by Dr. Alan Inglis
There's a saying when someone is particularly slow or unmotivated that it would take them an hour to cook minute rice.
Well, it would probably take the FDA a month.
Case in point, the FDA announced with much fanfare recently that it was implementing new measures to prevent the contamination of the blood thinner heparin.
Fantastic. That only took a year and a half.
Reports began cropping up in late 2007 of adulterated batches of heparin coming from Chinese manufacturers. Unscrupulous manufacturers often substitute lower-cost materials into big batches of pharmaceuticals, with scary results.
Estimates are that more than 200 people have died from reactions to contaminated heparin.
For heparin, the new standards will mandate that importers and manufacturers test their products for contaminants before they can be sold in the U.S. You know… the kind of thing that most consumers probably assumed was already happening.
The new test is more precise in identifying contaminant chemicals in the heparin batch, according to the U.S. Pharmacopeia Convention, a nonprofit group that developed the standards for the FDA.
Of course, the FDA was in no rush to draft these standards, so why should it be in any rush to implement them? The permanent change won't take place until August, which is almost two years after the first heparin-linked deaths were reported.
I'm glad this test will be implemented – and I hope such testing spreads to other drugs as well. But next time, how about a little urgency? If we need to inconvenience some drug manufacturers so we can save lives, that should be an easy decision.
Unfortunately, in the halls of the FDA, that's no easy decision at all…