U.S. safety inspectors have never had better access to China’s food and pharmaceutical supply chain than they do now, with Food and Drug Administration officers in three cities.
And with China the fourth-largest source of imported agricultural products for the U.S. in 2009, at $2.87 billion, plus the source of another $1.5 billion in imported medical-related products, inspection has never been more important.
But also, the FDA has never depended more than it does now on China to do the policing.
That’s the message FDA Commissioner Margaret Hamburg put forward Friday in wrapping up her own inspection tour in China. A little over a year into her position at the helm of the FDA, the trained internist and former top New York City health official said her job is to give the FDA the resources it needs, but recognize is limitations.
Even as food and drug safety scandals arise continually in China, the FDA is leaning on China to find problems that might affect Americans.
Gone are the days when every shipment could be inspected upon arrival in the U.S., Hamburg said. “We’re working in a new kind of partnership with sister regulatory agencies with the same challenges of how can you possibly really provide oversight for products coming from all around the world from hundreds of thousands of facilities with complex supply chains,” she said.
“We will never have the resources, human or financial, to inspect all these facilities on a regular basis so we are working through bilateral multilateral arrangements and try to share information and harmonize standards and approaches in ways the benefit all of us as a global community of regulators.”
In late 2008, the FDA opened an inspection office at the U.S. Embassy in Beijing and has since opened in Guangzhou and Shanghai. Key work involves liaising with Chinese counterpart agencies that Hamburg referred to, including the State Food and Drug Administration and General Administration of Quality Supervision, Inspection and Quarantine, or AQSIQ.
U.S. imports of goods the FDA and other U.S. agencies regulate are booming from China, even as scandals continually call into question the nation’s food and medicine safety and oversight.
It’s not all bad news, Hamburg said, noting that news in 2008 that the country’s milk supply was spiked with the industrial chemical melamine represented a “wake-up call” for China, as well as the U.S. She said Beijing now has procedures in place to spot that type of risk.
Yet, she spoke as fresh questions about the safety of milk powder ingested by infants were swirling around China, and specifically a Nasdaq-listed company Synutra International Inc.’s products.
Referring to the separate, earlier melamine scare in milk, she said more troubling is the difficult job of stopping “bad actors who are willing to put human health at risk in order to make more money.”
Hamburg dodged a question about what she would tell members of Congress about tangible results of her visit in terms of FDA’s ongoing quest to get deeper access to the Chinese supply chain, for instance with makers of active ingredients used in pharmaceuticals.
“China is a major producer of active pharmaceutical ingredients and we have had some very focused discussions on that very important component of the supply chain,” Hamburg said. “Our Chinese counterparts have been very interested in working with us to strengthen their systems and to ensure open channels of communication to identify issues of concern so they can be smoothly and effectively addressed.”
Some congressmen have been critical of China’s response two years ago to a scare in the U.S. over contamination of the widely used blood thinner heparin.
Hamburg offered an upbeat message. “This is my first visit to China as FDA heath commissioner and I will leave feeling very encouraged by the partnership that has developed here and very encouraged by the opportunities going forward,” she said.
–James T. Areddy