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PODCAST

DarshanTalks Podcast

Darshan Kulkarni

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!Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do.We focus on life science issues involving

science life sciences

All Episodes

0:43

Eastern District of PA Targets Pharmacies

DarshanTalks Podcast ·

2025/08/21

The Eastern District of Pennsylvania has ramped up False Claims Act enforcement against pharmacies, with cases ranging from multi-million dollar settlements to outright bans on dispensing controlled substances. Coupled with the DOJ-HHS False Claims Act Working Group and a record-breaking national healthcare fraud takedown, the message is clear: enforcement is accelerating. Pharmacy owners must strengthen compliance programs, maintain accurate inventory records, and conduct early audits—before...

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3:32

DOJ and HHS Launch FCA Fraud Task Force

DarshanTalks Podcast ·

2025/08/18

The Office of Inspector General (OIG) recently issued an advisory opinion approving a telehealth business model where a management company leases clinicians and provides backend services—like scheduling, billing, and digital marketing—to a separate physician practice. While this setup might raise anti-kickback concerns, OIG says it’s compliant under the personal services and management contracts safe harbor. This matters for pharma, digital therapeutics, and connected device companies increas...

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6:20

DOJ and HHS Launch FCA Fraud Task Force

DarshanTalks Podcast ·

2025/08/15

In Fiscal Year 2024, whistleblower cases reached an all-time high of 979, signaling increased scrutiny of healthcare fraud. Just days after announcing a massive $14.6 billion healthcare fraud takedown involving 324 defendants, the Department of Justice (DOJ) and Department of Health and Human Services (HHS) launched a False Claims Act (FCA) Working Group on July 2, 2025. This cross-agency task force is laser-focused on tightening enforcement and closing regulatory loopholes across the life sc...

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4:13

Should Sponsors Cover Malpractice Insurance?

DarshanTalks Podcast ·

2025/08/13

Darshan and Edye tackle a hot topic in clinical research budgeting: Should malpractice insurance be considered an overhead cost that sponsors cover? Edye explains both sides. Sponsors often argue that malpractice is simply a cost of being a physician, unrelated to research. Sites, however, may try to include it—at least partially—as part of trial-related overhead. But even then, justifying full coverage through a single trial is difficult. Darshan pushes back, suggesting that including ...

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4:44

Instagram Post that Sparked FDA Warning Letter

DarshanTalks Podcast ·

2025/08/11

In this episode, Darshan Kulkarni unpacks the May 29, 2025 FDA Warning Letter issued to Sprout Pharmaceuticals. The trigger? A promotional Instagram post from the company's CEO calling Addyi “the sex pill for women,” highlighting benefits but completely omitting the serious risks—like hypotension, syncope, alcohol interactions, and contraindications. To make matters worse, the post wasn’t submitted to the FDA via Form 2253 as required. This isn’t Sprout’s first offense; the FDA previously cit...

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4:26

Why Are So Many Doctors Getting Arrested?

DarshanTalks Podcast ·

2025/08/09

Why are headlines suddenly filled with stories of doctors, nurses, healthcare executives—and even accountants—being arrested for fraud? In this explosive episode of Daran Talks, we dive into what the Department of Justice is calling the largest healthcare fraud takedown in U.S. history. In July 2025, federal authorities charged 324 individuals in a sweeping investigation involving an alleged $14.6 billion in healthcare fraud. From fake telemedicine visits to unnecessary prescriptions and kick...

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7:54

How to Run Compliant Pharma Speaker Programs

DarshanTalks Podcast ·

2025/08/06

What really happens behind the scenes of pharmaceutical speaker programs—and why should smaller pharma companies care? In this episode of DarshanTalks, Darshan Kulkarni unpacks one of the most misunderstood but highly scrutinized parts of pharma marketing: speaker programs. These programs typically come in two forms—promotional (to raise product awareness and encourage prescribing) and educational (such as accredited CME events). While both are legal, they must be executed with extreme care. ...

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4:28

Are You Picking the Wrong KOLs?

DarshanTalks Podcast ·

2025/08/04

Darshan Kulkarni and Edye Edens tackle the complexities of identifying and working with Key Opinion Leaders (KOLs) in clinical research. While KOLs can bring valuable expertise to a therapeutic area, simply labeling someone as a KOL—especially when they self-identify—can raise significant compliance concerns. They unpacks two major red flags: High Prescribers – Is the KOL being compensated for research or for prescribing power? Influencer Effect – Are they being used to sway other physicians...

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5:13

How KLF’s Client Base Evolved Over 20 Years

DarshanTalks Podcast ·

2025/08/02

Edye Edens interviews Darshan Kulkarni about the evolution of the Kulkarni Law Firm (KLF). Darshan reflects on how he originally envisioned working with large pharmaceutical and device companies, but over the past 15–20 years, the firm has expanded to support not only pharma, but also law firms, consulting companies, and research sites. They discuss how the clinical research landscape has shifted—from a focus on academic institutions and big players to a broader ecosystem that includes indepe...

