That's because the drugmaker doesn't monitor its supply chain to the extent that it would know a supplier in China was never inspected before it began shipment of its Heparin blood thinner, Baxter's ceo tellsThe Chicago Tribune.
Baxter, which stopped making Heparin last week after it was linked to 350 illnesses and four deaths, contracted with a Wisconsin supplier, Scientific Protein Laboratories, and not with that company's Chinese affiliate. And so "it's not unusual for us not to know that the FDA hasn't inspected a supplier to a supplier," Baxter ceo Bob Parkinson tells the paper. The FDA, meanwhile, says its inspectors began looking at the plant in China on Wednesday.
Scientific Protein Laboratories makes the active ingredient for the drug at a plant in Changzhou, China. The FDA explained earlier this week that the plant, which Scientific Protein co-owns with a Chinese joint-venture partner, never was inspected because its name was confused in registration materials with a different company that had been inspected.
Parkinson says that Baxter's auditors had inspected the facility in the last six months, but he declined to speculate on whether they may have missed something. "It is both premature and inappropriate to go down that path," he maintains. [Our thought: Poor choice of words, Bob. That is an appropriate question to ask].
Joseph Acker, president of the Synthetic Organic Chemical Manufacturers Association, a trade group, says the onus for quality control falls on Baxter and other firms that rely on China for pharmaceutical material. "We have to be sure that the standards that we set in this country are upheld," he tells the Trib. "If that's not certain, then you just don't buy material from China until they can demonstrate that they can meet our standards."
Patrick Soon-Shiong, ceo of American Pharmaceutical Products, which is a competing Heparin supplier, tells the paper that his company was involved in establishing procedures and "quality control" to monitor their China suppliers. "The best way to ensure the highest quality of raw material is to have feet on the ground in China who are American-trained and who understand the high level of good manufacturing guidelines with the FDA," Soon-Shiong tells the paper.
Baxter first became aware of trouble with heparin in November, when several isolated cases in Missouri quickly led to a flurry of reports about adverse reactions, some of them serious. Baxter's market surveillance soon identified nine lots of suspect product, and the company in January recalled those nine lots. Parkinson said a top priority for him is returning heparin to the market.
"It's a small product for the industry, but it's significant in terms of its importance to clinical care," Parkinson says. "We have as a company an obligation to the medical and the patient community to get the product available."