DarshanTalks Podcast

Send us Fan Mail In this episode, Darshan Kulkarni speaks with Dae Lee about the growing conflict between pharmaceutical manufacturers and pharmacy benefit managers (PBMs) — and how it’s reshaping the U.S. drug supply chain. They unpack the recent dispute involving AstraZeneca, which alleges discrepancies between the number of branded claims submitted by pharmacies through PBMs and the rebates inv...

Send us Fan Mail The FDA has criticized the industry for not taking advertising and promotion seriously and is now cracking down, as evidenced by hundreds of non-compliance letters. This raises the question: if similar scrutiny applied to clinical research, what would stand out first? Likely areas include proper informed consent, accurate recordkeeping, and potential upticks in physician enforceme...

Send us Fan Mail Cosmetics companies must now register both their facilities and products with the FDA under the new MoCRArequirements, a shift from the previous voluntary system. Each facility must register, and product listings — including categories, ingredients, and manufacturing sites — must be submitted and updated annually. Growing companies face challenges in tracking reformulations, rebra...

Send us Fan Mail Darshan discusses the potential role of AI in medicine. He believes fears of AI replacing doctors for diagnosis are currently overblown, as trust in physicians remains crucial. However, he suggests AI could assist with preliminary research tasks, such as reviewing inclusion/exclusion criteria and conducting initial screening. Have you seen AI being used in this manner?  Support th...

Send us Fan Mail Direct-to-Patient (DTP) models are transforming how medications reach patients, moving beyond clinical research into commercial distribution. Originally developed to help rare disease trial participants avoid long travel to research sites, DTP has become a standard solution for improving patient access and convenience. Today, patients can receive small molecules, complex biologics...

Send us Fan Mail Darshan Kulkarni speaks with Thomas Siepka, CEO of HCI Healthcare Consultants, to take a deep dive into the often-misunderstood world of the 340B drug pricing program. Drawing on Siepka’s extensive experience as a pharmacist and healthcare leader, they explore how the 340B program was designed to support covered entities—such as disproportionate share hospitals and federally quali...

Send us Fan Mail In this conversation, Edye Edens with Nyssa Towsley from UNLV, examine how today’s shifting funding landscape is reshaping IRB operations. Historically, IRBs were built around the assumption that most research would be government-funded. That assumption is being challenged, with changes in funding priorities and availability beginning to influence the volume and nature of submissi...

Send us Fan Mail In this video, Darshan discusses recent enforcement trends show three weak spots to watch: Encounter Quality – If prescribers are just checking boxes without real patient relationships, it’s not care—it’s exposure. Demand documented standards, ID proofing, intake, decision support, and supervision. Don’t take claims at face value—audit them. Cash Flow Logic – Murky subscription fe...

Send us Fan Mail In this episode, Darshan Kulkarni talks with Thomas Siepka about the 340B program, rebates, and the crucial role of pharmacy benefit managers (PBMs) in today’s healthcare system. Siepka, a pharmacist and CEO of HCI Healthcare Consultants, shared his extensive experience working across health systems, community health centers, and tribal healthcare organizations. They break down th...

Send us Fan Mail  In the episode of a new series on academic medical centers, Edye Edens of Kulkarni Law Firm sits down with Cortni Romaine of Florida Atlantic University (FAU) to explore how compliance offices in academia create programs that others aspire to emulate. Cortni explains FAU’s proactive approach to compliance, emphasizing the importance of partnerships both within the university and...

Send us Fan Mail In one of the largest recent Medicare fraud cases, Peter Roussonicolos, a Florida durable medical equipment (DME) company owner, was sentenced to 12 years in federal prison for orchestrating a scheme that defrauded Medicare of more than $61 million. Here’s how the scheme worked: Hidden Ownership: Roussonicolos used straw owners to disguise his true role in several DME companies, e...

Send us Fan Mail The FDA has recently stepped up its enforcement of pharmaceutical advertising rules, issuing 100 cease-and-desist notices and thousands of letters. These notices were largely non-personalized and intended as general guidance, emphasizing that drug advertisements must not create misleading impressions. While such enforcement has always been possible, this renewed effort signals inc...

Send us Fan Mail Darshan Kulkarni and Edye Edens launch an exciting new episode, focusing on the unique challenges academic medical centers (AMCs) face in securing funding in an ever-changing political and regulatory environment. Unlike independent or commercial sites, AMCs operate at a different scale, often managing millions of dollars in government-funded research while navigating complex admin...

Send us Fan Mail Darshan Kulkarni and Edye Edens are kicking off a brand-new video series diving into the unique world of academic medical centers (AMCs) in clinical research. While KLF has long worked with sponsors, CROs, and independent sites, AMCs bring their own challenges: complex operations, unique funding models, layers of compliance, and requirements like investigator-initiated trials that...

Send us Fan Mail Edye Edens and Darshan Kulkarni share the origin story of KLF and explain what makes working with licensed attorneys different from hiring non-legal consultants. They highlight three key advantages: Privilege & Confidentiality: Legal privilege means attorneys must keep client information confidential indefinitely—offering stronger protections than standard NDAs. Broader Strate...

Send us Fan Mail Telehealth and pharma are facing some of their biggest compliance challenges yet—and the latest enforcement actions prove regulators aren’t slowing down. On one side, the FTC is investigating Hims & Hers, a popular telehealth company, over allegations of misleading advertising and unfair cancellation practices. This case highlights how patient-facing companies must tread caref...

Send us Fan Mail Darshan Kulkarni and Edye Edens examine whether sponsors should provide feedback to clinical trial sites on why they were selected—or not—for a study. While it is technically possible for sponsors to share this information, they caution that doing so carries significant risks. These include liability concerns, potential miscommunication, and the practical challenge of managing fee...

Send us Fan Mail AI is no longer a distant concept in pharma marketing—it’s here, transforming campaign design, review, and distribution. CEOs and CMOs face a critical question: Can I safely integrate AI into my marketing toolkit? AI offers speed, cost savings, precise targeting, and scalable personalization. Yet, it introduces significant risks, including data ownership, opaque algorithms, halluc...

Send us Fan Mail Edye Edens and Darshan Kulkarni from KLF discuss the pros and cons for clinical trial sites considering becoming backup sites. Key points include: Sponsor Perspective: Signing up as a backup site can give first access to trials and increase the likelihood of being selected, especially since not all primary sites meet recruitment targets. Sponsors may expect some commitment, includ...

Send us Fan Mail 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. Pharmac...

Send us Fan Mail 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 manag...

Send us Fan Mail 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 cros...

Send us Fan Mail 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,...

Send us Fan Mail 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, th...

Send us Fan Mail 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 involvin...