Category: CME

Medical Devices

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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.

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MLR

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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.

Disclaimer: The opinions stated in this blog are the sole and present opinions of the blogger and do not necessarily represent the opinions of the Kulkarni Law Firm, PC and/or its attorneys. Such opinion(s) may change over time. Such opinion(s) should not necessarily be attributed to the institution for which these individuals may work or otherwise represent in any capacity. These blogs do not constitute legal advice and should not be construed as such.

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