Three Years After U.S. Deaths and Serious Complications, Chinese Government and FDA Still Have Not Identified Culprit or Contami

Three Years After U.S. Deaths and Serious Complications, Chinese Government and FDA Still Have Not Identified Culprit or Contamination Source
June 29, 2011

WASHINGTON, DC - House Energy and Commerce Committee leaders are further expanding their investigation of the now 3-year unsolved case of toxic and sometimes lethal contaminated heparin supplies that were imported from China and given to U.S. patients. Committee Chairman Fred Upton (R-MI), Chairman Emeritus Joe Barton (R-TX), Health Subcommittee Chairman Joe Pitts (R-PA), Health Subcommittee Vice Chairman Dr. Michael Burgess (R-TX), and Oversight and Investigations Subcommittee Chairman Cliff Stearns (R-FL) are reaching out to 10 companies because documents provided by the FDA indicate that they have information related to the Chinese heparin industry and Chinese heparin supply chains.

The leaders are seeking documents and information from Amphastar Pharmaceuticals, Momenta Pharmaceuticals, Siegfried USA, Inc., Sagent Pharmaceutical, APP Pharmaceuticals, Sanofi Aventis, Drug Source Company LLC, Global Pharma Sourcing LLC, Pacific Rainbow International, and Sandoz.

The committee leaders write, "We believe there is substantial public interest in solving this case.  More than 80 percent of the U.S. unfractionated heparin supply is sourced from China and more than 16 percent of U.S. pharmaceutical ingredients are imported from China.  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 leaders firmly believe discovering the root cause of the heparin crisis is an urgent matter of public health and 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.

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. In February, Committee leaders called on the Food and Drug Administration to release documents related to its response to the unsolved case.

A copy of the letter can be found HERE.