DarshanTalks Podcast
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 medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
Are Pharma Chatbots Putting You at Regulatory Risk?
Pharmaceutical chatbots are increasingly used to answer patient drug questions, but they carry significant regulatory and compliance risks. While the FDA has issued guidance on AI in drug development and medical devices, it does not yet provide a framework for patient-facing drug Q&A. That means chatbots that discuss side effects, dosing, or interactions exist in a gray zone, and any missteps could trigger FDA enforcement.
The FTC enforces truth in advertising and consumer protection. Misleading claims, impersonating a doctor, or offering unverified information can lead to investigations. Some states, like Illinois, Nevada, Utah...
Are Your Cosmetic Company Records Ready for FDA Audits?
Companies must maintain thorough records to meet FDA inspection requirements, including safety substantiation files, labeling proofs, ingredient documentation, and adverse event logs. Adverse event logs must be retained for six years (three for small businesses), while registration and product listing records require annual updates. Organized, accessible, and up-to-date records are essential not only for compliance but also for growth, due diligence, and investor confidence. Compliance is a strategic asset: clean, well-maintained files position a company as scalable and acquisition-ready, turning regulatory diligence into a competitive advantage.
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When Medical Affairs Becomes Commercial in Disguise
Darshan explores a critical question for life sciences companies: is your medical affairs team truly independent from commercial—or are you just pretending?
In this episode of KLF Deep Dive, Darshan highlights why organizational charts alone are not enough to satisfy regulators. He explains that regulators focus on conduct, process, and intent, not PowerPoint slides. Using the 2013 GlaxoSmithKline settlement as a cautionary example, he demonstrates how blurred lines between medical and commercial functions contributed to a $3 billion resolution. Advisory boards, medical information responses, and even scientific exchanges were scrutinized because they appeared promotional rather th...
Serious Adverse Event Reporting Under MoCRA
Under the Modernization of Cosmetics Regulation Act (MoCRA), reporting serious adverse events to the FDA is now mandatory. Companies must report serious incidents—such as hospitalizations, infections, disfigurement, or medically treated allergic reactions—within 15 business days. They must also maintain records of all adverse events for six years (or three years for small businesses).
Practically, this requires setting up a system to capture and assess customer complaints, determine seriousness, and document actions taken. Beyond compliance, this serves as a safety and trust mechanism—helping protect consumers, prevent regulatory actions like warning letters or recalls, and st...
Key SOPs for Clinical Trials
Darshan Kulkarni highlights that to stay compliant with the FDA, companies don’t need an exhaustive set of SOPs—just the essential ones. Inspectors primarily focus on SOPs covering informed consent, adverse event reporting, drug/device accountability, source documentation, PI oversight, protocol deviations, and record retention. He emphasizes keeping SOPs concise, practical, and enforceable, training staff consistently, and expanding them only as operational needs grow.
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Payer Presentations Can Trigger Enforcement
The boundary between scientific exchange and marketing in payer presentations is increasingly blurred, creating significant compliance and enforcement risks. While payers demand real-world evidence, comparative studies, and economic models beyond FDA-approved labeling, manufacturers must ensure all shared information is truthful, non-misleading, properly contextualized, and backed by competent and reliable scientific evidence.
Key pitfalls include:
Cherry-picking data without balanced limitations.Economic models presented without caveats or assumptions.
Future indications framed as imminent rather than investigational.
Crossing into promotion can trigger FDA...
Pharmacies v manufacturers
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 invoiced by those PBMs. The issue shines a spotlight on how PBMs control formulary access and drug distribution, often requiring manufacturers to pay hefty rebates to ensure their products are covered — a “pay-to-play” model that impacts pharmacies, patients, and drug p...
Is Clinical Research Ready for the new FDA?
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 enforcement. While this use of AI in research compliance hasn’t fully emerged yet, AI is already being applied in promotion oversight and will likely accelerate compliance monitoring. Industry now needs to identify and tighten key processes to stay ahead as AI scales enforcement....
Is your cosmetics company FDA-registered?
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, rebrandings, or acquisitions, as missing updates can trigger FDA enforcement or product removal. To scale safely, companies should register early and implement a repeatable compliance process.
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Will AI Replace Doctors in clinical research?
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?
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Risks in Direct-to-Patient Engagement
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, and even medical devices directly at home, making what was once exceptional now routine.
Despite the benefits, DTP introduces significant operational and regulatory challenges. Compliance is complex because different states have different rules for pharmacy shipments, and FDA promotion rules still apply to delivered...
Inside 340B: Challenges, Controversies, and Opportunities
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 qualified health centers—by requiring manufacturers to provide steep discounts. These savings allow organizations serving large underinsured and uninsured populations to “stretch scarce federal resources” and reinvest in patient care and community programs.
The conversation unpacks the registrati...
IRBs in 2025: What’s Really Changing?
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 submissions.
At UNLV, for example, faculty research submissions show a slight dip in volume and a change in character. With fewer grants available, complex multi-site or multi-cohort studies may give way to more pilot projects and smaller-scale research that can be...
3 Red Flags in Telemedicine Partnerships
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 fees, misuse of facility fees, or volume-driven compensation are red flags. Require transparent fee schedules, fair market value memos, and ongoing monitoring.
Referral Data Architecture – Patient steering crosses compliance lines. Keep education...
What do PBMs do?
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 the complex healthcare landscape, explaining the distinction between health insurance companies and PBMs. PBMs specialize in managing the medication component of insurance programs, handling everything from claims processing and formulary management to manufacturer negotiations and rebate administration. Initially, PBMs we...
How AMCs Build Stronger Compliance Cultures Together
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 across the state. At FAU, new federal, state, or institutional requirements are reviewed collaboratively by compliance, research integrity, sponsored programs, general counsel, and other key offices to ensure smooth implementation. Beyond the campus, FAU participates in...
