Continuing its dig into the 2007-2008 contaminated heparin incident during which more than 100 Americans died, the House Energy and Commerce Committee has written 10 drugmakers that may have knowledge of the Chinese heparin industry and supply chain. The drug companies are Sanofi, Sandoz, APP Pharmaceuticals, Amphastar, Momenta, Siegfried USA, Sagent Pharmaceutical, Drug Source Company, Global Pharma Sourcing and Pacific Rainbow International.
"Documents provided by the FDA indicate that your company has information related to the Chinese heparin industry," letters signed by Committee Chairman Fred Upton and members say. "This information would be helpful to our inquiry." It sets a deadline of July 29 for documents dating back to 2006.
"Dating back to 2008, committee Republicans have been pressing the FDA for answers about the agency's handling of the investigation," a statement adds. "The U.S. Government Accountability Office also faulted some of the FDA's efforts, including the decision to continue allowing drugs to be imported from Chinese facilities that refused to allow inspections."
The House request is for information on heparin-related companies in China and on adulteration of the heparin supply in the U.S. and elsewhere. "How the heparin came to be contaminated and the exact nature of the contaminant remain unknown," the letter says. "It is important to determine how the adulteration happened so that industry and government can take more effective proactive measures to reduce the risk of such adulteration."
- see the announcement
- here's the letter