Medical Devices


Off-label Advertising for Medical Devices

Companies are often trying to address the needs of prescribers. These needs often show up as off-label questions. As it presently exists, life science companies can engage in off-label discussions provided that the conversation occurs in one of 4 safe harbors that have traditionally been non-promotional.





Evolving Role of Medical Affairs

Medical Affairs, and MSLs have traditionally been the only individuals within a life science company who can engage in discussions about the off-label uses of a product. This role has, however been challenged by the Caronia, Amarin and Pacira decisions that question whether only Medical Affairs can provide such information. In light of the court decisions companies have questioned whether Medical Affairs may, in the future, be combined with the sales force to effectively become “super sales reps”. This would, however, be a mistake.

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