China: Baxter Is Obstructing Heparin Probe

This is the international version of the blame game. Last month, Chinese officials voiced doubt that a contaminant identified in Heparin caused 81 deaths and severe allergic reactions in hundreds of Americans, and suggested the problem could have occurred in the US. Now, they insist the Chinese-made blood thinner wasn’t to blame and accused Baxter International of obstructing an investigation.

“Apart from the US and Germany, more than 10 other countries using heparin products containing the ‘heparin-like substance’ have not reported adverse reactions,” China’s Food and Drug Administration said in a statement, Reuters writes. The agency adds that reactions also occurred in some Heparin batches that didn’t contain the substance, hypersulfated chondroitin sulfate.

But Jin Shaohong, of China’s National Institute for the Control of Pharmaceutical and Biological Products, didn’t address the issue of how the chemical made its way into the Heparin batches during his news conference today. Baxter, you may recall, has recalled batches of the drug heparin that were found to be tainted with the substance.

China’s regulator, meanwhile, says Baxter isn’t cooperating with Chinese authorities. “Baxter failed to provide necessary cooperation in the process of the investigation, which is not conducive to further identifying the reasons for the adverse reactions to heparin,” China’s FDA said. Baxter denied the charge.

Baxter had also destroyed some samples of the drug and production records that China considered key to investigating the cause of the problems, Jin said. “I was very surprised,” he said. “This is extremely regrettable.”

A company spokeswoman said that was not the case. “So far, Baxter has agreed to provide samples to the State Food and Drug Administration in respect to their requests,” Xing Rongwang, associate director of communications for Baxter in China, tells Reuters. “We have been cooperating with all parties involved in the heparin situation.”

China’s FDA argues that the supplier, Changzhou SPL, is partly controlled by Scientific Protein Laboratories, which is based and the US, and should therefore bear responsibility for the plant. The agency adds that Changzhou was not registered because of a loophole in which the company is considered a chemical-maker, rather than a maker of pharmaceutical products.

But US Undersecretary of Commerce Christopher Padilla has said Chinese regulators must strengthen oversight to ensure they have authority over both makers of active pharmaceutical ingredients as well as makers of bulk chemicals which may be used in pharmaceuticals.