On Demand

An Evolving Approach to Enforcement in the Life Sciences Sector

1h 1m

Created on June 15, 2021





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

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