Sharing off-label information in the digital environment

21st May 2012 by Sally Leon

This blog post has been created to support a tweetup that the medDigital team are conducting for an upcoming PIPA Conference workshop.

Off-label information relates to information about the use of prescription drugs for unapproved indications, patient groups, doses or formulations. Pharma have a valuable role to play in sharing accurate and up to date information, including off-label information, about their products with HCPs and organisations providing patient care.

With conversations about those products happening online and in public forums, it is critical that pharma understand how and when it is appropriate for them to participate.

Late last year, the FDA issued draft guidance on how pharma should respond to requests for off-label information received via digital media, a summary of which can be found in our previous blog - In a nutshell: FDA draft guidance.