea to observe: "It seems to me you're woefully, inadequately staffed for this job," Bloomberg reported.
"There clearly are challenges," Hickey told the commission members, Bloomberg reported. "We place primary responsibility on industry. We're seeking to get more information from Chinese authorities. We have tools in place to safeguard products into the U.S."
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 said it sends staff from the U.S. over to help with inspections in China. And after receiving a budget boost in 2012 to fund more overseas inspections, the country began hiring inspectors. That effort stalled, however, when China failed to approve their visas, and so some of the new hires took jobs elsewhere. Finally, last fall, Vice President Joe Biden raised the issue with Chinese authorities during a visit to the country and was assured the delays would be resolved.
The plan now is to add 10 drug inspectors to its office in China this year as it triples the size of that operation. Those 10 are among 14 the FDA is adding to its staff of 13. The others will do food inspections. Even without being able to add people in the country, the agency has been able to increase the number of inspections by sending staff from the U.S. and elsewhere. In 2010 the FDA conducted 46 drug inspections in China. Last year it conducted 84, Hickey said.
The FDA has also been adding significantly to its inspection staff in India, another foreign country that produces significant amounts of drugs and ingredients that come to the U.S. The FDA is hiring 7 new employees for the India office, bringing its staff to 19 to handle pharma concerns, as well as device and food oversight. It will now have 10 staff members dedicated to the pharma side. Like in China, a precipitating event started the U.S.moving toward having more inspections there. In that case, it was a whistleblower's allegations that Ranbaxy Laboratories was faking drug tests for getting approvals and shipping substandard products to the U.S. That was more than 5 years ago, and despite regulatory intervention, Ranbaxy has continued to struggle with quality. On Monday, Sun Pharmaceutical said it had a deal worth $3.2 billion to buy Ranbaxy and that it intends to focus on getting it past its regulatory issues.