Congress, FDA tussle over contaminated heparin supplier
The FDA and Congressional investigators are fighting over its refusal to release information on which Chinese companies supplied a tainted blood thinner that has led to at least 81 deaths in the United States.
Heparin is a widely used blood thinner, frequently given in large doses to patients in order to prevent clotting during complex medical procedures such as kidney dialysis or heart surgery.
Most of the heparin sold in the United States is manufactured from ingredients made in China, a major supplier of drug ingredients to the United States.
The FDA suspects that the deadly heparin originally became contaminated in a Chinese factory, but has refused to tell Congress which companies supplied heparin ingredients to the United States from China. The agency says that confidentiality agreements with the producers bar it from revealing any of their names.
The FDA claims that it does not have the legal authority to prevent the importation of Chinese-manufactured drugs, citing a Memorandum of Agreement that regulates relations between the FDA and China. The memorandum was signed in order to speed the process of allowing FDA inspection of Chinese drug factories in the first place.
Instead, the FDA is relying on companies to voluntarily test their heparin ingredients before distributing them in the United States. Yet such testing failed to reveal the tainted ingredient between January 2007 and February 2008.
Baxter, the country’s major manufacturer of the drug, has developed a new testing method that can distinguish between pure heparin and oversulfated chondroitin sulfate.
One of the plants that the FDA has inspected was Changzhou SPL, a supplier for Baxter. The factory is majority owned by Wisconsin-based Scientific Protein Laboratories Inc. (SPL), the world’s major supplier of heparin’s active ingredient.
At least 12 lawsuits have been filed against Baxter by patients and their family members who claim they were harmed by the tainted drug.