Investigations, Enforcement, & Compliance Alerts

The annual False Claims Act (FCA) recovery statistics issued by the U.S. Department of Justice for Fiscal Year 2024, coupled with the Trump administration’s focus on the elimination of waste, fraud, and abuse in government spending and apparent intentions to rely on the FCA to pursue other administration priorities, signal a likely increase in FCA investigations and actions throughout 2025 and beyond.

Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued guidance to clarify how firms in a product distribution chain, including manufacturers and distributors, should establish voluntary-recall initiation procedures that ensure timely identification and notification of and responses to product problems.