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4:10

FDA Pushback on Accelerated Gene Therapy Approvals

DarshanTalks Podcast ·

2025/07/31

In this episode, Edye Edens dives into the FDA’s evolving scrutiny of accelerated approvals in gene therapy and rare diseases. Using the example of Sarepta’s muscular dystrophy treatment, she explains how postmarket safety issues and incomplete confirmatory trials can put previously celebrated approvals under renewed FDA evaluation. Edye breaks down three common pitfalls sponsors face: Lagging confirmatory trials Outdated safety monitoring plans Poor communication across teams and with FDA ...

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6:04

Your DEI Program Could Trigger an FCA Case

DarshanTalks Podcast ·

2025/07/30

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...

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2:20

Teva’s Charity Partnership Scrutinized

DarshanTalks Podcast ·

2025/07/28

A recent $425 million settlement involving Teva Pharmaceuticals highlights the legal and ethical risks charities face when partnering with pharmaceutical companies. Teva was accused of using a charity to cover patient co-pays, a tactic intended to boost drug sales, leading to serious legal consequences. While pharma funding can provide essential resources for charities, it also raises concerns about indirect kickbacks and regulatory scrutiny. Charities must rethink their engagement strategies...

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12:50

Is There a “Right” Way to Calculate FMV?

DarshanTalks Podcast ·

2025/07/25

Darshan Kulkarni and Edye Edens take a deep dive into one of clinical research’s most persistent questions: how is fair market value (FMV) actually determined for clinical trial sites—and who gets to decide? Building on the previous discussion about whether all sites should be paid the same, this episode unpacks the complexity behind FMV calculations. Darshan shares an anecdote involving a DOJ official questioning the credibility of FMV data derived from industry benchmarks, asking: “How do w...

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3:35

Can Non-Physicians Own Clinical Trial Sites?

DarshanTalks Podcast ·

2025/07/23

Can non-physicians own independent clinical trial sites? The answer isn’t as simple as it seems. In most states, including Texas, engaging in clinical research is considered the practice of medicine, which means that research sites must adhere to the same rules that apply to medical practices. This includes the corporate practice of medicine doctrine, which restricts ownership and control of medical practices to licensed physicians. As a result, non-physicians generally cannot own or manage r...

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8:35

The KLF Story You Haven’t Heard

DarshanTalks Podcast ·

2025/07/20

In this special episode, Senior Attorney Edye Edens sits down with Darshan Kulkarni, founder and principal of the Kulkarni Law Firm, for a personal and honest look at how the firm came to be. Darshan shares how the firm was born in the shadow of the 2008 financial crisis—at a time when job security was shaky and entrepreneurship felt more like a risk than an opportunity. What started as a leap of faith became a 15+ year journey rooted in intentionality, versatility, and a deep belief in build...

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6:05

Why Telehealth Platforms Are Getting Sued

DarshanTalks Podcast ·

2025/07/17

We explore the growing wave of class action lawsuits hitting the telehealth industry—and why legal counsel, especially those advising telemedicine platforms or navigating pharma partnerships, must pay attention now. Here’s the core issue: many ad tech stacks are leaking protected health information (PHI) through tracking pixels and cookies. These tools—common in e-commerce—are transmitting sensitive data to third parties like Meta, potentially without proper consent. That’s not a glitch; it’s...

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12:21

Should Clinical Trial Sites Be Paid Differently?

DarshanTalks Podcast ·

2025/07/15

In this episode of the KLF Deep Dive, Darshan Kulkarni and Edye Edens engage in a practical discussion around one of the most debated issues in clinical research: Should clinical trial sites be paid differently based on who they are, where they’re located, or what they bring to the table? The conversation challenges the idea of flat-rate, standardized budgets for all sites and explores the concept of Fair Market Value (FMV) from both sponsor and site perspectives. Edye and Darshan break down ...

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5:46

How to Build an AI Compliance Program

DarshanTalks Podcast ·

2025/07/14

In this episode of KLF Deep Dive, Darshan Kulkarni explores the growing urgency for in-house counsel to develop AI compliance programs as artificial intelligence becomes embedded in drug discovery, clinical decision-making, patient engagement, and beyond. Darshan emphasizes that AI can create significant legal risk—even without breaking the law—if companies fail to address issues of transparency, validation, privacy, and governance. As regulators like the FDA and FTC tighten their expectation...

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5:06

What the Big Beautiful Bill Means for Trial Sites

DarshanTalks Podcast ·

2025/07/11

Darshan Kulkarni and Edye Edens examine the far-reaching implications of the newly passed “Big Beautiful Bill”—a sweeping piece of legislation tied to the Trump administration’s political agenda. While the bill itself does not directly reference clinical research, Darshan and Edye highlight how its provisions—particularly the reduction in Medicare and Medicaid funding—could have serious downstream effects on clinical trial access and site viability. Edye raises concerns that the legislation m...

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1:51

Co-Pay Mistakes Can Trigger DOJ Action

DarshanTalks Podcast ·

2025/07/09

In Alvarez v. Lincare, the Eleventh Circuit highlighted a growing risk for pharma marketers and legal teams running Direct-to-Patient (DTP) campaigns. Lincare and Optigen were accused of defrauding the government by: Routinely waiving co-pays without documenting financial hardship, Shipping unrequested supplies, Allegedly paying kickbacks to boost business. While most claims were dismissed—not because they weren’t serious, but due to insufficient specifics—the upcoding charges remained. Wh...

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331 results

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