Off-Label Usage

Off-label usage of drugs and medical devices accounts for a large percentage of profits yet also presents a minefield of potential legal, regulatory, ethical, and financial problems. To make matters worse, the regulatory and legal landscape has become more varied and confusing in recent years as organizations such as the DOJ, the OIG, and more have become involved. Here’s a chance for you to learn everything you need to know about this difficult topic in one easy stop.

This conference addresses the following issues (and more):

·         Understanding and complying with the FDA on off-label issues

·         Knowing who regulates off-label issues other than the FDA—and what you need to comply with

·         Using your First Amendment Rights to communicate valuable information

·         Proactive steps to take to minimize your off-label risks and avoid costly penalties

·         Transforming off-label data into valuable on-label information

·         Training your sales force on off-label issues: What to do, and what not to do

·         Maximizing your Medicare and Medicaid reimbursements while avoid penalties