WASHINGTON – U.S. Rep. Joe Barton, ranking member of the House Energy and Commerce Committee, today released a Government Accountability Office report that criticizes a number of the Food and Drug Administration’s actions during the 2008 heparin contamination crisis.
“It’s now obvious that FDA has a fundamental weakness in how it deals with the surge of Chinese medical and food imports. The FDA allowed importation of heparin from Chinese processors who refused to permit full inspections of their labs and plants. This was a mistake,” Barton said. “FDA already has the leverage to do in-country inspections in China because Chinese companies want access to U.S. markets, 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.”
Among the GAO’s findings:
• FDA took several actions during the early 2008 crisis involving the contamination of heparin that helped protect public health. However, the GAO also found several areas of concern.
• The FDA inspected several Chinese heparin firms, but some of these firms refused to allow the FDA inspectors full access to records or to conduct a complete inspection of facilities and labs. Despite these refusals by Chinese firms, FDA allowed the firms’ products to be imported into the United States anyway.
• FDA reached out to outside experts to help respond to the crisis, but the FDA did not adequately address the risks of working with certain external entities. In particular, FDA accepted voluntary services from scientists to ties to heparin companies, but did not take steps before accepting these services to assess whether the scientists’ industry ties would compromise the integrity of FDA’s activities or the appearance of integrity, so as to undermine the public perception of FDA’s management of the heparin crisis.
• FDA’s acceptance of voluntary services also exposed the agency to risk of claims for payment for the services provided.
• FDA analyzed adverse event reports involving heparin but was unable to link them to contaminated heparin. This finding validated Barton’s concern back in 2008 when he requested the GAO report that an FDA statement in July 2008 suggesting that FDA had adverse event reports that could link heparin deaths to contaminated heparin lots was not accurate.
A copy of the GAO report can be found here.