Baxter International Inc.’s CEO, Robert Parkinson, said Baxter does not monitor its supply chain deeply enough to know much about the Chinese supplier that made an active ingredient in Baxter Heparin. Parkinson also claims Baxter was unaware the Chinese supplier was never inspected by the Food & Drug Administration (FDA) before it shipped tainted Heparin to the U.S. Baxter contracted with Wisconsin supplier, Scientific Protein Laboratories, and not with that company’s Chinese affiliate. “It’s not unusual for us not to know that the FDA hasn’t inspected a supplier to a supplier,” Parkinson said. Scientific produces the active ingredient for Heparin at a plant in Changzhou and the FDA explained the plant—co-owned by Scientific and a Chinese joint-venture partner—was never inspected because its name was confused in registration materials with a different company that had been inspected.
Heparin is used in surgery, dialysis, and for the bedridden. Other drugs thin blood, but their effects are not as quick, easily reversed, and broadly appropriate. Heparin has been manufactured since 1930 and is administered to millions yearly; Baxter manufactures about half of all multiple-dose heparin vials sold in the U.S. The FDA said it received reports of four deaths and about 350 other health problems associated with Baxter’s heparin since late 2007; 40 percent were deemed serious. Reactions included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that—in some—led to life-threatening shock and, in others, death.
Baxter’s issues are the latest a never-ending stream of life-threatening problems stemming from China—tainted toys, toothpaste, tires, pet food—and increase U.S. concerns with suppliers from less-developed countries. Baxter stopped manufacturing Heparin last week; the FDA began reviewing the plant in China on Wednesday. With over 700 Chinese plants producing active ingredients for drugs, Americans rely on their imports for a significant portion of pharmaceutical products. The FDA said Chinese regulators do not inspect plants that produce strictly for export.
Joseph Acker, president of trade group Synthetic Organic Chemical Manufacturers Association, said quality control falls on Baxter and other firms relying on China for pharmaceuticals. ”We have to be sure that the standards that we set in this country are upheld,” he said. “If that’s not certain, then you just don’t buy material from China until they can demonstrate that they can meet our standards.” Dr. Patrick Soon-Shiong, CEO of competing heparin supplier American Pharmaceutical Products Inc., said his company helped establish 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,” he said.
Trouble with Heparin began surfacing in November when cases in Missouri led to a flood of reports about adverse reactions, some serious. Baxter identified nine lots of suspect product, recalling those lots in January. Parkinson said a top priority is to return Heparin to the market. ”It’s a small product for the industry, but it’s significant in terms of its importance to clinical care. We have, as a company, an obligation to the medical and the patient community to get the product available,” said Parkinson.