DarshanTalks Podcast

Off-Label Risks: Compliance Matters Now More Than Ever

June 03, 2024 Darshan Kulkarni
Off-Label Risks: Compliance Matters Now More Than Ever
DarshanTalks Podcast
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DarshanTalks Podcast
Off-Label Risks: Compliance Matters Now More Than Ever
Jun 03, 2024
Darshan Kulkarni

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? 


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Show Notes

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.