Preparing for the Pharma Fraud Enforcement Surge

Partners John Kelly and Jacquelyn Papish co-authored an article for pharmaphorum entitled "Preparing for the Pharma Fraud Enforcement Surge."

The article noted that pharmaceutical companies can no longer treat compliance as a check-the-box exercise with Department of Justice False Claims Act (FCA) settlements and judgments reaching a record-breaking $6.8 billion in fiscal year 2025.

"Approximately $5.7 billion of that total stemmed from healthcare matters, with $3.7 billion arising from enforcement actions against pharmaceutical companies and pharmacies," they wrote. "The latter figure includes the largest FCA judgement in history, which arose from whistleblower allegations that an international pharmaceutical company submitted false and misleading prescription drug claims to federal healthcare programmes."

The authors drew from Barnes & Thornburg's recent Healthcare Enforcement and Compliance Report to analyze the areas where the government is scrutinizing pharmaceutical companies most intensively and how to mitigate enforcement risks in the year ahead.

"As the size of average enforcement settlements continues to climb, the cost of an inadequate compliance programme has never been clearer," the authors wrote. "In this enforcement landscape, proactive, risk-based compliance is no longer a catchphrase – it is the decisive factor in mitigating government enforcement exposure and preserving organizational resilience."