Three Years After U.S. Deaths and Serious Complications, FDA and Chinese Government Still Have Not Identified Culprit or Contamination Source
WASHINGTON, DC – Relaunching an inquiry spearheaded by Republicans in the previous Congress but largely ignored by federal officials, members of the House Energy and Commerce Committee today called on the Food and Drug Administration to release documents related to its response to the unsolved case of toxic and sometimes lethal contaminated heparin supplies that were imported from China and given to U.S. patients. In a letter sent to the FDA, Committee Chairman Fred Upton (R-MI), Oversight and Investigations Subcommittee Chairman Cliff Stearns (R-FL), and Health Subcommittee Vice Chairman Dr. Michael Burgess (R-TX) argued that the public deserves long-overdue answers about the contamination of this widely used blood-thinning drug in order to prevent similar dangers in the future.
“It has been almost three years since the FDA linked deaths and serious allergic-type reactions of patients in the United States to supplies of heparin that came from the People’s Republic of China which was adulterated with overly sulfated chondroitin sulfate (OSCS). FDA officials believe this was an instance of economically motivated adulteration,” the members wrote. “However, neither the Chinese government nor the FDA has identified those responsible for the contamination or described how the heparin actually came to be contaminated.”
Dating back to 2008, committee Republicans have been pressing the FDA for answers about the agency’s handling of the investigation into the contaminated heparin. 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.
A copy of the letter sent today by Reps. Upton, Stearns, and Burgess to the FDA can be found online here.