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States Face Huge Task In Tracking Meningitis-Tainted Drugs
An anonymous reader writes "Confronted with a growing meningitis scare, states are coming under enormous pressure to meet federal requests that they contact more than 1,000 hospitals and clinics that received any injectable drugs from the company at the center of the deadly outbreak."
The solution here is for Congress to close the formulation loophole, and for the Agency and the states to work together to create a unified standard of rules.
I always look to people with "the solution" with a bit of skepticism. In this case, I think you're confusing the possibility of a problem with its likelihood.
If Bruce Schneier is to be believed, risk is always a tradeoff. Let's compare the risk of meningitis with the practice of formulation.
Formulation for offlabel purposes and children's doses meets a need, and I would expect that the population benefits are enormous. This meningitis problem is the first one I've heard about in... ever. And the problem is limited to a small number of people because, as people have pointed out, the issue isn't as much the meningitis, it's not knowing how many people may be at risk.
It would seem to me that the risk of problems with formulation is vanishingly low.
If we "close the formulation loophole" as you suggest, that will put all offlabel and children's doses in the hands of the noble and reputable Big Pharma companies. Won't they choose to skip formulations for which there is no substantial market (children's doses, for instance)? Will they not raise prices mercilessly on a captive market?
I dunno... your solution seems formulaic and reflexive. Shouldn't we think through the ramifications first?