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.
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 If you’re relying on outdated policies, verbal explanations, or friendly smiles to pass inspection, you’re already behind.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...
Are We Paying Clinical Trial Patients Enough?
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 ConcernCompensation for trial participation is often scrutinized by IRBs due to concerns around coercion. Historically, this concern stems from extreme abuses (e.g., experiments in Holocaust camps) and evolved to include more nuanced forms, such as overpromising benefits or targeting vulnerable populations. IRBs are cautious that financial incentives don’t und...
Pharma Ads Are Getting Canceled
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 outdated playbooks, you’re in trouble—Google’s new AI can spot violations at lightning speed, often before you even see it. Ads can be blocked mid-upload, campaigns can collapse without warning, and Google now judges not just the content but your b...
Unpacking Screen Fail Payments in Research
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, without oversight, opens the door to unlimited financial exposure—and more dangerously, potential kickback violations. They emphasize the need for fair market value, capped budgets, and data-driven estimates of expected screen failure rates.
Post-Trump Antitrust Rules Are Crushing Pharma Deals
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 antitrust address, emphasized a renewed focus on strict legal enforcement. Rather than relying on expansive regulatory interpretations, the administration is doubling down on clear statutory authority. This signals a return to more traditional antitrust principles, with heightened scrutiny of M&A...
7 Must-Know Steps to transfer medical device ownership
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 programs should align with both the 2024 DOJ and OIG guidelines to demonstrate regulatory commitment. Conducting a comprehensive gap analysis helps identify compliance risks before the sale. The FDA ownership transfer registration is essential to prevent operational disruptions, along with any necessary state-level reporting. Lastly, a clear agreement outlining...
Responding to Site Findings
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 positioned to analyze what went wrong.
The site team (usually led by QA or compliance professionals) needs to:
Propose...
Is Your Medical Website Illegal?
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 communications implying off-label use can lead to violations under the Food, Drug, and Cosmetic Act, even for FDA-cleared devices.Improper Audience Targeting: Specialized medical affairs websites are intended for healthcare professionals. If content inadvertently targets patients...Price Fixing in Clinical Research
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")—a move that borders on illegal price fixing.
Darshan raised red flags, emphasizing that while site collaboration is valuable, actions like setting uniform pricing or paying for patient referrals can violate antitrust and anti-kickback laws. Edye pointed out...
DOJ Cracks Down on Pharmacy Fraud
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 200 individuals in similar cases amounting to $2.75 billion in fraud claims. Pharmacies, both large and small, are increasingly under scrutiny as enforcement agencies widen their focus.
For pharmacists, compliance officers, and legal professionals working with pharmacies, this trend serves as...
Protect Your DTP Strategy
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 safeguards, companies take on massive compliance liabilities. Telehealth prescribing raises serious questions around physician independence and anti-kickback regulations. Fulfillment introduces risks tied to product integrity, recalls, and data privacy. Even cash-based payments can trigger transparency violations an...
AI Clinical Trial Negotiators
Today, we're diving into a hot topic in clinical trials: should you use AI to negotiate your next clinical trial agreement? Darshan is joined by Elizabeth from the University of Cincinnati and Istvan Fekete from Huron Consulting, who share their experiences and thoughts on using AI for contract and budget negotiations. They discuss the potential and limits of AI, highlighting concerns over copyright, data ownership, and "black box" decision-making. While AI can streamline contract review with tools like word plugins, there's consensus that human oversight will remain crucial. AI can help create initial drafts and flag key points, b...
SOPs: How Many is Too Many?
In this discussion, Edye Edens and Darshan Kulkarni tackle one of the most common questions in clinical research: How many SOPs should a site have? While many assume a fixed number like 12, the reality is more nuanced.
From a site perspective, having extensive SOPs can feel overwhelming, but they are essential for compliance and audits. SOPs are the first thing requested during inspections by the FDA or sponsors. However, sites must strike a balance—too few SOPs indicate a lack of structure, while too many can create unnecessary complexity.
...Is DTP Pharma’s Next Big Move?
In a recent interview between Nirpal Virdee and Darshan Kulkarni, they discussed the ongoing shifts in the pharmaceutical industry, particularly the rise of Direct-to-Patient (DTP) models. The conversation explored how these changes are driven by the pressure to reduce drug and device costs, especially in light of new tariffs that could further escalate prices. Darshan emphasized the need for pharmaceutical companies to rethink their operational models, including cutting out intermediaries to bring down costs while still optimizing patient engagement.
The role of AI was also debated. While AI is seen as a potential tool...
Hackers Are Stealing Your Personal Health Data
Health records are one of the top targets for hackers. These records contain a wealth of personal information like Social Security numbers, insurance details, and medical history, making them a gold mine for cybercriminals. Hackers use this data to steal identities, open credit cards, and even file fake tax returns. The scariest part? They can create fake identities for illegal activities, such as drug purchases or money laundering.
