FDA Keeps List of Chinese Heparin Suppliers a Secret
Despite requests from congressional investigators, the U.S. Food and Drug Administration refused to turn over a list of Chinese heparin suppliers, the Wall Street Journal reports.
The request was made as part of a House subcommittee probe into the circumstances surrounding more than 81 deaths in the U.S. linked to contaminated heparin. The FDA refused to identify the Chinese suppliers, claiming that a confidentiality agreement bars them from releasing the information.
Baxter International, one of the largest producers of heparin in the U.S., announced the voluntary recall of nine lots of heparin on Jan. 17, 2008, after reports of allergic-type reactions in patients given the drug. A month later, the FDA released a statement indicating that some patients who received heparin injections suffered symptoms, sometimes fatal, ranging from nausea and diarrhea to shortness of breath, dangerously low blood pressure and allergic or hypersensitivity reaction. The FDA noted that 350 adverse events had been reported since the end of 2007, three times the number that had been reported previously.
Investigators with the FDA and the Centers for Disease Control subsequently announced that the drug had been contaminated with a chemically altered form of chondroitin sulfate at Chinese manufacturing facilities hired by Baxter.
In testimony before the congressional committee, one FDA inspector also admitted that Chinese manufacturers barred him from complete access to the crude heparin supplies.
Representative Bart Stupak (D., Mich.), told WSJ reporter Alicia Mundy:
"The FDA thinks they have everything under control, but they really don't. If I were the FDA director, I'd shut down every drug coming in from China."
According to the FDA, more than a million multiple-dose vials of heparin are sold each month in this country. Baxter sells approximately 35 million units each year, ringing up $30 million in annual sales.
If you have a loved one who has been injured or died after receiving heparin, contact Carey & Danis. We can help. Carey & Danis is a national law firm that represents personal injury victims and their families.
At Carey & Danis, even though our lawyers have recovered more than $695 million through litigation, including individual settlements of over $10 million and class-wide settlements of more than $90 million, it is our clients whom we count as our most important asset.
For more information, fill out our online contact form or call Carey & Danis toll-free at 800-721-2519.
