Heparin Finger Pointing Has Already Started

“A series of independent assessments, inlcuding one by the agency’s own Science Board, have found that the F.D.A. is increasingly overwhelmed by its many responsibilties and is incapable of protecting the public from unsafe drugs, medical devices and food – particularly from China.”

While the Food & Drug Administration continues its investigation into contaminated Heparin blood thinner products, the sparring between Baxter Healthcare and its supplier Scientific Protein Laboratories is underway. A March 6, 2008, New York Times article notes the latest findings of the FDA that Baxter’s heparin products are contaminated and the investigation continues as to how the contamination occurred, whether it is isolated, why the contamination was not discovered by the product’s manufacturer or supplier previously, and whether the nearly 800 reports of adverse reactions and 46 reported patient deaths are attributable to the confirmed contamination.

The article noted that Wayne Pines, a spokesman for Wisconsin-based Scientific Protein Laboratories, wanted to reassure the public that nothing improper had occurred with regard to its procurement and processing of the raw materials utilized in the product, and noted “There is no evidence of counterfeiting or tampering or anything of that nature. No one really knows what happened here.” The raw materials supplier also reiterated, again, that “it is premature to conclude that the heparin active pharmaceutical ingredient sourced from China and provided by S.P.L. to Baxter is responsible for these adverse events.”

Meanwhile, Baxter and its spokesperson have also entered the fray with finger pointing at Scientific Protein and, perhaps, the FDA. Baxter noted that the contamination problem may not be as isolated as indicated previously, since tained lots of blood thinners came from Scientific Protein Laboratories’ processing plants located in China and Wisconsin. According to media reports, Baxter began its investigation into possible contamination in the Fall of 2007 and claims that Baxter’s findings “touched on the areas” as those noted in the FDA inspection. Scientific Protein Laboratories, however, questioned the nature of the probems that Baxter contends were noted in the Fall of 2007 and why those problems were not addressed prior to the recent FDA inspections.

The FDA is also under scrutiny with this latest in a long series of serious threats to public safety. The FDA has admitted culpability in failing to properly inspect a Chinese plant implicated in the heparin contamination controversy. There are also concerns about the ability of the FDA to protect consumers from adulterated products. A recent Government Accountability Office report entitled “Preliminary Findings Suggest Weaknesses in FDA’s Program for Inspecting Foreign Drug Manufacturers” noted that over a six-year period the FDA was only able to inspect less than 10% of the approximately 700 medical device plants currently operating in China and providing drugs, devices and raw materials to manufacturers in the United States. For years, the FDA has been lamenting that a significant lack of funds and lack of enforcement authority has hampered its ability to properly ensure the safety of the nation’s pharmaceutical and medical device products. This is particularly disconcerting as our court system and current administration have been aggressive in their efforts over the past few years to claim that state court actions are pre-empted and to essentially immunize drug and device manufacturers from liability for defective products based upon the obviously false assumption that the FDA has the ability to adequately protect consumers. Hopefully, this latest drug safety failure will refocus attention on this issue, just as the memories of Vioxx are fading, and stem the tide of legal efforts to permit defective drugs to remain on the market and the manufacturers to escape liability or require them to assume proper responsibility to ensure the safety of their products.