REMS: Requirements, Regulation, and Enforcement - Webinar Recording/Transcript
REMS: Requirements, Regulation, and Enforcement — Evolution from Safety Program to Enforcement Tool
REMS has evolved into a powerful enforcement tool.
Last year there were to significant settlements involving a manufacturer’s failure to comply with REMS strategies.
The Novo Nordisk settlement resulted in disgorgement of $12 million and a payment of $46.5 mill to resolve the False Claims Act liability.
The settlement by Aegerion contained both criminal and civil components. On the criminal side, the company admitted two misdemeanor violations of the FD&C Act, and agreed to pay $7.2 million in criminal fines and forfeiture. The company also entered into a Deferred Prosecution Agreement with the government to resolve charges of conspiracy to violate HIPAA. The civil settlement included a $28.8 million payment for False Claims Act violations, a Corporate Integrity Agreement, and a Consent Decree of permanent injunction.
FDAnews has called on Anne K. Walsh, a Washington, D.C., attorney to discuss why the REMS evolution has occurred and how to prepare for future changes. Her presentation alerts you to likely regulatory and legislative changes ahead in coming months, and positions you for better compliance. You’ll learn about:
- The recently changed requirements evolving REMS from a safety initiative to a powerful enforcement tool
- How to protect your company from enforcement actions and strategies for defending an enforcement
- The most successful strategies to defend against a False Claims Act case based on compliance with safety requirements
- Recent settlements and what they mean
- How to prevent a Deferred Prosecution Agreement with the government to resolve charges of conspiracy to violate HIPAA
Failure to prepare for REMS changes could result in penalties — civil, and even criminal ones. Don’t take that risk.