The Food and Drug Administration allowed Chinese heparin to be imported into the United States from firms that refused to grant inspectors full access to records and labs, according to a Government Accountability Office report released Tuesday.
The GAO report, requested by House Energy and Commerce ranking member Joe Barton (R-Texas), also faulted FDA's reliance on outside experts with links to heparin companies. FDA boosted its inspections of Chinese heparin plants in 2008 after the deaths of more than 80 people were linked to contaminated heparin, an anticoagulant made of pigs' intestines.
"It’s now obvious that FDA has a fundamental weakness in how it deals with the surge of Chinese medical and food imports," Barton said in a statement. "The FDA allowed importation of heparin from Chinese processors who refused to permit full inspections of their labs and plants. This was a mistake.
"FDA already has the leverage to do in-country inspections in China because Chinese companies want access to U.S. markets," Barton added, "and FDA should use its leverage to insist on full inspections. To protect public health, there must be traceable and accountable supply chains in China — not just FDA keeping its fingers crossed."