Enforcement in Life Sciences Series

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement in Life Sciences Series:

Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers

About the Enforcement in Life Sciences Series

Recent settlements between the U.S. Department of Justice (DOJ) and a range of FDA-regulated drug and medical device manufacturers provide a snapshot of the DOJ’s enforcement focus. These settlements involve new DOJ theories of liability or new ways of evaluating long-standing industry practices, and may be harbingers of future DOJ enforcement activity. In this six-part series of client alerts, we take an in-depth look at the facts and legal theories in each case or set of cases, discuss what makes each novel, and consider the compliance implications for each. 

Part 1: DOJ Introduces Novel Theories of Liability and Requires Unprecedented Controls in Speaker Program Settlement
April 21, 2021

Our first edition tracks the more expansive lens and stringent controls developing around speaker programs.

Part 2: DOJ’s Evolving Enforcement Approach to Off-Label Promotion
April 27, 2021

The second installment of this series looks at the DOJ’s evolving enforcement approach to off-label promotion.

Part 3: Navigating Relationships With Practice Support and Other Tech Vendors
May 4, 2021

The third installment of the series explores the compliance risks that health care manufacturing companies can face in vendor arrangements featuring new technology options.