FDA chief suspects heparin 'fraud'

The FDA believes Baxter International's recalled heparin was tainted "by virtue of economic fraud," Commissioner Andrew von Eschenbach told a Senate panel yesterday. That heparin has been linked with hundreds of allergic reactions and 62 deaths [1] in the U.S.; some of it contained oversulfated chondroitin sulfate, a contaminant that is chemically similar to heparin's active ingredient but cheaper to make.

After the committee hearing, von Eschenbach backpedaled a bit, saying that the agency doesn't have proof that the drug was deliberately contaminated somewhere along its long supply chain, which includes small workshops and API manufacturers in China. Both Baxter and its API supplier, Scientific Protein Laboratories, say they believe it was tainted before it reached SPL's Chinese processing plant [2]. "One thing you always wonder about is whether it was done in order to be deceptive," von Eschenbach told reporters after the hearing.

Meanwhile, industry experts wonder why a spike in the price of crude heparin didn't raise red flags for drugmakers. SPL says that its costs doubled in the last half of 2007, and it passed some of that increase along to customers. An SPL spokesman said the company attributed that price hike to supply problems and didn't have any safety concerns; the FDA said it didn't see the price increase as a signal of quality problems. But some in the industry say that a sudden spike in prices should have piqued SPL's interest. "I don't know whether anyone could have detected the contaminant early on, but at least they should have been looking," one drug executive said. Hindsight, of course, is apt to pick out red flags like a hawk spies field mice.

- see the article [3] at CNN Money
- check out the Chicago Tribune coverage [4]

ALSO: Real-time drug safety monitoring--like the system proposed yesterday by the FDA--won't lead to a slew of lawsuits and regulatory withdrawals because the data will tell the story, Drug Wonks concludes. Report [5]

Related Articles:
Heparin supply chain full of loopholes. Heparin report [6]
Heparin mimic found in suspect samples. FDA report [7]
Origin labeling a sticky pharma problem. Labeling report [8]
Post-heparin, no oversight excuses. Heparin report [9]