The First Amendment and Off-Label Enforcement: Understanding the Impact of the Caronia/Amarin/Pacira/ Vascular Solutions Cases on the Medical Device and FDA-Related Industries

July 21, 2016 1:30pm

Michael Pauze
King & Spalding LLP

Mona Patel
Covington & Burling LLP

  • Background and update on the cases
  • How are these cases affecting FDA’s ability to regulate what companies can say?
  • What is FDA doing? What is Congress doing?
  • Will these cases really destroy FDA’s pre-approval authority?
  • What are the next steps to take based on the current status of the cases?