The heparin story

The public may remember last year's heparin contamination incident for the headlines alleging it was caused by FDA negligence, but a close examination reveals another story, a tale of regulator-industry-academic collaboration and the kind of urgent sleuthing worthy of an episode of CSI. How the problem was discovered and fixed is a more interesting story - with far more relevant lessons for how to deal with future crises - than the simplistic FDA-bashing that has been reported.

FDA critics now concede that its success in rapidly developing and disseminating new screening protocols ended the crisis by making it possible to identify contaminated lots and clear safe heparin for use. This averted the potential calamity that could have occurred if the inability to distinguish good and bad heparin had prompted massive recalls, creating shortages of the widely used life-preserving drug...