In early December 2025, the U.S. Department of Justice (DOJ) quietly launched a dedicated Health & Safety Unit (HSU) within the Criminal Division’s Fraud Section. Announced through the publication of a new unit website on December 2, 2025, this development marks a significant step in centralizing the DOJ's efforts to prosecute corporate misconduct that endangers patient health, consumer safety, or worker well-being.
For those of us who advise healthcare organizations—hospitals, pharmacies, device manufacturers, pharmaceutical companies, and distributors—this isn't just another organizational change. It's a clear signal that safety-related lapses, particularly when intertwined with elements of concealment or falsification, are increasingly likely to attract criminal scrutiny. The HSU builds on the recent dissolution of the Civil Division's Consumer Protection Branch, transferring seasoned prosecutors to bolster criminal enforcement capabilities.
Understanding the Unit's Focus and Reach
At its core, the HSU targets criminal violations involving the Food, Drug, and Cosmetic Act (FDCA) and related statutes, general Title 18 provisions, such as conspiracy under 18 U.S.C. § 371, mail/wire fraud under 18 U.S.C. §§ 1341/1343, false statements under 18 U.S.C. § 1001, as well as Consumer Product Safety Act (CPSA) — (15 U.S.C. §§ 2051 et seq.), particularly for failures to report product defects or hazards that pose substantial risks of injury or death, and Federal Hazardous Substances Act (FHSA) — (15 U.S.C. §§ 1261 et seq.), which addresses misbranded or banned hazardous substances. Some target areas include:
Adulterated, misbranded, or counterfeit drugs, devices, and other products
Issues with data integrity, such as falsified adverse event reports or traceability records
Systemic failures that conceal or perpetuate safety risks
In practice, this translates to heightened attention on everyday operations in healthcare settings:
For pharmacies and compounding facilities, risks may arise in areas like inventory controls, counterfeit detection, and dispensing protocols.
Hospitals and clinics could face exposure related to device tracking, adverse event reporting, or safety concerns tied to off-label use.
Manufacturers and distributors should be mindful of labeling, certification processes, and supply chain oversight.
What stands out is the potential for these issues to escalate beyond civil or administrative penalties. When there's evidence of false statements, obstruction, or conspiracy under Title 18, the path to criminal charges becomes more direct.
A Collaborative and Data-Driven Approach
One aspect that many in the industry are watching closely is the HSU's emphasis on interagency partnerships. The unit is designed to work hand-in-hand with the FDA, U.S. Attorneys’ Offices, and other agencies like the Consumer Product Safety Commission. This coordination often means that a single incident can spark parallel civil and criminal investigations—a scenario we've seen play out in complex cases before.
Moreover, being housed alongside the established Health Care Fraud Unit (with its team of over 80 prosecutors and advanced data analytics capabilities) creates natural synergies. Safety violations linked to fraudulent billing, unusual prescribing patterns, or manipulated documentation could quickly draw combined resources from both units.
The focus on individual accountability is another key element. As with broader DOJ policies, executives and employees involved in decision-making may find themselves personally in the spotlight, alongside corporate resolutions like deferred prosecution agreements or monitorships.
Steps Healthcare Organizations Can Take Today
In our experience working with clients navigating regulatory challenges, proactive steps make all the difference. Here are some practical recommendations to consider:
Perform a Focused Risk Assessment
Review processes around safety data integrity, adverse event reporting, and quality systems to identify potential vulnerabilities.
Strengthen Integration of Safety and Compliance
Ensure that product safety and quality controls are fully woven into your broader fraud and compliance programs, with regular training for staff on reporting obligations.
Update Incident Response Plans
Prepare for the possibility of coordinated investigations by refining protocols that protect privilege, facilitate internal reviews, and evaluate options for voluntary self-disclosure under DOJ guidelines.
Audit Critical Areas
Prioritize reviews of high-exposure processes, such as traceability, clinical data management, and third-party relationships.
Engage Cross-Functional Leadership
Involve legal, compliance, quality assurance, and clinical teams in discussions about these evolving priorities to foster a unified approach.
Looking Ahead
The creation of the Health & Safety Unit underscores the DOJ's ongoing commitment to protecting public health through robust enforcement. While the unit is still new, it reflects a broader trend toward treating serious safety shortcomings—especially those involving deception—as criminal matters worthy of dedicated resources.For healthcare leaders, this is a timely reminder to reinforce governance structures not just to mitigate risks, but to uphold the trust patients place in us every day. Strengthening these practices now can position your organization more resiliently in the face of scrutiny.
At MDRXLaw, we regularly assist clients with enforcement defense, compliance program enhancements, internal investigations, and strategic advice on DOJ matters.
If you'd like to discuss how the Health & Safety Unit might impact your operations or request an assessment of your current preparedness, please reach out to our Healthcare Enforcement Defense team at info@mdrxlaw.com or visit mdrxlaw.com. We're here to help navigate these developments with practical, tailored guidance.
