The New York Times yesterday reported that the FDA has announced that the oversulfated chondroitin sulfate contaminant found in Chinese-made heparin, which has officially been linked to 81 deaths and will soon be linked to a lot more, has also been found in drug supplies in Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and, of course, the United States. Somewhat incredibly, the Chinese maintain that the contaminant is not responsible for the deaths caused by allergic reaction to heparin.
The Times also reported that a GAO report found that the FDA will need an additional $56 million next year to conduct inspections of foreign manufacturing facilities of pharmaceutical drugs. This is incredibly convenient for the FDA because it creates the appearance that the problem was they did not have enough money to inspect the plants. But the failure to inspect the Chinese plant stemmed from the fact that they confused the names of the plants and thought that plant had already been inspected, not a lack of resources to inspect the plant in the first place. Classic pass the buck.
The FDA is also suggesting that had they inspected the plant they still would not have uncovered the contaminant. Maybe that is so, I really don’t know, but don’t you think that had the FDA rolled in, someone in that Chinese heparin manufacturing plant might have said, “Gee, maybe we should take the oversulfated chondroitin sulfate out of the heparin.”
In the end, however, Baxter is the one responsible for a safe heparin product. What was Baxter doing to test heparin to verify its safety? As I have written time and time again, there is nothing inherently wrong with making our pharmaceutical drugs and medical devices in China because it does lead to lower prices at home. But, be it China or Kathmandu, if you are going to go further away from your product you have to put systems in place to make sure the product is being safely manufactured, particularly if it is a life saving product for vulnerable patients, like heparin.
In other news, the Maryland Daily Record reports today that American Capital Strategies Ltd., which has as a 90% interest in one of the companies involved in the chain of distribution, is a Maryland-based company. This is interesting, but I don’t think their ownership interest will pierce the corporate veil and Baxter is the deep pocket with ultimate responsibility for the safety of their heparin product. I am quoted a few times in the article about the heparin class action litigation. (I would provide the link to the article but the Daily Record takes down the article after a day or so. But, if you go to the Maryland Daily Record website today, you will be able to find it.)