This article was published in the Summer 2023 issue of the Food and Drug Law Institute’s Update magazine, pages 3 through 7. It can be downloaded through the link at right or read online.
In February and March of 2023, the U.S. Department of Justice (DOJ) announced significant policy updates affecting a broad range of businesses, including those regulated by the U.S. Food and Drug Administration (FDA). The first concerns the specific circumstances under which DOJ will not seek a guilty plea from a company that voluntary self-discloses misconduct. The second addresses how, when evaluating the adequacy of corporate compliance programs, DOJ assesses executive compensation structures as well as company policies on the use of messaging applications and personal devices to conduct company business. Both updates implement revisions to DOJ’s corporate criminal enforcement policies first announced in a September 2022 memorandum by Deputy Attorney General Lisa Monaco (Monaco Memorandum).
The authors recommend that FDA-regulated entities become familiar with DOJ’s newly announced “carrots and sticks,” and consider incorporating them into their own policies and procedures.