Congress has expanded its investigation of contaminated heparin supplies that were imported from China and given to U.S. patients more than three years ago. Hundreds of lawsuits have been filed as a result of patients being injured or killed after being given contaminated doses of the blood thinner. Recently, a jury awarded $625,000 to the estate of a man who died after being given a contaminated dose of the drug.
Members of the House Energy and Commerce Committee have contacted ten drug supply companies requiring documents related to the contaminated drugs. This came after information from the Food and Drug Administration indicated that the companies have information related to the Chinese heparin industry and Chinese heparin supply chains. The letter written by the Committee to the companies stated:
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 pharmaceutical products imported to the U.S. How the Heparin came to be contaminated and the exact nature of the contaminant remain unknown. 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 in the future.
The referenced letter was sent to Amphastar Pharmaceuticals, Momenta Pharmaceuticals, Siegfried USA, Inc., Sagent Pharmaceuticals, APP Pharmaceuticals, Sanofi Aventis, Drug Source Company LLC, Global Pharma Sourcing LLC, Pacific Rainbow International and Sandoz. The investigation into the cause of the tainted heparin supply began in 2008, when lawmakers asked the FDA to probe the incidents. The U.S. Government Accountability Office ultimately placed some blame on the FDA for, among other things, allowing drugs to continue to be imported from Chinese facilities that refused to allow inspections. Committee members have also called on the FDA to release documents related to its response to the unsolved cases. It’s time for Congress to clamp down on imports from China and require Chinese manufacturers to comply with all requests concerning safety issues.
Source: Lawyers USA Online
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