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

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.