Medical Product Off-Label Use and Marketing – Webinar Recording/Transcript
Medical Product Off-Label Use and Marketing: How to Conduct an Internal Investigation
What would you do if faced with alleged violations of the False Claims Act or the Food, Drug and Cosmetic Act?
Off-label marketing can land drug and devicemakers in dangerous waters. Your company must have a solid process for compliance with current law and guidance as well as SOPs to detect potential wrongdoing and address possible whistleblower claims.
Mark Levy, Esq. — a litigator and trial attorney who is an expert in defending companies in alleged criminal and civil violations of the False Claims Act and the Food, Drug and Cosmetic Act — is here to share his knowledge of compliance regarding off-label marketing with you.
- An overview of the current law and guidance on off-label promotion and how it affects quality, regulatory and compliance professionals.
- An overview of compliance to detect potential allegations of wrongdoing and how to deal with them.
- Understand the nuances of the False Claims Act, which is used as a tool by whistleblowers to make civil false claims allegations for alleged unlawful off-label promotion.
- How the First Amendment intersects with claims relating to off-label use.
- How to conduct an effective internal investigation when alleged unlawful off-label promotion is detected or a whistleblower’s claims are learned.
Be prepared: This presentation will provide you with a clear understanding of how to put a compliance process in place and how to conduct an effective internal investigation should the need arise.