|FDA Commissioner Margaret Hamburg|
Having already traveled to India to emphasize how important it is for drugmakers to have their act together when making products for the U.S., FDA Commissioner Margaret Hamburg will now do the same in China. She's also expected to break through a logjam that has kept U.S. inspectors from getting visas during a trip there for a meeting of top global pharma regulators.
While in China for the International Summit of Heads of Medicines Regulatory Agencies, Hamburg will meet with top Chinese regulatory officials about working cooperatively on drug and food safety. "I think we are in a productive place to share information and we have rapidly expanded our offices in China," she told China Daily ahead of her trip Wednesday. "We have also trained over 1,000 inspectors in China to ensure drugs and food coming from China meets the highest of standards."
Chinese manufacturers dominate the market for cheap active pharmaceutical ingredients but China has a spotty record ensuring they are safe. The FDA opened an office there to do its own inspections after Chinese-made crude heparin was tied to dozens of deaths of dialysis patients in 2008. The FDA last year got additional funds to expand its operations there, but China has been sitting on visa applications for the extra FDA inspectors, even after Vice President Biden raised the matter during a trip last year. Hamburg, in a conference call Friday to preview her trip, said the matter was close to being worked out. "We're heading into the homestretch," she said, according to Reuters.
The FDA intends to more than double its presence in China, expanding the office of 13 to 34, Reuters reports. There will be 26 U.S. civil servants and 7 Chinese nationals, some to handle drug oversight and some to size up food producers. Nine agency employees are currently awaiting paperwork to get into the country, an FDA spokesperson told the news service.
Hamburg earlier this year made her first visit to India, a country that produces about 40% of the generic and over-the-counter drugs used by U.S. consumers. During that trip, she urged government officials and industry members to make sure they were meeting international expectations for high quality products. Relations between the two countries have been strained some by the FDA warning letters and bans the agency has issued against some of the India's largest drugmakers like Ranbaxy Laboratories and Wockhardt.
But the agency also has had issues with some Chinese manufacturers like Beijing Shunxin Meihua Bio-technical. The FDA last summer banned its products after its employees refused to let inspectors see its entire plant or go over some of the required paperwork. The FDA also discovered it had been buying supplies from a company whose ingredients were suspect. Testing determined some of Beijing Shunxin's products were tainted.
Hamburg told China Daily that she believes China understands the importance of strong oversight, having promoted its FDA to the ministry level last year. "It takes time to build an agency with a knowledgeable staff," she told the newspaper. "Remember the FDA here is over 100 years old."