Can Prosecutors Use Data from Sample Distribution as Evidence of Off-Label Promotion?

May 21, 2007

By John Oroho


In an era of increased scrutiny and large settlements, zealous prosecutors will undoubtedly use novel methods to pursue pharmaceutical manufacturers. One area that has received significant attention is off-label promotion. According to the Food, Drug and Cosmetic Act, if a pharmaceutical manufacturer promotes its product for uses other than those included in the FDA-approved label, that manufacturer has engaged in off-label promotion, which “misbrands” prescription drugs and is expressly prohibited.

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