FDA to hold public hearing on off-label communication

FDA will hold a public hearing on Nov. 9 and 10 to obtain input from stakeholders on off-label communication of FDA-approved medical products. The agency is seeking input on the standards that should be applied to minimize the potential of off-label communications "to be misleading or otherwise cause harm," as well as input on what information companies need to disclose in off-label communication to ensure it is truthful and not misleading.

FDA also is seeking input on how increased communication about unapproved uses could affect public health and patient incentives to enroll in clinical trials, and whether off-label information from third parties affects how companies communicate about unapproved uses. ...