According to a congressional probe, Chinese officials sandbagged an investigation into the contaminated heparin linked to 81 deaths in late 2007 and early 2008. Texas Republicans Reps. Joe Barton and Michael Burgess say FDA officials have been "severely hampered" by China's foot-dragging in tracing the contamination to its ultimate source.
Baxter announced a massive recall of the blood-thinning drug heparin in January 2008. The FDA eventually determined that the drug had been tainted with a substance that masqueraded as heparin's active ingredient, and traced that contamination to China. But the trail disappeared there into a warren of small workshops that provided raw ingredients to Baxter's API suppliers.
"[T]here are serious limitations on what the FDA can do to pursue civil and criminal investigations in foreign countries," an FDA spokeswoman tells the Wall Street Journal, "especially without the cooperation of the foreign government." And that was precisely the problem, the probe found; as far back as June 2008, Chinese officials said they weren't investigating the heparin trouble.
Not coincidentally, the report from Congress comes as FDA Commissioner Margaret Hamburg is preparing for her first trip to China. Barton says Hamburg should confront Chinese officials about their investigation--or lack thereof--during her trip. Now Chinese authorities tell the WSJ that they've done a thorough investigation. So it could be tough for Hamburg to get any real answers, even in person.
- read the WSJ piece