Understanding and Adapting to New Guidance Regarding the Parameters of Conversation and Dissemination of Information Regarding Off- Label Use of Medical Devices

March 11, 2015 4:45pm

Anne K. Walsh
Hyman, Phelps & McNamara PC

Darren W. Alch
Vice President, General Counsel & Compliance Officer
Cyberonics, Inc.

  • What the FDA Draft Guidance means for medical device promotion
    • Best practices to update your salesforce training program
    • Necessary adjustments to be made to your controls for your outside contracted sales team
    • When, where, and how you can distribute medical publications
  • Does the First Amendment still protect that right to distribute as it was deemed in WLF v. Friedman?
    • How does this translate overseas?
  • Managing your salesforce and FCA exposure
    • What happens when your sales team instructs providers to utilize a device in a context that can lead to overbilling?
    • Analyzing the consequences of Medtronic Spine and the kyphoplasty settlements
    • Balancing that fine line of medical device sales and playing doctor
    • Warranty issues
  • What can we expect from promised FDA further guidance?