Darshan Kulkarni breaks down the Department of Justice’s new Civil Rights Fraud Initiative, launched on May 19, 2025, and why it should be on the radar of every pharmaceutical and medical device company. Under this initiative, the DOJ plans to use the False Claims Act (FCA) to pursue organizations that knowingly violate civil rights laws while receiving federal funds—including R&D grants, Medicare/Medicaid payments, or other government contracts.
The discussion highlights how DEI programs, supplier diversity efforts, and patient outreach initiatives—though often well-intentioned—can raise legal risks if they assign benefits or burdens based on protected traits like race or gender. Companies certifying compliance with civil rights obligations must ensure their practices truly align with federal requirements, or they risk triggering FCA liability. Darshan outlines concrete steps to update compliance programs: conducting audits, vetting DEI policies, documenting legal justifications, training internal teams, strengthening reporting systems, and preparing a response plan.
This episode is essential listening for in-house counsel, compliance officers, and executives navigating DEI and ESG obligations in a tightening regulatory landscape.
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