Massachusetts Compounding Pharmacy/Meningitis debacle

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  • #19485
    tylerboyd49
    Member

    Here in Tennessee it is still somewhat of a story about the compounding Pharmacy in Massachusetts that shipped 3 lots of spinal injections contaminated with a fungus that caused meningitis in hundreds and killed over 30 people in the past 9 months or so, including many Tennesseans. (Here is the wikipedia article: http://en.wikipedia.org/wiki/New_England_Compounding_Center_meningitis_outbreak )

    As a result, some states have already clamped down on compounding pharmacies with more regulations and I would not be surprised if the Federal government does the same in the coming weeks. Compounding pharmacies currently have different regulations than your typical Walgreens, CVS, Rite Aid, or even independent local pharmacy and the central planners are saying they’re surplus of freedom allowed this tragedy. I believe this particular compounding pharmacy was functioning illegally as a manufacturer more than a “patient-brings-in-prescription-and-receives-medication” type pharmacy (and so their lower prices enticed many hospitals and clinics across the country to purchase from them rather than the typical manufacturers). The fact that they were functioning outside the rules of the FDA and Massachusetts’s Dept. of Health has prompted several to use this as a “capitalism fails” story.

    Now, I know that in a free market, quality control would be valued by customers and could be delivered by private certification, guarantees, etc. But given the current regulatory climate, what should be done with this pharmacy and others like it? Does the Federal government have Constitutional authority over this since the drug was shipped across state lines?

    Also, who should be held criminally liable when people are hurt, whether in FDA-cartel-like industry or in a free market, for innately dangerous drugs (side effects) or in contaminated drugs such as this case? Should it be the manufacturer? The administering doctor, nurse, etc? The dispensing pharmacist? If the patient administers to himself, then no one?

    I know there’s several questions there, so hopefully it will make for good discussion.

    #19486

    This touches on one of my favorite Robert Higgs lectures – the last few minutes, especially, because it is obvious the man cares deeply about others (it is often – falsely – claimed that “libertarians only care about themselves, not the less fortunate. What about the suffering of others” – now, that pernicious lie can be disproven in many ways; but it can be illustrated with Higgs, here). But the whole lecture is good, not just on how quality assurance would be provided in a free market but how it is – or, rather, is not – under the current regulatory regime.

    Also, who should be held criminally liable when people are hurt, whether in FDA-cartel-like industry or in a free market, for innately dangerous drugs (side effects) or in contaminated drugs such as this case? Should it be the manufacturer? The administering doctor, nurse, etc? The dispensing pharmacist? If the patient administers to himself, then no one?

    One option left off of here is the FDA. I’d like to hold them criminally liable for the harm they do. But I suppose that’s not possible under the present regime.

    But, strictly speaking, everyone in that chain could potentially be held liable if they did not do their due diligence. That would be a matter for investigation and discovery in each case. I think “caviate emptor” would go too far; – but yes the patient should also do their due diligence.

    The problem with this individual case and the “capitalism fails” theory is that we don’t have a real market, so it’s (once again) dealing in counterfactuals. But the Higgs lecture is, again, very good on this because it discusses how these individual, obvious cases are pointed to by people who use them to demand tighter regulatory controls, but the deaths caused by tight regulatory control are “unseen.” (Higgs makes the distinction between “Type 1” and “Type 2”) deaths. He points out – several times, IIRC – that even “mainstream” (non-Libertarian, non-Austrian-economist) researchers who specialize in the field have concluded that FDA-style regulations kill far more people every year than they save (and this in studies with all kinds of controls, and often with grant-funding that would incentivize them to reach the opposite conclusion if that was at all even remotely plausible, I might add). However, as with all the “ratchet” effects that Higgs has specialized in, these episodic events are used as anecdotes to form the basis of increasing government.

    #19487
    swalsh81
    Member

    I’m going to answer the Constitutionality question. According to Madison in the 42nd? Federalist, the interstate commerce clause was put in place to give the government the power to stop one state from charging tariffs on goods from other states that re simply passing through their state and things like that. The language is unfortunately overly vague and i would venture to say that that may have been the doing of Alexander Hamilton. It was not put in place to regulate production of individual goods simply because that good happens to flow from state to state. Think trade policy not individual trades.

    Of course the FDA is itself no where found in the enumerated powers.

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