The FDA told a Senate panel that heparin from China is most likely tainted for economic reasons. Some of the heparin contained oversulfated chondroitin sulfate, an altered version used as a dietary supplement made from animal cartilage.Oversulfated chondroitin sulfate is chemically similar to the active ingredient in heparin and is cheaper to make. The active ingredient used to make Baxter's heparin was supplied by Scientific Protein Laboratories LLC, of Wisconsin. SPL has centers in China and Wisconsin, but the contaminated heparin has is only linked to China.
Both SPL and Baxter said they believe the contamination occurred at the crude level before it reached the Chinese facility that processes the crude material into the active ingredient. In February, Baxter first it was recalling certain heparin products after receiving several hundred reports of allergic reactions and a handful of deaths.
The FDA has received 62 reports of deaths from allergic-type reactions to Baxter heparin as well as other companies since January 2007. The FDA is trying to open three offices in China by October 2008 in order to improve inspections of Chinese plants that supply many of the active ingredients used in drugs sold here.
The FDA has been under fire from some congressional lawmakers for more than a year over various food and drug-safety problems linked to China. More than 40% of the active ingredients used in drugs sold in the United States are from China or India.
The FDA is not required to re-inspect foreign plants, unlike domestic plants where re-inspections are required every two years. Along with China, the FDA hopes to open offices in India, Europe, the Middle East and South America.
The FDA is funded by a combination of annual appropriations from Congress and user-fees charged to drug and medical device companies.
See: http://money.cnn.com/news/newsfeeds/articles/djf500/200804151702DOWJONESDJONLINE000731_FORTUNE5.htm
