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THE LATEST ON GOVERNMENT INQUIRIES AND ENFORCEMENT ACTIONS

Government Investigations and White Collar Litigation Group
Enforcement and Prosecution Policy and Trends

DOJ’s Antitrust Division Announces New Whistleblower Rewards Program

Earlier this week, the Justice Department’s Antitrust Division announced that, for the first time ever, it will offer rewards to individuals who report antitrust crimes and related offenses.

Partnering with the United States Postal Service, the Antitrust Division now invites individuals with original and specific information about antitrust crimes to voluntarily report that information and, in appropriate cases, earn substantial monetary rewards of up to 30% of any criminal fines recovered. While alleged violations must be nominally related to “the Postal Service, its revenues, or property,” whistleblowers need not articulate a material or significant harm to the USPS to be eligible for the program.

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Compliance, Fraud, Deception and False Claims

DOJ and HHS Reestablish False Claims Act Working Group, Delineate Healthcare Enforcement Priorities

On July 2, 2025, the U.S. Department of Justice (DOJ) and U.S. Department of Health and Human Services (HHS) announced they will reestablish the DOJ-HHS False Claims Act Working Group. Originally formed in December 2020 at the tail end of the first Trump administration, this partnership focuses on advancing enforcement of the False Claims Act (FCA) as a primary tool to combat healthcare fraud. While some may view the announcement as merely formalizing long-existing cooperation between DOJ and HHS, the announcement is significant in that it signals the administration’s commitment to investigating and prosecuting individuals and entities that commit healthcare fraud. This reinvigoration of the FCA Working Group aligns with President Donald Trump’s plans to “aggressively” enforce the FCA.

Read on to learn what healthcare entities need to know about the reestablished working group.

Anti-Bribery and Corruption

After a Pause, DOJ’s Updated FCPA Guidelines Focus on Cartels and TCOs, But Corporate Exposure Remains

Executive Summary: On June 9, Deputy Attorney General Todd Blanche issued a memorandum to the Department of Justice’s Criminal Division, outlining the Department’s focus for pending and future FCPA actions.  A day later, Matthew Galeotti, the Head of the Criminal Division, offered more insight into how this administration will approach FCPA investigations and enforcement actions.  Both pronouncements make clear that DOJ will target companies operating abroad who partner with foreign actors, especially those with any connection to cartels or transnational criminal organizations.  The Criminal Division may also focus more on individual misconduct, rather than corporate liability—a welcome change for companies.

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Anti-Bribery and Corruption

Justice Department Issues First Declination Under NSD’s M&A Safe Harbor Policy to Private Equity Firm, Reinforcing Roadmap for Acquiring Firms

On June 16, the U.S. Department of Justice’s (DOJ) National Security Division (NSD) and the U.S. Attorney’s Office for the Southern District of Texas (USAO-SDTX) announced their decision to decline prosecution of White Deer Management LLC (White Deer), a private equity firm that voluntarily disclosed export control and sanctions violations committed by its newly acquired portfolio company, Unicat Catalyst Technologies LLC (Unicat).[1] This is the first public declination issued under NSD’s M&A Safe Harbor Policy, which applies to voluntary self-disclosures involving potential violations of export control, sanctions, and national security laws.[2]

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Enforcement and Prosecution Policy and Trends, Fraud, Deception and False Claims

Order Limiting Strict Liability Has Implications on FDCA Enforcement for Companies, Individuals

On May 9, 2025, President Trump signed an Executive Order titled “Fighting Overcriminalization in Federal Regulations.” The Order seeks to reduce the regulatory burden on Americans and prevent individuals from being criminally penalized for unknowingly violating complex regulations.  In pursuit of these goals, the Order sets forth a policy “generally disfavor[ing]” strict liability crimes.  Agencies are directed to consider “civil rather than criminal enforcement of strict liability regulatory offenses,” with criminal prosecution reserved for cases involving “persons who know or can be presumed to know what is prohibited or required by the regulation and willingly choose not to comply, thereby causing or risking substantial public harm.”  The Order further directs agencies to complete several longer-term tasks, including preparing a report for the Office of Management and Budget containing a list of criminal offenses they or the U.S. Department of Justice (DOJ) enforce, and identifying whether the offenses have a mens rea requirement.

