The U.S. Food and Drug Administration’s announcement Wednesday that low-cost animal cartilage made its way into Baxter International Inc.’s blood thinner provides a clearer picture of what went wrong and raises new questions about Baxter’s oversight of a supply chain that stretches back to hog farms in China.
The disclosure Wednesday about Baxter’s heparin, which is developed from pig intestines, also is raising fears that conventional inspections and quality-control procedures do not adequately protect American consumers at a time when a large share of the U.S. drug supply is imported from places, such as China, where counterfeiting is common and government oversight can be slight, government officials and scientific experts said Wednesday.
The heparin scare comes after nearly a yearlong series of problems involving tainted or dangerous substances found in a series of Chinese products, from dog food to toothpaste, children’s toys to tires. This incident marks a rare instance in which an adulterated substance has been introduced into a product sold to American consumers by a large U.S. drug company.
The foreign matter, which is so chemically similar to heparin that it passed conventional inspections by the FDA and Baxter, was present in far greater proportion than the FDA originally had thought. It amounted to as much as 50 percent of the heparin tested from the nine lots of the raw ingredient used to make the drug, which has been linked to at least four deaths and the serious illnesses of more than 300 people in the U.S.
The FDA disclosed Wednesday the suspect ingredient actually is derived from the cartilage of some other, still-undetermined animal. The ingredient likely was cheaper to produce than heparin, and might have been used to cut costs or to meet production targets in China at a time when a runaway infection had affected more than 250,000 pigs, said researchers and analysts.
The presence of a foreign ingredient raises new questions about Baxter’s oversight because a lack of record-keeping at the China plant makes it more difficult for Baxter and government inspectors to trace the origin of the raw material for Baxter’s product.
“Where are the controls here? What is the process here?” asked Carl Nielsen, who was the FDA’s director of import operations and policy before leaving the agency to form a consulting firm in 2005.
“Ultimately, Baxter is the most responsible” for monitoring the quality of products that move through the company’s pipeline, Nielsen said.
Nielsen points to an inspection report conducted by the FDA late last month, after the deaths and illnesses linked to heparin began focusing attention on Baxter’s supplier, Scientific Protein Laboratories, the majority owner of a plant in Changzhou, China, that produced the suspect heparin.
The wide-ranging heparin investigation now is focused on finding the exact source of the foreign material, and determining when it was introduced into Baxter’s supply chain. But the FDA report notes the Changzhou plant maintained no “impurity profiles” – records that can help investigators trace the origin of a material based on the number and trace amounts of impurities contained in it.