I wrote last week about how the FDA’s mixup with Chinese factory names kept it from inspecting the Chinese facility producing the main ingredient for Baxter’s heparin; this problem came to light after the drug was implicated in four deaths. (To date, more than 400 adverse reactions have been reported.) Today, articles in the New York Times and Wall Street Journal explain what drug companies and the FDA are dealing with when they rely on Chinese production.
The NYT’s David Barboza and Walt Bogdanich get different answers about the supply chain of the factory that generated much of Baxter’s heparin, depending who they ask:
The owner of the factory, which is known as Changzhou SPL, says its supply chain is safe. It buys raw material from only two reputable wholesalers, it says, and audits their 10 to 12 suppliers.
“We have a collection chain in place, and we stick with that,” said David Strunce, the president of Scientific Protein Laboratories, an American company that owns a majority of Changzhou SPL. He declined repeated requests from The New York Times to identify those smaller suppliers, saying it was proprietary information.
But interviews with dozens of heparin producers and traders in several Chinese provinces, as well as a visit to a village near here dominated by tiny family workshops that process crude heparin from pig intestines, show the difficulties confronting investigators as they seek to trace the supply chain. The picture that emerges is of a chain more complex, and less orderly, than the one Mr. Strunce laid out.
The Chinese heparin market has become increasingly unsettled over the last year, as pig disease has swept through the country, depleting stocks, leading some farmers to sell sick pigs into the market and forcing heparin producers to scramble for new sources of raw material. Traders and industry experts say even big companies have been turning more often to the small village workshops, which are unregulated and often unsanitary.
Here are their descriptions of how heparin is made and of a village that’s effectively become a heparin production center:
The process of making heparin begins with the intestines of slaughtered pigs, from which mucous membrane is collected and cooked, eventually producing a dry substance known as crude heparin. …
In a village called Xinwangzhuang, nearly every house along a narrow street doubles as a tiny heparin operation, where teams of four to eight women wearing aprons and white boots wash, splice, separate and process pig intestines into sausage casings and crude heparin.
The floors had large puddles and drainage channels; the workshops were dilapidated and unheated; and steam from the production process fogged up the windows and soaked the walls. There were large ovens to cook ingredients and halls lined with barrels to store enzymes, resins, intestines and wastewater.
“This is our family-style workshop,” said Zhu Jinlan, the owner of one heparin operation, who stopped sorting pig intestines and invited visitors to a back room, where she lives with her husband and child. “We’ve been doing this about 10 years.”
Experts say the small, unregulated factories could pose dangers because they do not have the same controls and rules as large slaughterhouses, which also produce crude heparin.
“If you don’t control the incoming source, it’s very hard to get rid of the contaminants,” says Liu Jian, a heparin expert at the University of North Carolina.
What’s China’s response to all of this? Basically, that if drug companies and FDA don’t like what’s going on, they’re going to have to do something about it themselves. WSJ’s Gordon Fairclough writes:
China’s drug-safety agency, responding to questions about oversight of an exported blood-thinning compound, said checks of pharmaceutical ingredients made in China are ultimately the responsibility of countries that buy them.
The State Food and Drug Administration said it works with foreign counterparts to monitor drug-ingredient production. But it said that based on international practice, “safeguarding the legality, quality and safety of active pharmaceutical ingredients” is up to importing countries. …
Yan Jiangying, spokeswoman for the State Food and Drug Administration, said that in China, producers of active pharmaceutical ingredients must be drug companies that are “registered and certified” by her agency. She said foreign buyers should check this certification and importing countries “should make strict tests” on ingredients and drugs.
Meanwhile, here in the U.S., FDA chief Andrew von Eschenbach admitted to Congress that his agency needs more money – more than what’s in Bush’s proposed budget – and a “systemic overhaul that must go on over a period of years.”