As reported recently by Phil Taylor in Securing Pharma, Leaders of the House Energy and Commerce Committee (I won't name any political parties) have written to FDA Commissioner Hamburg, demanding that FDA release documents from its prior, extensive investigations into U.S. heparin supply chain safety.
Some of those in favor of relaxed reimportation often argue that the drug industry is fear mongering when it points to potential safety problems with drugs or ingredients sourced from abroad. "Be afraid, be very afraid.
Any crime covered by the press inspires a wave of copycats. So, it seems, the global heparin supply chain will have to be closely monitored for some time. Both 2-D NMR and capillary electrophoresis have been recognized as the best ways to assess the purity of heparin.
Janet Woodcock, head of FDA’s CDER, strikes me as the type of person you’d want in charge during a crisis. And that’s exactly where FDA, and CDER, have found themselves this year, so I’m not surprised that Dr. W.
At the American Chemical Society national conference last weekend, Rensselaer Polytechnic researcher Dr. Robert Linhart announced that his team may have built the first fully synthetic heparin. Whether or not you believe that the possibility of another contamination crisis of natural raw heparin exists, the potential for a heparin supply...
This just in from the Chicago Tribune: only a small number of patient deaths connected to tainted heparin could conclusively be traced to material sold by Baxter. How many other ticking pharma QC time bombs are out there, waiting to explode? We'll examine this issue next month from analytical, regulatory...
OK, Rockville's a long way from Miami...but the analytical detective work that FDA, MIT scientists and some companies did into potential root causes of heparin contamination makes a great whodunit. C&EN, an outstanding publication, beat us to it by several months with this gem, published in late November.