The Worst Piece of Shit Ever Written

There is so much wrong with this, even before the idea of the FDA as an independent agency.  Reasoning from NYT columnists, and even Harvard professors, is clearly not a premium in their hiring agencies.

But seriously, I read shit like this from a professor of a program i would have been interested in at 18 and am grateful I didn’t have the grades and desire to waste on prestige. This is shit.

I can elaborate on why I think so if anyone needs me to, and if anyone actually reads this and asks me to explain myself in the comments, I will.  Otherwise, I am not wasting my time looking at this piece of garbage any longer.

Okay, okay, I will drop a hint, this professor thinks more government agencies should be unaccountable to anyone, like the Federal Reserve.  The professor thinks that would be a good idea.  I repeat, the FDA should be accountable to NO ONE.  I haven’t even mentioned that the professor thinks the FED is a good model, nor his severe lack of understanding in how our economic system works.  Okay, I’ll stop.  You, the reader (if you are there) already know all of this.  If you haven’t read it, I am sorry I put it in front of you.  I hope your eyeballs forgive me in the future.

Cheers!

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One thought on “The Worst Piece of Shit Ever Written

  1. December 13, 2011
    Free the F.D.A.
    By DANIEL CARPENTER

    Cambridge, Mass.

    THE unilateral decision last week by Kathleen Sebelius, the secretary of health and human services, to block the Plan B One-Step contraceptive pill from being sold to adolescents without a prescription is shocking in more ways than one.

    Not only was it unexpected, but for the first time in American history, a cabinet secretary — and by extension, a president — has overruled a drug-approval decision by the Food and Drug Administration.

    The precedent risks placing the real power for drug approval not just with a cabinet secretary, but with the White House itself. The only solution, then, is to make the F.D.A. truly independent. Americans have already done this, through the Federal Reserve, to protect our money supply from political meddling; it’s time to do it for drugs.

    True, Ms. Sebelius’s decision was entirely legal: the federal Food, Drug and Cosmetic Act of 1938 gives authority to “the secretary” in the department in which the F.D.A. resides. And F.D.A. rulemaking — the creation of new regulations that govern not a specific case but a range of activities, like rules for testing or the way drug companies synthesize their compounds — has long been overseen by high officials, not least by the president’s Office of Management and Budget and, before that, by the secretary of health and human services and her predecessors in previous departments with different names.

    But the decision nevertheless sets a radical precedent. The key part of the Food, Drug and Cosmetic Act holds that no drug can be sold in interstate commerce without prior approval by the F.D.A. And until last Wednesday, the decision of the F.D.A. commissioner was final. That power still rests with the federal government, but as a result of last Wednesday’s decision, it now arguably rests in the White House.

    That’s not just a symbolic change; it could have drastic effects on regulatory policy. The F.D.A. entrusts drug-review decisions to its scientists. In its first few decades, the F.D.A. collaborated with scientific societies to develop technical standards for evaluating drugs, standards that have now been emulated worldwide.

    After the thalidomide tragedy of the early 1960s, in which a newly hired medical officer refused to approve the drug in spite of tremendous pressure (it was instead distributed through a clinical testing program), the F.D.A. and the Department of Health and Human Services began to codify these “subdelegation” patterns — that is, giving final say to the F.D.A. — into federal regulation. Federal courts have uniformly upheld these arrangements: they have the sanction of law as well as of scientific practice.

    The possibilities opened by this decision are frightening. A radical pro-business secretary could now, in principle, bypass the clinical trial system and the F.D.A. approval process and decide to approve a drug. A different secretary, one distrustful of the pharmaceutical industry, could stop a drug despite strong scientific support behind it.

    As a result, other countries might easily decide that American drug approval no longer carries scientific weight, hurting our companies’ exports and the international fight against infectious diseases.

    The solution is to do something that many F.D.A. watchers have been proposing for at least a decade: Take the F.D.A. out of the Department of Health and Human Services and make it an independent agency, like the Fed.

    Such an arrangement would give the commissioner a fixed term of six years, dischargeable only for cause. In the same way the president can’t overrule Fed decisions on interest rates, there would be no president or cabinet to overrule the F.D.A.’s decision to approve or deny a drug. (Of course, the Administrative Procedure Act would still apply, and these decisions would still be reviewable on procedural grounds, as they are now, in court.)

    To be sure, an extreme micromanaging president might, in theory, be able to request the resignation of his F.D.A. commissioner to apply political pressure. But with an independent agency he would not be able to hide behind his cabinet secretaries, as President Obama did.

    Critics of this idea will point out that the F.D.A. is equipped to review drugs from a health and safety point of view, not from a moral one. This is a reasonable point. But it doesn’t follow that the secretary or president should have a blanket veto over its decisions. Congress could easily establish a law providing for separate bioethical review.

    At the very least, President Obama and Ms. Sebelius need to clarify what their precedent entails. If they don’t, we can expect to see lobbies from all corners of society — drug companies themselves, safety advocates, groups of doctors and patients — walk directly away from an F.D.A. decision they don’t like and take their cases to the White House.

    We would never allow this sort of second-guessing when it comes to our financial health. We should have the same standards when it comes to our public health.

    Daniel Carpenter is a professor of government at Harvard and the author of “Reputation and Power: Organizational Image and Pharmaceutical Regulation at the F.D.A.”

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