FDA will open inspection office in China this year

WASHINGTON (AP) _ The Food and Drug Administration will establish its first office in China before the end of the year as part of a broader plan to assure the safety of imports from the developing world.

FDA Commissioner Andrew von Eschenbach on Thursday laid out a plan to place more than 60 food and drug regulators worldwide over the next year, with a particular focus on India, Latin America and the Middle East.

The staffers will inspect foreign facilities, provide guidance on U.S. quality standards, and eventually train local experts to conduct inspections on behalf of the FDA.

After opening its initial office in Beijing, the FDA expects to post eight U.S. staffers to China next year and open additional outposts in Shanghai and Guangzhou. The government would send 10 employees to India, split between New Delhi and at least one other location yet to be determined.

The plan for permanent outposts marks a break from the agency’s current practice of sending inspectors abroad on individual assignments.

The safety of imported food and drugs has become a growing concern as domestic manufacturers shift operations overseas and foreign producers make inroads here. Over the past year, the FDA has been criticized for failing to prevent a string of safety problems, including contaminated blood thinners manufactured in China and salmonella-tainted peppers imported from Mexico.

“We are sending a very clear message to producers: if you want to have access to our market you need to make products that meet our standards of quality,” Health and Human Services Secretary Michael Leavitt told reporters. Leavitt oversees the FDA and other federal health agencies.

FDA officials said the plan would cost about $30 million in its first year, primarily to set up the offices and hire new staffers, including foreign nationals who would report to the agency.

Leavitt and von Eschenbach acknowledged that several dozen additional staffers would not be able to visit the thousands of plants across the globe under FDA’s responsibility.

Instead, they hoped manufacturers would voluntarily pay for inspections by independent parties — including foreign governments and companies — to verify that their plants meet U.S. standards. Attempts to establish similar programs in the U.S. have had limited success, as many companies balk at paying for their own regulation.

But Leavitt said the U.S. government would reward the practice by giving expedited entry to imports that have been independently inspected, while stepping up scrutiny of those that haven’t.

“We want producers to know that we are going to be looking very carefully at those products that haven’t been independently looked at by someone we trust,” Leavitt said. “That’s a powerful incentive for people to get independently certified.”

Officials said the FDA does not have the authority to accredit third-party inspectors and would have to seek Congress’ approval to do so.

However, Democrats already have proposed a very different plan to increase inspections. Under a bill from House Energy and Commerce Committee Chairman John Dingell, D-Mich., companies would pay mandatory user fees to help finance additional FDA inspections.

Calls placed to the committee were not immediately returned Thursday afternoon.

Dingell and other Democrats have stepped up their oversight of imported drugs in the last year after several high-profile drug safety issues.

The FDA last month barred Indian drugmaker Ranbaxy from importing more than 30 generic drugs — including versions of the popular cholesterol pill Zocor —citing poor quality at two factories in India.

Before that, the FDA linked dozens of deaths and hundreds of allergic reactions in the U.S. to the blood thinner heparin — which was primarily made from an ingredient made at a Chinese facility. The drug was recalled by Baxter International and the U.S. blocked imports from the Chinese company.

The FDA is making progress at inspecting more foreign drug manufacturing sites, according to a Government Accountability Office report issued earlier this year. But the watchdog agency said the agency is still inspecting less than 11 percent of the plants on its own list of high-priority sites.