DarshanTalks Podcast
Welcome to DarshanTalks!
We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!
Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do.
We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
DarshanTalks Podcast
Off-Label Risks: Compliance Matters Now More Than Ever
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?
