Responding to Unsolicited Requests for Off-Label Information

A conversation with Darshan Kulkarni, Principal Attorney, Kulkarni LLC, focusing on the recent Citizen Petition filed with the FDA by seven major pharmaceutical companies asking for new regulations regarding the dissemination of off-label product information and other communications with healthcare professionals.

Questions/Topics To Be Discussed

• Provide an overview of the petition.
• Why Guidance vs regulation, which is best for pharma? Why does petition specifically ask for new regulations? What's the first amendment repercussions?
• Considering that FDA is currently working on guidance regarding unsolicited requests for information (online and offline), what impact does this have on FDA's guidance timeline?