DarshanTalks Podcast

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...

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...

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 roo...

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, ...

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 bot...

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....

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 a...

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 bec...

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 Darsha...

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 presenta...

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 physician...

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 to...

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 fr...

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 regu...

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 highlig...

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 milli...

In this discussion, Joseph Wolfson, an attorney at Stevens and Lee, and Darshan explore the intersection of law, marketing, and compliance in the pharmaceutical and medical device industries. Joe focuses on both antitrust litigation and advising private equity firms, pharmaceutical companies, and medical device companies on legal matters, particularly around unfair competition and antitrust concerns.

Joe explains how his firm helps ...

In this episode, Darshan Kulkarni and Edye Edens explore whether sites should consider whistleblowing on non-compliant sponsors. They acknowledge that non-compliance is a non-negotiable issue, but emphasize the difficulty of deciding when to report, especially given the financial and relational ties between sites and sponsors.

They discuss examples, like overpayments or data integrity violations, which might compel a whistleblower t...

In this episode, Darshan Kulkarni sits down with Marie Ange Noue, Senior Director and Head of Scientific Communications at EMD Serono, to dive deep into the increasingly common practice of medical affairs teams creating dedicated LinkedIn handles.

Marie explains that this trend is driven by healthcare professionals’ evolving preferences for receiving medical information—today, over 70% prefer digital formats, and more than 50% use L...