Call it the blame game. The U.S. FDA says it's traced contaminated heparin back to 12 companies in China. Chinese officials, however, claim the problem started in the U.S.--and they plan to visit a New Jersey plant this week to investigate. So much for the new spirit of cooperation our drug watchdogs pledged not so many weeks ago.
Now, China doesn't dispute that the blood thinner was adulterated with over-sulfated chondroitin [1], the almost-heparin contaminant FDA uncovered in batches of the drug linked to allergic reactions and as many as 81 deaths. But Chinese officials say that the contaminant did not cause the allergic reactions. They claim that untainted batches also were linked with 100 adverse events.
The FDA, however, says that China's screening tests aren't as sensitive as the ones the U.S. used, and that the heparin China deems contaminant-free actually is tainted. Baxter, which sold the tainted med until problems with it arose, confirmed the FDA's assessment. Plus, the FDA says contaminated heparin made its way to 11 countries. If the problem originated in the U.S., it would be limited to the U.S.
Meanwhile, the FDA also sent a warning letter to Changzhou SPL, the Scientific Protein facility in China that provided active ingredient to Baxter. Changzhou didn't adequately respond to deficiencies FDA inspectors found at the plant--and some pretty scary ones at that. No adequate systems for evaluating heparin suppliers or their crude materials, for instance.
- find the FDA's letter [2] to Changzhou SPL
- see the story [3] in the Wall Street Journal
- read the New York Times article [4]
- check out the item [5] at Pharmalot
- get the Changzhou news [6] at the LA Times
- see a summary [7] of the FDA's probe at MoneyControl
ALSO: A new bill designed to quash counterfeit meds was introduced in Congress last week. The Safeguarding America's Pharmaceuticals Act would create federal standards for packaging and tracking drugs and establish minimum standards for wholesale licensing. Chain drugstores immediately protested, saying the requirements would be too expensive and complicated to implement. Report [8]
Related Articles:
FDA chief suspects heparin 'fraud' [9]
Heparin supply chain full of loopholes [10]
Heparin mimic found in suspect samples [11]
Origin labeling a sticky pharma problem [12]
Post-heparin, no oversight excuses [13]