Why does this happen? Healthcare organizations often rely on outdated technology, making them vulnerable to attacks. Hackers exploit these weaknesses, and because the stakes are high...
How a “Medical Education” Program Became a $202M Fraud
We unpack the $202 million storm surrounding Gilead’s so-called “educational” speaker programs — and why it should make every medical affairs, legal, marketing, and compliance professional sit up straight.
Here’s what happened: The DOJ alleged that Gilead turned 17,000 speaker programs into a covert marketing machine to boost HIV drug prescriptions. We’re not talking about the occasional misstep — we’re talking wine-paired steak dinners at the James Beard House, prescribers being paid over $300,000 in honoraria, and attendees showing up to the same slide deck as many as 75 times.
The DOJ didn’t just scru...
Webinar Recap: What Sponsors Must Know About Fraud
After our first-ever deep dive webinar on ‘Protecting Sponsors, Fraud & Compliance in Research,’ Darshan Kulkarni, Edye Edens, and Nirpal Virdee sat down to reflect on what turned out to be a high-impact and incredibly timely conversation.
Nirpal (the newest face on the team, leading business development) shared how exciting it was to finally launch a series we’ve been planning for months — tackling hot-button issues like regulatory scrutiny from DOJ, ORI, OIG, and the political narratives surrounding clinical research.Edye emphasized the strong audience engagement — not just around prevention of fraud but real, practical...AI-Powered Engagement is a Minefield
AI voice tech might be the next big privacy risk for pharma marketers, and lawsuits are already in motion. In this episode of Darshan Talks, we dive into the legal challenges surrounding AI-powered voice tools in healthcare marketing, especially under California’s strict privacy laws.
A federal court ruling in Ambrose v. Google suggests that recording conversations without explicit real-time consent may be illegal. This could impact pharma companies using AI voice assistants, Alexa skills, voice bots, and patient support apps. If your tech processes speech wi...
Webinar Update: Fraud Prevention Strategies Every Sponsor Needs
Event details- https://www.linkedin.com/events/protectingsponsors-fraudandcomp7318667647213002752/comments/
Registration Link- https://us02web.zoom.us/meeting/register/KhsVL6C6Tg6KKNDRHYTEKA
In this kickoff conversation, Darshan Kulkarni and Edye Edens introduce a candid new series exploring how legal and compliance professionals approach clinical research differently—but with a shared mission. The idea was born at the Save Our Sites event, where they realized they often take distinct, yet complementary, paths to solve the same problems.
Edye dr...
Are Your Promotional Claims Putting Your Company at Risk?
Guardant Health’s recent $292 million victory against Natera in a false advertising lawsuit sets a critical precedent for the biotech industry, highlighting the severe consequences of misleading claims. This case is a wake-up call for drug and device companies navigating complex FDA and FTC regulations. False advertising not only misleads stakeholders but also exposes companies to significant financial losses and regulatory scrutiny.
Compliance officers and marketers must work together to ensure promotional materials are accurate, legally sound, and fully substantiated. Your PRC team should include both regulatory experts and legal professionals to verify claims, su...
Privacy Dangers Lurking in Clinical Trial Mergers
Darshan Kulkarni and Edye Edens discuss the critical role of data privacy in clinical trial site acquisitions. While privacy concerns can seem daunting, they don’t have to be a dealbreaker if managed correctly. The key is understanding whether privacy laws like HIPAA apply, ensuring the site is already handling data compliance well, and putting safeguards in place to mitigate risks. Investors should conduct thorough due diligence to assess the site's current privacy practices before the merger or acquisition.
One major misconception is that HIPAA always applies to clinical trial data. In reality, properly an...
The FDA's Crisis Is Now Your Problem
The FDA you designed your protocol around may no longer exist. In this episode, Darshan Kulkarni breaks down why clinical researchers, regulatory attorneys, and promotional review teams need to pay attention—now.
With mass layoffs, frozen guidances, and a reorganization shaking CDER and CBER to their core, trial timelines, IRB reliance, and even legal interpretations are in flux. Marketing teams are flying blind with the FDA’s communications division gutted and post-Loper Bright challenges looming large.
Darshan outlines urgent next steps:
✔️ Rethink your submission timelines
✔️ R...
Broken FDA, Big Consequences
The FDA is facing unprecedented turmoil—staff cuts, a sweeping reorganization, and political interference are undermining its ability to safeguard public health. Former agency leaders are raising red flags, with one likening the situation to "flat earthers taking over NASA." With vaccine data access becoming politicized, stem cell oversight potentially weakening, and the user fee system in jeopardy, startups and pharma companies must treat this not as a minor policy shift but as a major compliance crisis. If you're not already reassessing your regulatory strategy, you're falling behind.
