1. EachPod

Off-Label Risks: Compliance Matters Now More Than Ever

Author
Darshan Kulkarni
Published
Mon 03 Jun 2024
Episode Link
None

We shed light on the complexities surrounding off-label promotion and reimbursement in the pharmaceutical industry.


We discuss the following:

  1. What does off-label mean from a reimbursement standpoint? 
  2. Lessons from the US v. Eli Lilly 2009 case 
  3. How do recent court decisions impact off-label promotion? United States v. Caronia and US v. Facteau 
  4. How are weight loss drugs, initially approved for treating diabetes, reimbursed within Medicare and Medicaid? 
  5. How are compounded drugs reimbursed? 
  6. Could a company be held accountable for off-label use of a drug due to
  7.  compounded products? 
  8. Are weight loss drugs exempted from reimbursement? 


Support the show

Share to: