A decade ago, Congress was up in arms about Chinese crude heparin in the U.S. supply chain. Now members are highly concerned there may not be enough of it.
Six congressional leaders from both parties are asking FDA Acting Commissioner Norman Sharpless to give them some assurances the U.S. heparin supply is not in danger of drying up as a result of African swine fever, which is wreaking havoc on pig herds in China, the primary source of crude heparin.
"U.S. dependence on Chinese heparin and on one animal source raises risks of shortages," the representatives wrote in a letter to Sharpless. “Pharmaceutical researchers are raising concerns that the African swine fever outbreak in China 'has the potential to cause an unprecedented shortage of heparin’s raw material.'"
Crude heparin, which is used to manufacture the essential anticoagulant used in kidney dialysis and open heart surgeries, comes from pig intestines and China has reportedly already lost 150 million of its 440 million swine, the letter says.
FDA rules require heparin be manufactured only from pig intestines, because when "ruminant" animals like cattle are used, there is a chance the raw material could be contaminated with bovine spongiform encephalopathy or oversulfated chondroitin sulfate (OSCS), a cheap filler that saves money but that can be deadly to patients. In 2008, Chinese heparin contaminated with OSCS was tied to the deaths of 80 dialysis patients in the U.S. As recently as last November, European regulators banned a Chinese supplier after finding contamination risks
The committee members pointed out that, since the disease was discovered in Chinese herds last year, the country has lost a reported 150 million hogs to the outbreak. While there is no immediate indication that China's hog herd problems are impacting the U.S. heparin levels, the letter points out that the current supply is already stressed. It has faced periodic shortages, like when a Baxter International plant was taken out of production by Hurricane Maria in 2017.
It was a decade ago that the FDA got whiplashed by Congressional leaders over tainted Chinese heparin in the U.S. supply. The investigation began after heparin batches were tied to hundreds of allergic reactions, some that proved fatal. The blood thinner had been tainted somewhere along the supply chain, which stretched into some mom-and-pop workshops in the Chinese countryside.