Friday, February 20, 2009


POff-Label Promotion and "Closet Deregulation"

The NYT reports two guilty pleaas by former Stryker sales reps for off-label promotion.

Without getting into the particulars of this case, it does seem that off-label prosecution is coming thick and fast. The record verdicts agaist Lilly/Zyprexa a few weeks ago, the even larger verdict against Pfizer/Bextra (announced on the day of the Wyeth buy), and now this smaller case.

As many of you know, the same folks who fight for FDA preemption are generally also fighting for looser (or non-existent) off-label promotion guidelines. The irony is not subtle. On the one side, we must always defer to FDA's "scientific expertise." Except in those instances when it we opt to ignore it.

This recent case seems especially egregious in that the off-label use was not only unapproved but, allegedly, dangerous in the application for which it was being promoted.

In any event, preemption used to be called "closet tort reform." We can now be clear that it is "closet deregulation" as well -- and neither aspect is in much of a closet.


  1. Justice good one sentence summary of the convoluted thinking involved in these issues -

    "On the one side, we must always defer to FDA's "scientific expertise." Except in those instances when it we opt to ignore it."

    Also see this article - Feds Look to Extend Off-Label Marketing Streak With J&J

    The Feds are on a mission. I expect we will see the Preemptors coming out against off label practices.

  2. Someone must have said, “Send in the Clowns,” or was it “Give a clown an inch and he’ll take a mile?” At any rate, there’s nothing funny about these clowns.

  3. In general, preemptors are have been the same folks who have wanted to "liberalize" or completely eliminate limiting off-label promotion. See the history of Washington Legal Foundation, et. al.

    This is would their logic would be:

    Sometimes "optimal" regulation is no regulation. Then they would talk about how long it took FDA to officially say that Bayer could claim aspirin was useful in preventing heart attacks and strokes. Then there would be reference to the zillions of people who needlessly died because, not having heard this from Bayer, they suffered in cardiac ignorance about all that aspirin might do for them. (Certainly, there's no chance they would have heard anything from any source.)

    And the beat goes on.

  4. Another off-label bust...

    Click on "Peanut brittle" for the rest of the story.

  5. Johnson & Johnson has been busted.


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