Medical Product Off-Label Use and Marketing – Webinar Recording/Transcript

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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.

Presentation Takeaways:

  • 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.

  • Compliance Officers
  • Consultants/Service Providers
  • Executive Management
  • General/Corporate Counsel
  • Investigators
  • Managers
  • Manufacturing Directors and Supervisors
  • Regulatory/Legislative Affairs Professionals
  • Risk Management Specialists
  • Sales/Marketing Personnel
  • Strategic Planning and Business Development Staff

Mark Levy, Esq., a litigator and trial attorney with Eckert Seamans, has represented Fortune 500 companies in complex commercial litigation in state and federal forums across the country. He has spent most of his career defending pharmaceutical and medical device companies and manufacturers of products in heavily-regulated industries in claims made by federal, state and local law enforcement agencies. Corporations and individuals charged with violations of federal criminal law often turn to Mr. Levy for guidance. He has handled investigations into alleged criminal and civil violations of federal statutes and regulations, including the False Claims Act and the Food, Drug and Cosmetic Act. He has also conducted internal investigations, from routine to serious, for companies in the pharmaceutical and medical device industries. Mr. Levy regularly provides risk-management advice to businesses that manufacture and sell products for consumer use. This includes developing, expanding and implementing corporate compliance programs in highly regulated environments, evaluating risk exposure to toxic tort litigation and assessing the risks of litigation costs in complex, multi-party litigation. His interest in risk management and corporate defense began prior to his joining private practice, when he was the lead paralegal for Ford Motor Company in the civil and criminal defense of Ford arising from alleged product defects in the Ford Pinto automobile. Mr. Levy has provided counsel to many businesses seeking to assess or avoid claims risk. He has also counseled pharmaceutical and medical device companies as well as other manufacturers on product recalls.