DarshanTalks Podcast

Send us Fan Mail 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 exp...

Send us Fan Mail 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...

Send us Fan Mail 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 s...

Send us Fan Mail 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...

Send us Fan Mail 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...

Send us Fan Mail 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 (...

Send us Fan Mail 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 patien...

Send us Fan Mail 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 v...

Send us Fan Mail 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) tra...

Send us Fan Mail 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 reportin...

Send us Fan Mail 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...

Send us Fan Mail 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 p...

Send us Fan Mail 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...

Send us Fan Mail 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 integ...

Send us Fan Mail 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, ove...

Send us Fan Mail In this episode, Edye and Darshan dive into the controversial but critical question: Are we paying patients enough to participate in clinical trials? And if not, how can we ethically and compliantly pay them more? Key Takeaways: The Coercion Concern  Compensation for trial participation is often scrutinized by IRBs due to concerns around coercion. Historically, this concern stems...

Send us Fan Mail Google’s 2024 ad safety report just sent shockwaves through the pharma and device industries. With AI now faster, smarter, and more ruthless, Google blocked over 5.1 billion ads last year and restricted 9.1 billion more. Healthcare ads were hit especially hard, with over 106 million healthcare and medicine ads being blocked. If you’re still relying on old review systems or outdate...

Send us Fan Mail In this episode Edye Edens and Darshan Kulkarni tackle a hot-button issue in clinical trials: Should all screen fails be paid for? The discussion was sparked by a recent wave of community questions and contract examples around this very topic. From the sponsor’s perspective, concerns center around cost control and compliance. Sponsors fear that paying for every screen fail, withou...

Send us Fan Mail In this episode, we explore a crucial and timely issue: how the Trump administration’s approach to antitrust enforcement—combined with new state-level regulations—is creating a shifting legal environment for life sciences companies, especially those involved in mergers and acquisitions (M&A). At the federal level, Assistant Attorney General Gail Slater, in her first major anti...

Send us Fan Mail Transferring medical device ownership during a company sale requires careful planning to ensure compliance and operational continuity. The process begins with accurate documentation of 510(k) clearance and thorough due diligence to avoid regulatory delays. Next, companies must assess ongoing clinical trial responsibilities and contractual obligations tied to the device. Compliance...

Send us Fan Mail At first glance, responding to site-level findings seems simple—but when Edye and Darshan dug into the details, it became clear that the lines of responsibility blur fast. Here's how each side sees it: Site Perspective: Sites know the boots-on-the-ground reality. When a finding is made—especially during an external inspection like the FDA—they’re often the ones best positione...

Send us Fan Mail Medical communications teams must exercise caution when using websites dedicated to medical affairs, as legal risks go beyond overt sales promotion. Drug and device manufacturers face compliance challenges, particularly when these platforms are accessed by broader audiences, including non-scientists. Key risks include: Off-Label Promotion: The Facteau case highlights how communica...

Send us Fan Mail At the Save Our Sites (SOS) conference, many site owners expressed excitement over finally having a space to openly discuss real challenges—budgets, pricing, contracting, and the isolation of being a site owner. While the intent was mutual support, concerns quickly arose when some attendees began advocating for standardized pricing across sites (e.g., "$200 for an X-ray"...

Send us Fan Mail The recent conviction of a Michigan pharmacist and his brother in a $15 million healthcare fraud scheme highlights the growing crackdown on pharmacy-related fraud. The scheme involved billing for medications that were never dispensed, targeting Medicare, Medicaid, and private insurance. This pattern of fraud is not new, as the Department of Justice (DOJ) recently charged nearly 20...

Send us Fan Mail Pharma is finally catching up to the on-demand world—offering direct-to-patient (DTP) services that promise convenience, faster delivery, and a more personalized experience. Major players like Pfizer, Lilly, and Novo Nordisk are leading the way, cutting out intermediaries like pharmacists, PBMs, and even traditional physicians. But convenience comes at a cost. By removing these sa...