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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

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 Edye breaks down three common pitfalls sponsors face: Lagging confirmatory trials Outdated safety monitoring plans Poor communication across teams and with FDA ...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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6:12

NIH Grant Denials Ruled Discriminatory?

DarshanTalks Podcast ·

2025/07/08

Darshan Kulkarni and Edye Edens break down a recent federal court ruling that challenges the NIH’s decision to halt grant funding for projects focused on LGBTQ+ populations and DEI-related research. The judge ruled that cutting off funding solely on a discriminatory basis—such as the subject matter being DEI or LGBTQ+ related—may itself be unconstitutional. While this has sparked optimism among affected researchers, Edye and Darshan caution that this is just one step in a longer legal process...

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1:31

Are Speaker programs supposed to be salesy?

DarshanTalks Podcast ·

2025/07/04

Pharmaceutical speaker programs come in two forms: one aimed at promoting a product, and another focused purely on education. Both must be compliant, but many companies blur the lines—leading to billion-dollar fines. Government bodies like the OIG consider these programs “inherently suspect” unless strict criteria are met. To stay compliant, speakers must have relevant expertise (not just high prescription rates), and every presentation is vetted by a Medical-Legal-Regulatory (MLR) team. Desp...

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2:52

DTP Compliance Just Got Tricky

DarshanTalks Podcast ·

2025/06/28

The Seventh Circuit just issued a pivotal decision in U.S. v. Sorenson, reshaping how pharmaceutical and medical device companies should think about direct-to-patient (DTP) advertising and Anti-Kickback Statute (AKS) compliance. In this case, Sorenson’s company paid marketers to generate patient interest in orthopedic braces reimbursed by Medicare. These marketers gathered patient details and sent unsigned prescriptions to physicians. While most leads went nowhere, the court ruled this did no...

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12:39

Should You Use AI to Draft Informed Consent?

DarshanTalks Podcast ·

2025/06/26

Darshan Kulkarni and Edye Edens discuss the potential and pitfalls of using AI—like ChatGPT—to draft informed consent documents in clinical research. With both legal and regulatory expertise, they explore how AI could save time, whether it fits institutional IRB requirements, and the real-world value (or lack thereof) for different types of organizations. Key Takeaways: Drafting vs. Final Use: AI can be useful as a first-draft tool, especially for high-volume sponsors. But using it for final ...

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2:41

Could You Survive a Surprise Pharmacy Audit?

DarshanTalks Podcast ·

2025/06/23

Imagine you're filling a script when a State Board of Pharmacy inspector walks in—no warning, just a clipboard and serious consequences. Most community pharmacists assume, "That won’t happen to me," but audits are no longer rare—they're the norm. Controlled substances are under intense scrutiny. Inspectors now expect airtight records, ongoing (not one-time) training, and SOPs that reflect current laws—not ones from 2019. If you’re relying on outdated policies, verbal explanations, or friendly...

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9:39

Self-Reporting in Clinical Trials

DarshanTalks Podcast ·

2025/06/20

In this video, Edye Edens and Darshan Kulkarni discuss whether sponsors, sites, CROs, or IRBs should self-report compliance issues. Edye, who focuses on sites, explains that whether or not to self-report is highly situation-dependent. Some situations legally require reporting, while in others, organizations might have room to implement corrective actions without immediate reporting—but they must carefully understand applicable regulations and enforcement trends. Darshan highlights the distinc...

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3:40

$14M Fine Says This “Free” Offer Wasn’t Legal

DarshanTalks Podcast ·

2025/06/18

In this must-listen episode for pharma marketers and corporate counsel, we break down the recent $14.25M False Claims Act settlement involving Diopsys, a neurodiagnostic company accused of offering free tech to physicians—tech that allegedly led to medically unnecessary tests billed to Medicare and Medicaid. This wasn’t just bad billing—it was a marketing strategy gone wrong. The DOJ saw it as a kickback scheme, and the case highlights how well-meaning “value-add” services can turn into legal...

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11:50

Nonprofit Pharma Exists. Here is how it works

DarshanTalks Podcast ·

2025/06/16

In this episode, we talk to Martin Van Trieste about Civica Rx, nonprofit pharmaceutical company designed to address drug shortages in the U.S. The company focuses on sterile generics and biosimilars that have become economically unviable for other manufacturers. Initially operating as a broker, Civica transitioned into manufacturing, filing multiple ANDAs monthly and building a plant in West Virginia capable of producing 200 million doses annually. Civica's mission-driven approach includes t...

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263 results

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