Off-Label Marketing On Shaky Ground

Law360, New York (June 4, 2008, 12:00 AM EDT) -- The U.S. Department of Justice’s (“DOJ”) prosecution of pharmaceutical and medical device companies for alleged off-label marketing and the Food and Drug Administration’s (“FDA”) recent attempt to provide parameters for such marketing means that now, more than ever, pharmaceutical and medical device companies must be wary of the promotional materials they provide doctors.

Currently, the DOJ is investigating more than 150 drug and medical device manufacturers for alleged off-label promotions. The consequences for manufacturers accused of off-label marketing can be significant.

Last year, Pfizer Inc. paid...
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