The first six months of the second Trump administration brought major changes to the Department of Justice (DOJ), with the department announcing major policy overhauls intended to align federal enforcement officials’ work with the administration’s priorities.

The changes affect a range of criminal and civil enforcement activities undertaken by the DOJ, with special emphasis on new incentives for companies’ self-disclosure of misconduct, reforms to the department’s policies on monitorships, major changes in Foreign Corrupt Practices Act (FCPA) enforcement, shifts in the priority targets identified for scrutiny under the False Claims Act, and enforcement policies that align with some of the administration’s most visible political priorities.

FDA-regulated companies need to be aware of these important shifts in DOJ policies and to reexamine their corporate compliance programs in light of the changes. They also need to keep up with the government’s ongoing enforcement activities to make sure that they are prepared for any scrutiny on the part of FDA and DOJ officials as department and agency priorities continue to evolve.

As always, compliance officials and corporate management at all levels in FDA-regulated companies must stay up to date with the government’s enforcement activity, assess their firms’ risks and the risks faced by individual executives, senior managers and other employees in light of that enforcement activity, and adjust their operations and corporate compliance programs as needed to manage DOJ and FDA enforcement scrutiny effectively.