DarshanTalks Podcast
Welcome to DarshanTalks!
We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!
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We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
DarshanTalks Podcast
Your DEI Program Could Trigger an FCA Case
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.
