DarshanTalks Podcast

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). Wh...

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:

1. High Prescribers – Is the KOL being compensated for research or for prescribing power?

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 institution...

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:

1. Lagging confirmatory trials
   
   
2. Outdate...

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 go...

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 regulator...

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...