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Let’s Agree
November 9, 2011 Regulation

Let’s agree that we want a federal government agency to have the power to make strong decisions. Let’s agree that this agency is the US Food and Drug Administration. We now have a choice to make.

  1. Allow the FDA to ban everything, but to approve only that which is sanctions (sanction in the affirmative sense).
  2. The FDA bans nothing a priori, but has the power to ban anything which it sanctions (sanction in the prohibitive sense).

In a world where resources are scarce, knowledge is dispersed and tacit, which of the two options would a priori be expected to deliver better outcomes in terms of drug and food safety and costs? Of course in the US we follow 1 and folks who mention 2 as a possibility are told they must want a horrible America. Can you write down a simple model of each and articulate conditions for when you’d choose 1 over 2 or vice versa?

"2" Comments
  1. A priori truths are hard to come by. I’d say it’s axiomatic that whole federal agencies like the FDA are unlikely to be looking for axiomatic truths, and the FDA even less so since it deals with scientific proofs that depend on a conscientious application of the scientific method. Then throw into the mix a preference for ivory-tower university and federally funded research over, say, research done by an evil drug company like Genentech (straw man alert!). And don’t forget those K Street lawyers with the alligator shoes. As Senator Ernest Hollings might say, there’s not a whole lot of axiomatin’ goin’ on there, I say, I say, not a whole lot of axiomatin’.

    No, I think there should be clear standards for clinical trials and a serious search for very harmful side effects whenever the FDA approves a drug, and I’ll go a step further: that drug companies should have legal protection from the shyster “bad drug” lawyers to prevent their bankrupting a company for side effects that were unforseen at the time of FDA approval. The tort lawyers falsely attribute infallability to physicians and expect approval of a drug to be akin to discovering axiomatic truths.

  2. Without the offer of a grade on my transcript, I am reluctant to do the homework. Allow me to skip the construction of models. I do note that now we have Case 1 and its processes. Case 2 would have the FDA act only as a result of an active complaint, like a police agency.

    Historically, the Massengill sulfanilamide poisonings of 1937 (Case 2) and the thalidomide poisonings up to 1961 (Case 1 in the USA; Case 2 in Europe) are articulate examples. We allow the police to be proactive. The “Terry Stop” is the active prevention of a crime not yet in progress. As long as the government is restricted to the protection of rights, we should want them to thwart harms.

    That these services can be carried out by profitable enterprises does not change this question. (I can argue well for so-called “anarcho-capitalism” from the premise that it is not how things should be, but how they are. In short, we all shop for laws, but corporations do so consciously and actively.) We know historically that an open society has information products from general newspapers through offerings such as Consumer Reports, Kiplinger newsletters, etc., and even to the peer-reviewed academic journals and industry trade journals.

    The publication of an experiment in support of a theory in an academic journal would be Case 1: nothing is permitted until it is reviewed. Once that passes, products in service to needs are created. As a result, competing offerings are available and reporting mechanisms compare and contrast. In 1920 liquid crystals were only fats found in carrot juice. Today, we choose among visual display devices.

    (Hmmm…. four paragraphs…. Starting to cross the reward barrier here…)

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