House Energy and Commerce Committee leaders are pressing the Food and Drug Administration for answers as part of 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) have identified very serious public health concerns arising from the ongoing investigation, which they bring to FDA Commissioner Margaret Hamburg's personal attention in a letter sent Wednesday reiterating requests for FDA cooperation with the probe.
In the letter to FDA Commissioner Hamburg, the Committee leaders wrote, "Documents provided by FDA show that over the last few years the FDA has had credible evidence that at least two Chinese firms in the supply chain of Baxter and Scientific Protein Laboratories (SPL), the active pharmaceutical ingredient manufacturer for Baxter, supplied lots of heparin contaminated with oversulfated chondroitin sulfate used to make lots of Baxter heparin. This contaminated heparin has been linked to deaths of American patients. These two Chinese companies are also implicated in supplying contaminated heparin to other heparin companies besides Baxter and Scientific Protein Laboratories (SPL). We also have reason to believe that these two Chinese firms are still supplying crude heparin that is being imported into the United States."
The Committee leaders continued, "Based on available information, we have seen no indication that the FDA has issued warning letters and/or import alerts to these firms even though FDA has issued warning letters and import alerts to other Chinese heparin firms. Moreover, FDA inspections and correspondence with Chinese heparin firms that possessed/controlled contaminated heparin show that in some cases the Chinese firms identified to FDA the particular workshop that provided the tainted heparin and the workshop was then disqualified. However, we have seen no indication that FDA took any further action to alert heparin companies to avoid these disqualified workshops or to investigate the findings."
The Committee leaders are seeking to understand FDA's enforcement policy regarding Chinese firms implicated by industry sources as suppliers of contaminated heparin. 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. The members are concerned that FDA has been less than forthcoming in providing documents and information to committee investigators.
Underscoring the urgency of the investigation, according to the October 2011 issue of The GMP Letter published by FDA News, the contaminated heparin crisis "could still be happening." The GMP Letter reports, ""Because of our inability to identify and trace in some cases who all the different members are of this particular supply chain,' the agency believes the problem is not yet completely under control, Steven Wolfgang, acting associate director for risk science, intelligence and prioritization at (FDA) Center for Drug Evaluation and Research's Office of Compliance, said Sept. 21 at the 20th annual Parenteral Drug Association/FDA joint regulatory conference in Washington, D.C."
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 full inspections. In February, Committee leaders called on the Food and Drug Administration to release documents related to its response to the unsolved case.