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.
Our first edition tracks the more expansive lens and stringent controls developing around speaker programs.
The second installment of this series looks at the DOJ’s evolving enforcement approach to off-label promotion.
The third installment of the series explores the compliance risks that health care manufacturing companies can face in vendor arrangements featuring new technology options.
The fourth installment of this series identifies growing attention by U.S. regulatory officials on the obstruction of FDA inspection activities, specifically those related to data integrity and especially in certain parts of the world, as a risk to patient health and safety.
The fifth installment of the series analyzes regulatory risks to companies in financial relationships with physicians who can purchase, prescribe or recommend their products; in-kind transfer practices that may raise compliance issues; and controls for administering joint marketing programs.
The sixth and last installment of our Enforcement in Life Sciences Series examines underreporting risks related to the Centers for Medicare & Medicaid Services’ Open Payments Program (the Sunshine Act). Enforcement agencies are taking a closer look at reporting by life sciences companies and have signaled that increased scrutiny is likely in the future. Such companies should pay particular attention to reporting requirements applicable to companies and organizations affiliated with health care professionals.