Criminalizing Knowledge: The Perverse Implications for Off-Label Promotion Prosecutions of the "Intended Use" Regulations


The article examines the "Catch-22" life-science manufacturers are placed in when they know of an off-label use for the products they manufacture.

Off-label use is pervasive in the medical field, in fact, it is often critically important. It can, in certain specialties, represent the standard of care. Drug and medical device manufacturers, however, may only legally promote their product for uses that are approved by the FDA. So, if a manufacturer knows that doctors are putting their products to a use that is not approved by the FDA, they could face criminal exposure.

This is the issue currently being litigated by Allergan in their case against the FDA about Botox. Allergan knows that Botox is being used by doctors to treat a condition called spasticity, in fact they have applied for a new label for that use. The company wants to provide doctors with appropriate dosing information for that use, which would, technically, be a violation of the laws against off-label promotion.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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