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.