Baxter: Fake heparin predated API

It's official: the heparin look-alike that tainted recalled batches of the real drug is a chemically altered form of the chondroitin sulfate you take for knee pain. And though FDA officials wouldn't rule out accidental contamination of the med, signs point to counterfeiting [1]. Cheap to produce, the contaminant could have been mixed into the genuine heparin to boost a middleman's profits. The news has Congress in an uproar, pledging all sorts of future safeguards on foreign drug imports and promising hearings into the heparin debacle next month.

Meanwhile, both Baxter, which unknowingly marketed the tainted heparin before the big recall and production shutdown, and its active ingredient supplier Scientific Protein are pointing farther up the supply chain. The companies said contamination probably occurred at one or more of the three consolidators--companies that agglomerate raw heparin from small workshops for resale--that Scientific Protein buys from.

Counterfeit drugs have been an increasing concern [2] for the FDA. The agency opened 31 counterfeit drug probes in 2007 and 54 in 2006; in 1997, there were just nine. And consider the case of the tainted pet food: A chemical known as melamine was mixed into food ingredients to make it appear higher in protein.

- check out the New York Times coverage [3]
- read the story [4] in the Wall Street Journal
- see the LA Times article [5]
- find out more [6] about hearings at Pharmalot

Related Articles:
Counterfeit drugs plaguing Big Pharma. Report [2]
Scientists say heparin tainted deliberately. Report [1]
Heparin mimic found in suspect samples. Report [7]
FDA moves to allay drug-import fears. Report [8]