Heparin Crisis Leaves Pharma Bleeding
As a law in my state, drivers are not “allowed” to pump their own gas. I suppose it has helped the Oregon economy with providing additional (read: low wage) jobs. In turn, our gas taxes may be a little higher than the rest of the country’s. Last week, however, as I pulled up to take another hit to the family budget with another fill-up, I noticed a sign at the station declaring “diesel customers: you are responsible for making sure the right gas is pumped into your vehicle.”
What? Excuse me, but isn’t that the attendant’s job?
I got the same feeling last month when I read a WSJ article about how the five major heparin manufacturers have agreed to test all shipments of heparin ingredients or finished products “to see if there is any contamination.” In part, this was a response to China’s State Food and Drug Administration’s declaration that it is the responsibility of the receiving countries to check the pharmaceutical ingredients imported from China.
Did I miss something? What does “if there is any contamination” mean? First, there isn’t supposed to be any contamination (now identified as over-sulfated chondroitin sulfate) in any raw material or drug product … period. Also, isn’t this why GMPs, state regulatory inspections, and the entire regulatory system exist? Even if raw-material suppliers are registered as chemical companies and not necessarily pharma ingredient suppliers, due diligence over the supply chain and production process should inherently mandate appropriate control—should.
Last week, China finally announced it would require its raw-heparin producers to make “improvements” to their management and testing procedures. But, 19 deaths and widespread recalls later, is it too late to repair the once-again weakened links of trust among patients, drug makers, and pharma scientists worldwide?
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