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DOJ's Evolving Enforcement Approach to Off-Label Promotion | 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. ....

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DOJ Announces Concrete Company's Deferred Prosecution Agreement: Are Effective Antitrust Compliance Programs Really Less Important Now? Unlikely. | Vinson & Elkins LLP

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In early January 2021, the U.S. Department of Justice’s (“the DOJ”) Antitrust Division (“the Division”) announced a Deferred Prosecution Agreement (“DPA”) with Argos USA LLC (“Argos” or “the Company”).
1 While DPAs have been used to resolve prosecutions in other Divisions of the DOJ, the Antitrust Division has considered DPAs only since a policy shift in 2019. Under the new policy, DPAs were to be applied in limited situations where a company committed an antitrust crime despite having an effective compliance program. Division leadership has further suggested that the compliance program in place at the time of the antitrust violation would need to be robust and thoughtful, and that DPAs would be considered only for companies that self-reported misconduct. ....

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