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  • Jack Dreyfus, FDA Reform Pioneer

    April 10, 2009
    My colleague John Berlau wrote a nice obituary of mutual fund pioneer Jack Dreyfus that was published in Investor's Business Daily earlier this week. One thing John points out that few readers are likely to have known about Dreyfus is his long-time advocacy of more liberal FDA regulation of off-label drug promotion. FDA has the statutory authority to regulate promotional materials distributed by pharmaceutical companies about their products, and the agency imposes a near-total ban on distributing information about unapproved, or so-called off-label, uses. Once FDA approves a drug for any indication, doctors are free to prescribe it for any other use. The practice is so widespread that an estimated 60 percent of all...
  • Baptist-Bootlegger Alliance on Tobacco

    April 8, 2009
    In today's Washington Examiner, Tim Carney has an excellent column on how the bill to place tobacco under FDA regulation would reduce competition in the tobacco industry and enrich the biggest company -- Philip Morris -- at the expense of consumers and competitors alike. Although the bill is supported by leading anti-smoking groups (which indirectly receive money from Big Tobacco through the $246 billion Master Settlement Agreement), the bill's...
  • Virginia Postrel on Her Own Brush with Cost-Effective Drug Research

    April 1, 2009
    One letter writer argues that Herceptin was a poor example because "Multiple cost-effectiveness analyses have shown that, despite its high cost, Herceptin is both effective and cost-effective." That, of course, was Postrel's point. She replies, "its very cost-effectiveness makes it such a striking example. New Zealand chose to ration the drug (and not to cover it at all for early-stage cancer until July 2007) despite its significant benefits."
  • Fishing for Rationality in the Beauty Salon

    March 23, 2009
    Thinking of getting one of those cool new “fish pedicures”? Well, you’d better act fast. 14 states have already banned the process. But a member of the Ohio State Board of Cosmetology says, “It seemed to me it was very sanitary, not sterile of course." But, “[s]anitation is what we’ve got to live with in this world, not sterility.”
  • An Explosion of Litigation

    March 13, 2009
    Already burdened by $8 trillion in new federal spending commitments and the likelihood of higher taxes to pay for bailouts, pork, and welfare, the economy now faces an additional threat: an explosion of litigation. Even liberal Washington Post...
  • Yes, "Botch" is the right word.

    March 5, 2009
    Alex is right. “This IS one of these questions about what to do in the real world, where first-best solutions just aren’t politically possible†(emphasis added). So, I think it’s reasonable for we libertarians to support the less bad position that, if our society is going to create a regulatory gatekeeper for drugs and empower it to make risk-benefit balancing decisions on our behalf, then we should not permit lay juries to ratchet up that regulation in circumstances in which all reasonably available information about risks and benefits is internalized into the system.
  • Did the Supreme Court "Botch" Wyeth v. Levine?

    March 5, 2009
    I was initially going to post this as a comment to Greg Conko's recent post arguing against the Court's recent decision in Wyeth v. Levine, but the comment system didn't work correctly for me. I appreciate the force of Greg's argument (and I certainly agree that this particular case should have been decided much earlier on different grounds), but I think there is room for reasonable disagreement within the libertarian community about whether FDA preempting state tort law is good or bad. This is one of these questions about what to do in the real world, where first-best solutions just aren't politically possible. Most libertarians would likely agree that there should be only one...
  • Supreme Court Botches Preemption Case

    March 4, 2009
    Ms. Levine alleged not only that the warning on Phenergan's label wasn't strong enough, but that Phenergan was "not reasonably safe for intravenous administration," and that Phenergan's label should have indicated that the drug "should not be used intravenously." But, that's a question regarding FDA's approval of the product for that use, not merely the sufficiency of the warning.
  • Obama's Bankruptcy Math Has to be Wrong

    February 25, 2009
    President Obama claimed in his speech tonight:
    "For that same reason, we must also address the crushing cost of health care. "This is a cost that now causes a bankruptcy in America every thirty seconds."
    This number can't be true.  A bankruptcy every 30 seconds would be equal to 120 bankruptcies per hour.  Multiply that by 24 hours in a day and 365 days in a year (presuming a non-leap year), and you get 1,051,200 bankruptcies per year. This numbers seems a little high, even considering that 2008 was a year with a lot of a bankruptcies.  But there's a reason that number seems high.  Namely, it's not true. According to Zacks Investment Research:
    "During 2008, personal bankruptcies had the most significant increase since the major...
  • Wyeth v. Levine: Policy Arguments Regarding Preemption

    February 13, 2009
    The Wyeth v. Levine case presents a narrow set of facts in which the Food and Drug Administration had, for many years, known about the risks presented by intravenous push injection of Phenergan and worked with the manufacturer to carefully word the label description of this risk. Nevertheless, disregarding the limiting facts in the Levine case, a flood of “friend of the Court†pleadings supporting Ms. Levine sought to broaden the preemption debate and persuade the Court of the critical need for additional tort-based supervision of the pharmaceutical industry.

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