Republicans Continue Heparin Probe

Members of Congress are expanding their investigation of FDA’s handling of the 2008 crisis involving contaminated heparin from China. Several Republicans on the House of Representatives Energy & Commerce Committee sent a letter on May 26 to U.S. Immigration & Customs Enforcement, seeking information about the cause of the contamination. The lawmakers reopened the investigation in February, claiming FDA was unresponsive to their questions about how the blood-thinning drug became contaminated. FDA has concluded that the contamination was economically motivated, but neither the agency nor the Chinese government has identified who is responsible. “There is reason to believe all or some of the individuals responsible for the adulteration are still actively engaged in the Chinese pharmaceutical supply chain and pose a continuing threat to the pharmaceutical products imported to the U.S.,” the lawmakers wrote. Several U.S. patients died in 2008 after receiving the adulterated heparin, which was contaminated with oversulfated chondroitin sulfate.