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‘Who Is The Arbiter?’ US FDA Asks As It Mulls Loosening Off-Label Reins

 
• By Derrick Gingery

A drumbeat of court cases – and now a change in presidential administrations – signals that regulations on off-label communications need to change; but FDA still seems unsure how to relax its grip without letting go completely.

FDA may be willing to consider loosening the regulations on manufacturer communication of off-label uses, but is concerned about how it could maintain oversight. During a Nov. 9 public hearing on the subject, several industry representatives made free speech and other constitutional arguments in favor of FDA allowing sponsors to give truthful and non-misleading information about unapproved, or off-label, uses of their products.

Some agency officials in attendance, however, seemed concerned about how it would be determined whether information meets the desired standard.

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