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Fraud, Deception and False Claims

The Risks of Rushing In: A Closer Look at DOJ Criminal Division’s Updated Corporate Enforcement Policy in the Broader Enforcement Landscape

I. Introduction: More Clarity, But Not a Complete Roadmap

On June 10, Matthew Galeotti, the Head of the U.S. Department of Justice’s (DOJ) Criminal Division, delivered remarks at an event hosted by the American Conference Institute,[1] in which he discussed recent updates to the division’s Corporate Enforcement and Voluntary Self-Disclosure Policy (CEP).[2] The revisions mark the new administration’s most detailed articulation to date of what companies can expect when they come forward to disclose misconduct to the Criminal Division. As Galeotti reiterated in his remarks,[3] the new CEP focuses on three core updates: a streamlined voluntary self-disclosure framework, tighter limits on corporate monitorships, and new whistleblower incentives and policies—including a carveout that allows companies to retain eligibility for a declination even when DOJ learns of misconduct through an internal report.

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Fraud, Deception and False Claims

Healthcare Fraud Enforcement in a Second Trump Administration: Trends, Priorities, and Implications

On May 12, 2025, the United States Department of Justice’s (“DOJ”) Criminal Division released a major policy memorandum outlining its enforcement priorities for the upcoming year. Unsurprisingly, the number one priority for the Division was investigating and prosecuting white-collar crimes related to waste, fraud, and abuse—and particularly healthcare fraud. This emphasis on prosecuting healthcare fraud reflects the current administration’s broader goals of eliminating waste in federal programs, such as Medicare, Medicaid, and TRICARE, and ensuring that taxpayer dollars are used efficiently and effectively.

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Fraud, Deception and False Claims, Government Contracts

Supreme Court Declines to Narrow Reach of Federal Fraud Law

On May 22, 2025, the Supreme Court published its opinion in Kousisis v. United States, No. 23-909, 605 U.S. __ (2025), holding that one who induces a victim to enter into a transaction under materially false pretenses may be convicted of federal fraud even without the intent to cause the victim economic loss. In a unanimous decision, the Court upheld the validity of federal fraud convictions when the defendants delivered the full economic value of the deal. This breaks a trend of recent Supreme Court decisions that have more generally limited the government’s ability to prosecute fraud and corruption cases.

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Compliance

FDA to Expand Unannounced Inspections of Foreign Facilities — Manufacturers, Research Firms Should Prepare

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines and other medical products intended for American consumers and patients. The FDA stated that this new inspection strategy will ensure that foreign manufacturers receive the same level of oversight and regulatory scrutiny as domestic companies. Key aspects of the FDA’s plan include:

  • Increased Frequency: The FDA will increase the frequency of unannounced inspections at foreign facilities.
  • Elimination of Double Standard: The FDA stated that the move ensures that foreign manufacturers are held to the same standards and oversight as domestic companies.
  • Exposing Bad Actors and Ensuring Safe Prescription Drugs: The FDA explained that unannounced inspections will help expose bad actors (e.g., those who falsify records or conceal violations) and ensure that every product entering the U.S. is safe, legitimate and honestly made.
  • Increased Enforcement Activity: The FDA emphasized that it is authorized to take regulatory action against any company that attempts to delay, deny or limit an unannounced inspection.

Read on to learn more about the FDA’s new policy and key considerations for stakeholders.

Enforcement and Prosecution Policy and Trends, Fraud, Deception and False Claims, Government Contracts

DOJ Announces Initiative to Use False Claims Act to Investigate DEI Practices

On May 19, 2025, the U.S. Department of Justice’s (DOJ) Deputy Attorney General announced its new Civil Rights Fraud Initiative, which aims to use the False Claims Act (FCA) to investigate and pursue claims against entities that tolerate antisemitism, allow men to enter women’s spaces or compete in female athletic competitions, or engage in unlawful diversity, equity, and inclusion (DEI) practices.

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