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You are now the Healthcare Provider - The Future of Health Insurance: Trends, Challenges, and Innovations
In this episode, Kate Woods and Darshan Kulkarni discussed the shift from employer-sponsored health insurance to individual responsibility, a transition accelerated by policy changes and rising healthcare costs. Traditionally, employer-provided insurance has been the backbone of the U.S. healthcare system, but evolving regulations, including the Affordable Care Act (ACA), have made individual plans more accessible. This shift has given employees greater flexibility but also placed the burden of navigating complex insurance options on them, often without sufficient guidance.
One key development in this transition is the rise of Individual Coverage Health Reimbursement Arrangements...
Essential Due Diligence Steps for Clinical Research M&A
When mergers and acquisitions intersect with clinical trials, due diligence becomes a crucial step in ensuring a successful transition. In this insightful discussion, Darshan Kulkarni and Edye Edens explore the key legal and operational considerations when acquiring or merging with clinical research entities, including sponsors, sites, and CROs.
A major focus of the conversation is understanding the risks associated with clinical trial sites. Many private equity investors are actively looking to acquire research sites, but without proper planning, these deals can present significant challenges. One of the biggest concerns is the departure of key...
Is AI Telemarketing Strategy Illegal?
Today’s episode is a wake-up call for pharma marketers launching telehealth campaigns. If you're using AI voice assistants or call automation tools in your outreach, you could be stepping into a legal minefield under California’s privacy law (CCPA & CIPA).
Your telehealth campaign reflects your brand—don’t let privacy lawsuits define it. Contact the Kulkarni Law Firm for a legal review of your telehealth tools to ensure compliance and protect your reputation.
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No Clinical Trial Waste
In this episode, Darshan Kulkarni explores an important yet often overlooked question—what happens after a clinical trial ends? While much focus is placed on clinical trials as a care option, the conversation shifts to the opportunities that exist for research-related resources post-trial.
Darshan is joined by:
Lorri Warren, Program Director of the MedSurplus Alliance at the Task Force for Global Health, which focuses on improving healthcare systems and managing medical product donations.Donna Libretti Cooke, a consultant for Kits4Life, who formerly worked at Ba...The Real Meaning of Audit-Readiness in Clinical Research
Edye Edens discusses what it truly means to be site audit ready and dispels the misconception that it requires 100% compliance. No auditor expects perfection—what matters is having strong processes in place to catch and address issues in real time, particularly those with safety or regulatory implications.
Being audit-ready means having the infrastructure to identify whether mistakes are isolated incidents or part of a larger trend requiring corrective action. Just like building credit requires a history of responsible transactions, regulatory credibility comes from demonstrating the ability to detect and resolve compliance issues effectively.
...Ordinary People Are Changing Medicine
Citizen biohacking is an empowering movement where individuals take medical innovation into their own hands, often stepping in when traditional medicine falls short. Driven by necessity, love, and a desire for survival, many have solved complex medical problems themselves, leading to groundbreaking discoveries. This trend raises important questions about safety, ethics, and the future of healthcare, with both promise and complexity.
One of the most well-known examples is Lorenzo’s Oil, where Michaela and Augusto Odone developed a treatment for their son Lorenzo, who was diagnosed with a rare and fatal genetic disorder. Their re...
Investor Influence Can Trigger FCA Violations
Mergers and Acquisitions (M&A) in the healthcare sector can be highly profitable, but they carry significant legal risks, particularly for private equity investors and board members who hold excessive influence over operations. The case of US XRL Martino Fleming vs. South Bay Mental Health Centers serves as a cautionary tale, highlighting how overstepping operational boundaries can lead to False Claims Act (FCA) violations. Investors, eager to enhance efficiency and profitability, may inadvertently trigger scrutiny by imposing aggressive performance targets or controlling daily operations, which could cross the line into operational control. In this...
Sponsor to Organization vs. Direct Investigator Agreements: Pros & Cons
Edye Edens from KLF highlights the key differences between sponsor-to-organization agreements and direct investigator agreements. Larger research organizations and academic medical centers often prefer sponsor-to-organization agreements because they provide structured negotiations around intellectual property (IP) rights, indirect costs, liability protections, and compliance oversight. These agreements also ensure that investigators have access to institutional resources and support.
On the other hand, direct investigator agreements may offer a faster turnaround, but they come with greater risks. Investigators negotiating independently might agree to terms that organizations would typically reject, potentially exposing themselves to legal and financial liabilities.<...
Clinical Trial Site M&A: What Most Get Wrong
Most clinical trial site mergers focus on patient databases, sponsor contracts, and geographic expansion. While those are important, the real risks lie elsewhere—buried in compliance issues that can derail your deal before it even closes. Imagine acquiring a site that looks great on paper, only to face FDA or DOJ scrutiny months later due to undisclosed 483s, protocol deviations, or even kickback violations. Instead of scaling operations, you're dealing with regulatory investigations and potential fraud issues.
These risks are avoidable—if you know where to look. Before merging clinical trial sites, conduct thorough due...
