DOJ Criminal Division unveils major shifts in white-collar crime enforcement

Companies that voluntarily self-report wrongdoings will receive benefits that are now recognized in policy change.

The head of the DOJ’s Criminal Division, Matthew R. Galeotti, delivered remarks recently that stressed the division’s response to administration-directed orders as well as updated guidelines reflecting this response.

While much of recent focus has been on efforts that secure American interests on broad scale, perhaps the most consequential change for pharmaceutical compliance officers is the DOJ’s new guarantee of declinations for companies that voluntarily self-report misconduct, cooperate with investigations, and remediate issues.

“The benefits to companies that voluntarily self-report, cooperate, and remediate have never been clearer and more certain: those companies will receive a declination, not just a ‘presumption,’” Galeotti said. “I am closely reviewing all corporate resolutions, and I am standing behind this policy.”

This represents a major incentive for companies discovering internal wrongdoing, though the DOJ maintains some flexibility where “aggravating factors” exist.

Galeotti offered stark words for companies that don’t take advantage of the benefits the division is offering for cooperating companies. “This is the time for companies to self-report. It is the time to do the work, come in early, cooperate, and remediate,” he continued. “The Criminal Division's policies give clear benefits to those who do.”

Monitor requirements recalibrated

Galeotti outlined the approach to corporate monitors.

“Monitors are meant to be a temporary bridge and accountability measure to move a company quickly and efficiently to full compliance,” Galeotti explained. “We believe the measures we’ve instituted in place of monitorships—including putting additional burden on the Criminal Division—more quickly transition companies to full compliance.”

This shift away from traditional monitoring arrangements could reduce compliance costs while placing greater emphasis on internal controls and self-directed remediation efforts.

Galeotti also addressed the following recent changes in the division:

Accelerated Investigations Demand Rapid Response — “Lengthy and sprawling investigations do not serve the Department, our prosecutors, the American public, or those under investigation,” the Division stated. This efficiency mandate extends to companies under investigation, with clear expectations: “Producing documents swiftly in response to requests, promptly identifying key evidence, quickly making witnesses available, and effectively navigating complex global legal regimes are just part of what we expect cooperating companies to do.”

Foreign Corrupt Practices Act Enforcement Guidelines focus on cases that “vindicate U.S. interests,” which Galeotti clarified to mean conduct that “genuinely impacts the United States or the American people.” For pharmaceutical companies operating in markets with elevated corruption risks, this recalibration requires careful assessment of global compliance programs and potential exposure.

Expanded Whistleblower Program — The division has expanded its Corporate Whistleblower Awards Pilot Program, which Galeotti said has already generated new tips across multiple categories including healthcare fraud.

Learn more about current policies impacting the pharmaceutical compliance community.

Header image: Depositphotos@ alancrosthwaite