The May 12, 2025, memo from the head of the Department of Justice’s (DOJ’s) Criminal Division highlights 10 “high-impact” areas as the focus of DOJ’s criminal enforcement efforts. (See our May 14, 2025, client alert “In a New Memo, DOJ Outlines White Collar Crime Focus Areas and Prosecutorial Guidance.”) At least three of these areas should seem familiar to businesses subject to civil investigation and enforcement under the False Claims Act (FCA).
DOJ’s list includes the following priority targets:
- “Waste, fraud, and abuse, including health care fraud and federal program and procurement fraud that harm the public fisc” — the first priority on the list.
- “Trade and customs fraud, including tariff evasion” — the second priority on the list.
- “Violations of the Controlled Substances Act and the Federal Food, Drug, and Cosmetic Act (FDCA), including the unlawful manufacture and distribution of chemicals and equipment used to create counterfeit pills laced with fentanyl, and unlawful distribution of opioids” — another item on the list.
All of these are central focuses of DOJ’s attention under the FCA. Theories of fraud in health care and government contracts, as the Criminal Division’s first priority describes, are historical cornerstones of FCA enforcement, regularly generating hundreds of millions of dollars of civil recoveries annually for the government.
The Criminal Division’s second priority, meanwhile, follows a new area of government attention under the FCA: Since earlier this year, DOJ has publicly indicated that it intends to devote significant effort and resources to policing fraud in applications of customs laws with the FCA.
And the Criminal Division’s attention to opioid distribution not only continues a long-running pattern in its prosecutorial work but also echoes FCA enforcement efforts across recent years targeting the drug distribution chain, from opioid manufacturers to prescribers to, most recently, dispensing pharmacies. The efforts potentially signal an expanded focus on other actors, including equipment manufacturers.
The Criminal Division’s priorities may reflect how DOJ views civil FCA liability and criminal penalties as traveling hand in hand in high-priority areas. Entities subject to federal health care program rules, U.S. customs laws, opioid regulations and other government requirements subject to FCA investigatory scrutiny may find that criminal prosecutorial efforts now run parallel to those investigations.
At a minimum, these announced priorities, coupled with the significant changes made to DOJ’s enforcement policies regarding self-disclosure, cooperation and remediation, underscore the critical ongoing importance of a nimble and robust compliance system and carefully considered interpretations of the law in highly regulated industries. A misstep now may carry an even heavier penalty than it has in the past. (See also “DOJ Unveils White Collar Enforcement Overhaul: New Incentives, Streamlined Policies and Expanded Whistleblower Rewards.”)
This memorandum is provided by Skadden, Arps, Slate, Meagher & Flom LLP and its affiliates for educational and informational purposes only and is not intended and should not be construed as legal advice. This memorandum is considered advertising under applicable state laws.
For further information, please contact:
Avia M. Dunn, Partner, Skadden
avia.dunn@skadden.com
