Heparin probe studies supply chain

WASHINGTON — The investigation into a blood thinner suspected in 19 U.S. deaths is focusing on the possibility that raw biological ingredients were contaminated even before they reached a factory in China, manufacturer Baxter International said Friday.

That raises the prospect that the problem could have occurred somewhere along a supply chain that includes layers of middlemen and originates in pig farms. The generic medication, heparin, is derived from a substance found in the lining of pig intestines. It is used widely to prevent dangerous blood clots from forming during kidney dialysis and cardiac surgery.

The case has reinforced concerns about quality-control problems with Chinese products. But unlike last year's pet-food recall, it was frail patients who suffered the ill effects of the drug contamination. Some suffered life-threatening allergic reactions.

The Food and Drug Administration (FDA) announced new testing requirements for all imported heparin Friday. Manufacturers who do not agree in advance to sophisticated safety tests will have their shipments held at ports of entry until the government can test them.

FDA officials said they are close to identifying the mysterious look-alike ingredient that contaminated the Baxter heparin and prompted a recall in February. The substance, which acts much like heparin, could not be detected with conventional tests for drug purity and potency.

Once the contaminant is identified, investigators should be able to tell more about whether it was added deliberately or occurred naturally or as a result of a problem with processing, FDA Deputy Commissioner Janet Woodcock said.

"We are very close," she said. "When we complete that, [it] will help our understanding of how it got in."

The source of the contamination might remain murky, however, if it occurred along the chain of farmers and middlemen who handle the material in China, where the FDA's regulatory reach does not currently extend and where local manufacturing standards have been called into question.

The FDA announced Friday that it hopes to place regulators in China, pending approval from the Chinese government.

The State Department approved a plan to establish eight full-time, permanent FDA positions at U.S. diplomatic posts in China. The agency also plans to hire five Chinese employees to work with it at the U.S. Embassy in Beijing and the U.S. consulates in Shanghai and Guangzhou.

"Our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs and medical devices in the global market," said Murray Lumpkin, the FDA's deputy commissioner for international and special programs.