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