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.
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...
Why Telehealth Platforms Are Getting Sued
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, potentially without proper consent. That’s not a glitch; it’s a design feature—and it may violate HIPAA, the FTC Act, CCPA, and state consumer protection laws.
Key Legal...
Should Clinical Trial Sites Be Paid Differently?
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 both sponsor and site perspectives. Edye and Darshan break down how location, site type (academic vs. independent), op...
How to Build an AI Compliance Program
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. As regulators like the FDA and FTC tighten their expectations, companies must proactively implement structured, cross-functional AI compliance programs.
Key Topics Covered:
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What the Big Beautiful Bill Means for Trial Sites
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 and site viability.
Edye raises concerns that the legislation may lead to the closure of small physician practices and rural health centers that rely heavily on government reimbursement to operate. These closures cou...
Co-Pay Mistakes Can Trigger DOJ Action
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 because they weren’t serious, but due to insufficient specifics—the upcoding charges remained. Why? The whistleblowers backed them with actual claim numbers, billing codes, and re...
NIH Grant Denials Ruled Discriminatory?
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 Darshan caution that this is just one step in a longer legal process and not a final resolution. Appeals are expected, and the ruling could be reversed or narrowed.
T...
Are Speaker programs supposed to be salesy?
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 presentation is vetted by a Medical-Legal-Regulatory (MLR) team. Despite all this oversight, violations are common—and patients can report them under FDA’s Bad Ad program.
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DTP Compliance Just Got Tricky
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 physicians. While most leads went nowhere, the court ruled this did not constitute a referral under AKS, since marketers weren’t influencing medical decisions and doctors retained full judgment.
Should You Use AI to Draft Informed Consent?
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 tool, especially for high-volume sponsors. But using it for final documents without oversight is risky.IRB Temp...
Could You Survive a Surprise Pharmacy Audit?
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 from 2019. If you’re relying on outdated policies, verbal explanations, or friendly smiles to pass inspection, you’re already behind.
Logs mu...
Self-Reporting in Clinical Trials
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 regulations and enforcement trends.
Darshan highlights the distinction between “should you report” and “is it reportable.” Not everything unethical is legally reportable, but stakeholders must assess the risks of not reporting, including potential regulatory, investor, or reputat...
$14M Fine Says This “Free” Offer Wasn’t Legal
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 highlights how well-meaning “value-add” services can turn into legal liabilities.
Key takeaways:
Value can become a liability – Helpful services may...Nonprofit Pharma Exists. Here is how it works
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 million doses annually. Civica's mission-driven approach includes transparency, cost-plus pricing with an 18–20% operating margin, and governance by health systems and philanthropic organizations to ensure adherence to its nonprofit goals.
C...
FTC Rules for Pharma Companies
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 private equity clients during the investment process by conducting due diligence, analyzing IP protection, and addressing potential FDA and marketing issues. Post-investment, the firm often acts as outside general counsel for the medical...
Whistleblowing in Clinical Trials: Is It Worth the Risk?
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 to act. However, they highlight the gray areas where judgment calls blur the lines between compliance and ethical obligations. Both caution that despite legal protections, whistleblowers often find themselves unemployable in the industry afterward.<...
The Right Way to Do Medical Affairs on LinkedIn
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 LinkedIn to connect, exchange ideas, and consume scientific content. She emphasizes that separate medical affairs handles allow companies to share timely, scientifically accurate, and balanced information, while avoiding the noise and promotional tone...
