Recalled Heparin Contaminant Confirmed, And Congress Grills FDA On Inspections

Researchers have identified the chemical in the contaminated blood thinner Heparin that killed 81 people in the U.S. and made patients here and in Europe sick:

The researchers freeze-dried the heparin and used a combination of nuclear magnetic resonance imaging and liquid chromatography-mass spectrometry to analyze its structure. In addition to a known impurity of heparin called dermatan sulfate, they found that contaminated lots contain a molecule that looks similar to heparin and showed it was almost certainly oversulfated chondroitin sulfate.

China says their tests show that only some of the Heparin that caused the problems contained the contaminants, so it therefore must be something else:

They said other contaminants, problems with the device used to inject the drug or health factors with the patients who used the drug could be to blame.

Yesterday, Congress went after FDA Commissioner Andrew von Eschenbach for the FDA’s lax inspection protocols, particularly with regard to foreign factories. According to ABC News,

Estimates suggest more than 80 percent of all active ingredients used by U.S. drug manufacturers come from abroad. But the FDA only inspects foreign drug plants about once every 13 years, compared to every two to three years for domestic plants, according to the Government Accountability Office. The GAO finds that China’s drug plants are inspected once every 30 to 40 years.
 
The FDA plans to establish permanent overseas offices in numerous countries, including China, to help address the problem. More foreign plant inspections than ever were conducted by the FDA in 2007, dedicating about $10 million to the process. But GAO analysis said it would cost the FDA $67 to $71 million each year to inspect the thousands of foreign plants on the agency’s priority list.
 
Still, von Eschenbach told the House Subcommittee on Oversight and Investigations that in heparin’s case, even if the Chinese plant had been inspected years ago, “we would not have detected that contamination” because the test to detect it was just developed.

The GAO also reported to Congress that “as early as 1998, the FDA needed to improve its foreign drug inspection program,” and that “one database showed 3,000 registered makers and another revealed that 6,800 makers actually shipped their drugs into the country last year.”
 
Fun fact: Heparin is made from pig intestines!
 
“US researchers confirm heparin contaminant” [Reuters]
“FDA Chief Faces Wrath of Congress” [ABC News]
 
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