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
- 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?