An Evolving Approach to Enforcement in the Life Sciences Sector

This program presented by Avia Dunn, counsel at Skadden, Arps, Slate, Meagher & Flom LLP, and Alexandra Gorman, counsel at Skadden, Arps, Slate, Meagher & Flom LLP, will explore recent enforcement trends against pharmaceutical and medical device manufacturers by the government's primary enforcers: (1) DOJ; (2) FDA; and (3) HHS-OIG. This course will analyze the types of civil and criminal cases the government is choosing to prosecute, examine trends in FDA enforcement, including DOJ's enforcement strategy regarding off-label, and explore the evolution of OIG's use of Corporate Integrity Agreements. 

Learning Objectives: 

1. Review recent enforcement actions 

2. Identify recent enforcement trends

3. Discuss compliance and risk management considerations to address the DOJ's and FDA's evolving approach to enforcement