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States Face Huge Task In Tracking Meningitis-Tainted Drugs

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  • by Anonymous Coward on Sunday October 21, 2012 @06:13PM (#41724217)

    Wrong. It wasn't regulated by the FDA because the FDA explicitly doesn't have the authority to do so. While the FDA has no authority to regulate the company, that doesn't mean they weren't under strict regulations and weren't being monitored to prevent events like this from happening. In fact, they were: by the state the compounding company was located in. In this case, Massachusetts. Yet again, a failure of Massachusetts to properly regulate businesses in their own state exports death to the rest of the nation, although they'll be hard pressed to beat 9/11 for "most death exported due to state incompetence."

    I'm not sure why people are singling out the FDA or compounding company when the actual organization responsible for ensuring that the medication was safe was the state of Massachusetts itself. They took on that responsibility through regulation, they should OWN that responsibility. But, no, they're blaming the company itself and the FDA rather than their own incompetence in not realizing what the company was doing.

  • by Okian Warrior (537106) on Sunday October 21, 2012 @06:46PM (#41724377) Homepage Journal

    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?

  • by TarPitt (217247) on Monday October 22, 2012 @12:09AM (#41725775)

    Only if your meaning of free is "free of independent trade unions", "free of civil tort damages", and "free of not-completely corrupted regulatory agencies"

    The conservative agenda in the US is freedom only in the sense that you have the freedom to do as you wish with your slaves

Wernher von Braun settled for a V-2 when he coulda had a V-8.

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