How One DME Scheme Cost Medicare $61 Million
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, evading disclosure requirements and regulatory oversight.Illegal Kickbacks: He arranged payments to marketers and telemedicine providers in exchange for patient referrals, blatantly violating federal Anti-Kickback Statute provisions.
FDA to Step Up Enforcement on Pharma Advertising
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 increased regulatory attention, particularly on direct-to-consumer marketing.
Historically, FDA enforcement letters have trended downward, partly due to stronger First Amendment protections for off-label promotion. The Trump administration highlighted this issue through a presidential memorandum calling for a step-up in enforcement, though some observers see this...
Top 5 Factors Determining AMC Funding
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 administrative structures, compliance layers, and internal politics. Edye, drawing from her 10 years inside a major AMC, shares firsthand insights into the heightened sensitivity surrounding controversial research topics, the impact of presidential and state-level funding shifts, and the pressures of maintaining compliance and operational efficiency under intense...
New Series Drop: Exploring AMCs in Clinical Research
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 don’t exist elsewhere. As Edye—drawing from 10 years inside a major AMC—explains, these environments operate at a different pace and scale, and often face resource strains even as they generate critical innovation and patient impact.
D...
Why Choose a Licensed Attorney Over a Consultant?
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 Strategic Scope: Lawyers approach problems with a strategic lens, integrating legal, operational, and regulatory considerations before offering advice, often working alongside consultants for execution.
Duty to Client’s Best Interests: Attorneys are legally bound to prioritize the client’s best i...
Marketing Problems by Hims & Hers and Lilly
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 carefully when making claims about access, outcomes, or subscription services. The FTC’s involvement signals that “growth hacking” in healthcare has limits—and consumer protection laws apply just as strongly in digital health as anywhere else.
On the other si...
Should Sponsors Share Site Feedback?
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 feedback when dozens of sites may be competing for the same study.
Darshan and Edye note that while most trials—such as common therapeutic areas like hypertension, diabetes, or general oncology—offer little incentive for sponsors to provide detailed...
AI Marketing Playbook for Drug Companies
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, hallucinated content, and potential FDA violations. Accountability for AI-generated content remains a key concern—vendors, marketing teams, or executives may all be at risk.
Some companies are proactive: implementing bias audits, ethical guardrails, contractual protections, and va...
Should Sites Be Ready on Standby?
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, including potential startup or maintenance costs while waiting.Site Perspective: Some sites may worry about being seen as “second choice,” but having the capability to quickly operationalize a trial is a valuable skill. Site...
Eastern District of PA Targets Pharmacies
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. Pharmacy owners must strengthen compliance programs, maintain accurate inventory records, and conduct early audits—before regulators come knocking.
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Telehealth Done Right
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 management contracts safe harbor.
This matters for pharma, digital therapeutics, and connected device companies increasingly partnering with telehealth platforms. The opinion clarifies that digital marketing services promoting physician practices can be paid for—if structured correctly. Key compliance factors include fair mar...
DOJ and HHS Launch FCA Fraud Task Force
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 cross-agency task force is laser-focused on tightening enforcement and closing regulatory loopholes across the life sciences sector. Key targets include:
Clinical Trials: Fraud related to consent forms, fabricated data, improper enrollment, and documentation mismanagement.Promotional...
Should Sponsors Cover Malpractice Insurance?
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, justifying full coverage through a single trial is difficult.
Darshan pushes back, suggesting that including malpractice in overhead feels like “nickel and diming” for what is a baseline cost of doing...
Instagram Post that Sparked FDA Warning Letter
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, the post wasn’t submitted to the FDA via Form 2253 as required. This isn’t Sprout’s first offense; the FDA previously cited them in 2020, and repeat misbranding is now considered a public health risk.
Darshan emphasizes that for pharma marketing teams and legal depart...
Why Are So Many Doctors Getting Arrested?
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 involving an alleged $14.6 billion in healthcare fraud. From fake telemedicine visits to unnecessary prescriptions and kickbacks for referrals, this case isn't just about shady backroom deals. It includes major hospital systems, pharmacy chains, and telehealth plat...
How to Run Compliant Pharma Speaker Programs
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). While both are legal, they must be executed with extreme care. Regulatory bodies like the OIG and FDA have repeatedly called these programs “inherently suspect,” especially when the lines between...
Are You Picking the Wrong KOLs?
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:
High Prescribers – Is the KOL being compensated for research or for prescribing power?Influencer Effect – Are they being used to sway other physicians’ prescribing behavior?
They also highlight issues with KOL selection...
How KLF’s Client Base Evolved Over 20 Years
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 independent and commercial sites.
Importantly, Darshan shares how compliance, once an afterthought in the industry, has b...
FDA Pushback on Accelerated Gene Therapy Approvals
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 trialsOutdated safety monitoring plans
Poor communication across teams and with FDA
She offers practical guidance to avoid regulatory setb...
Your DEI Program Could Trigger an FCA Case
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, supplier diversity efforts, and patient outreach initiatives—though often well-intentioned—can raise legal risks if they assign benefits or burdens...
Teva’s Charity Partnership Scrutinized
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, ensuring transparency and compliance to avoid financial penalties and reputational harm. Conducting due diligence, seeking legal guidance, and structuring agreements carefully are essential steps to mitigate...
Is There a “Right” Way to Calculate FMV?
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 we know they’re not all overpaying?” That central question becomes the backdrop for a broader conversati...
Can Non-Physicians Own Clinical Trial Sites?
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 research sites that involve clinical procedures requiring medical judgment, diagnosis, or treatment.
A common misconception is that clinical trials ar...
The KLF Story You Haven’t Heard
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 building something better than the traditional legal mold.
Da...
