FDA Takes Heat in Heparin Case

May 24th, 2010 | Sources: Wall Street Journal

Subjects:

A congressional investigation into the FDA’s handling of the 2008 outbreak of deaths and anaphylactic reactions caused by contaminated heparin from China has revealed that the agency failed to pursue “specific, credible leads” that could have fingered the culpable organizations.

spoiledrottenThe FDA never did say who was responsible for the outbreak, which caused at least 80 deaths and several hundred severe reactions, according to Joe Barton, the ranking Republican on the House Energy and Commerce Committee.

Nearly all the world’s heparin comes from Chinese farms, where ingredients for the widely-used blood thinner are derived from pig intestines. China-based pharmaceutical companies process the raw ingredients and export them around the world.

In February 2008, US hospitals and dialysis centers began reporting severe allergic reactions and deaths associated with heparin. Six weeks after the outbreak began, the FDA announced it was caused by a contaminant, chondroitin sulfate, that had been added to the raw product to stretch supplies.

In one instance cited by Barton, a foreign “respectable regulatory government agency” tipped-off the FDA that a Chinese company was producing tainted heparin. The FDA never pursued the lead.

A letter penned by Barton also cites an internal FDA memo from April, 2008 indicating the agency was aware that one company, Chongqing Imperial Bio-Chem, was supplying tainted heparin to the US.

Although the FDA subsequently banned US imports from Chongqing, Barton’s letter accuses the FDA of failing to explore more thoroughly the possibility that the company was centrally involved in the scam. In an inspection of the facility later in the year, the letter said, the FDA relied on the company’s president to translate.

A Chinese embassy spokesperson responded that Chinese officials “provided full cooperation to the US in the whole process.”


 

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