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

Written by John Oroho | May 21, 2007 5:05:00 AM

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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