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Considerations When Disseminating Off-Label Information

By Alan Minsk and David Hoffman

How is the dissemination of information regarding an unapproved indication for an approved drug or medical device like speeding on the highway? You might not get caught, but it can be dangerous and it might land you in court.

Most pharmaceutical and medical device companies promote their products for unapproved ' or off-label ' uses. The term “off-label” as used in this article refers to a situation in which the Food and Drug Administration (FDA) has approved or cleared the sale of a product for a particular indication, but a company markets it for a different use. Companies can make millions of dollars on off-label sales and, in some cases, the sales associated with off-label use are more profitable than sales associated with the authorized indication. Off-label promotion is a business reality. However, gains from off-label promotions can be quickly offset by costs associated with product liability litigation and the loss of good will within the medical and consumer communities.

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