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.
Cosmetic ingredients the FDA doesn’t want you to use
A brief discussion on the various cosmetic ingredients used by cosmetic manufacturers and the concerns FDA has recently found as a result of their own study into the process
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Why Federal Agencies Are Targeting Executives
Federal enforcement is changing. Regulators aren’t just going after companies anymore. They’re naming CEOs, CMOs, heads of clinical, quality, and operations in consent decrees and injunctions. Once your name is on that document, it follows you for years and shapes your career.
In this episode we unpack:
Why enforcement has shifted toward individual accountabilityHow repeated compliance failures trigger personal liabilityData integrity and why it matters more than everWhy clinical research and telehealth are now in regulators’ crosshairsWhat personal obligations look like inside a consent decreeWhat executives should be doing now to protect themselvesIf you...
Why the New Food Pyramid Matters to You
Everyone’s talking about the new food pyramid like it’s diet advice. I’m here to tell you it’s regulatory policy in disguise. In this episode I break down why this change matters beyond grocery aisles: school meal rules, food labeling, federal purchasing, and how the government quietly reshapes what counts as “healthy.” If you think this is just about fats and grains, think again. This affects prices, marketing claims, and what ends up on kids’ plates. I’m a food and drug lawyer focused on how policy becomes enforcement, and I’ll tell you what you need to know in str...
Ex FDA Commissioner Robert Califf on FDA Authority, Politics, and the Health Crisis No One Wants to Name
Episode Description
In this episode, Darshan Kulkarni sits down with former FDA Commissioner Robert Califf for a wide-ranging conversation on FDA authority, politics, guidance, and public trust. From the loss of Chevron deference to the role of FDA as a referee, Dr. Califf explains how regulation really works and why wealth inequality has become the most serious health issue in the United States.
Episode Summary
What does it really take to run the FDA, and how political should the agency be? Former FDA Commissioner Robert Califf reflects on his...
Buying a Med Spa? GLP-1 Compliance Can Kill the Deal
GLP-1 weight loss programs are everywhere right now, especially in the med spa space. For M&A lawyers and deal teams, that popularity comes with serious regulatory risk.
In this episode, Darshan breaks down why GLP-1 compliance has quietly become a dealbreaker in healthcare acquisitions. What used to be framed as an FDA issue is now actively being enforced by state attorneys general using consumer protection and deceptive trade practice laws.
You’ll hear how the end of the FDA shortage changed what compounding pharmacies are legally allowed to do, why “research grade” GLP-1 products are no...
New crown jewel valuing patient data
For decades, biotech M&A followed a familiar script. Patents drove value. Molecules closed deals.
That script is breaking.
In today’s precision medicine transactions, the real asset is data. Longitudinal patient records, real-world evidence, and genomic datasets are now central to valuation. But unlike traditional IP, data comes with strings attached. Privacy laws, patient consent, and transfer restrictions can quietly determine whether that data is an asset or a liability.
In this episode of KLF Deep Dive, we explore why clinical data is being treated as the new IP in bi...
Your Staff is trained, but can you prove it?
Staffing and training are not just operational issues. They are inspection risks. In this episode, we break down what sponsors and regulators actually expect when it comes to site staff training. Competent staff is not enough if training is not documented. We walk through common failure points seen during FDA inspections, including missing GCP documentation, unclear staff roles, and poor escalation processes. We also discuss how structured SOPs, training logs, and clear contracts with coordinators and sub-investigators help demonstrate a real culture of compliance. The goal is simple. When sponsors or the FDA review your site, your records should...
What Happens When a Sponsor Walks Away Early?
Early termination by a sponsor can leave a clinical research site holding the bill for prep work, fees, and staffing. In this episode, Darshan explains the contract language every site should insist on to stay protected. He covers guaranteed payment for all work performed up to the termination date, reimbursement for non-cancelable expenses like IRB fees and advertising, and why a wind-down clause is essential for chart reviews, final visits, and data queries. He also explores when minimum payments or upfront funds are realistic to request. Protecting these terms upfront keeps an unexpected sponsor exit from destabilizing your operations. I...
Cosmetic Claims the FDA Hates
Your skincare product may look like a cosmetic, but one wrong claim can legally turn it into an unapproved drug.
In this episode of KLF Deep Dive, we break down the exact words, phrases, and influencer mistakes that push cosmetic brands straight into FDA drug territory. Anti-inflammatory claims. Acne treatment language. Collagen rebuilding promises. Detox buzzwords. These are not harmless marketing fluff. They are regulatory landmines.
We explain how the FDA actually classifies products, why intent does not matter, how influencers can sink your brand, and what cosmetic companies should do right now...
Biggest Legal Mistakes in Influencer Marketing
Influencers can boost visibility fast, but they also create real regulatory exposure if they go off script. The FTC requires influencers to clearly disclose any material connection to your brand, and the wrong claim in a single post can trigger enforcement or lawsuits. In this episode, I explain how I build influencer contracts with mandatory disclosure language, claim restrictions, and takedown rights. I also describe how I design monitoring systems so brands can review influencer content before or after posting, and how I create influencer playbooks to keep everyone aligned. When done right, influencer marketing becomes a compliant and...
Your Mood, Energy, and Sleep Claims Might Be Regulated
A lot of brands start with harmless wellness promises like better mood, more energy, or improved sleep. As the business grows, though, marketing often becomes bolder, and that’s where risk creeps in. The FDA steps in when your claims imply treating or preventing a disease, which can flip your product into drug or device territory. The FTC expects every wellness claim to be truthful and supported by real evidence. In this episode, I explain how I review labels, websites, and social content, map each claim to the right regulatory bucket, and draft compliant alternatives that keep your marketing app...
Device Fail: The Legal Anatomy of a Faulty Implant Scandal
A knee implant meant to restore mobility. A surgeon secretly collecting international trips and consulting checks. A device company accused of selling a product they allegedly knew would fail. This episode breaks down the Aesculap case, the $38.5M settlement, and what it teaches us about kickbacks, forged FDA documents, and the catastrophic cost of weak compliance controls. If your team works in pharma, med-tech, or clinical research, you don’t want to miss this one.
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5 Documents the FDA Will Demand on Site — Are You Ready?
In this episode of DarshanTalks, you dive into what U.S. Food and Drug Administration (FDA) inspectors will demand when they show up on-site. You walk through the five critical documents every life-sciences or pharma company should have ready, because without them, an inspection can become a deal-breaker fast.
You stress that compliance isn’t just paperwork; it’s the backbone of long-term viability. A weak document trail, sloppy record-keeping, or missing records can lead to penalties, regulatory exposure, or even shutdowns. Tight compliance and strong documentation aren’t optional. They’re deal insurance.
The ep...
Cosmetic Marketing Mistakes That Trigger Regulators
Beauty brands hit trouble when they forget they’re dealing with two regulators, not one. The FDA controls how cosmetics are labeled and when a claim crosses into drug territory. The FTC cares about whether your marketing is truthful, especially online, and expects competent and reliable scientific evidence for every objective claim you make. Say “clinically proven” without real clinical data and both agencies may come knocking. In this quick breakdown, I explain how to align your claims so they excite consumers while staying compliant. Protect your brand, limit risk, and build trust. Call, click, or email if you need he...
Why Your Clinical Trial Contract Is Leaving Cash on the Table
Clinical research sites lose money when sponsor contracts skip the real costs of running a study. In this episode, Darshan breaks down how to protect your site by building a detailed, task-based budget instead of accepting broad lump-sum payments. He explains why every activity needs to be itemized, from screen failures and pharmacy prep to coordinator overtime and regulatory time. You’ll hear practical tips on tying costs to CPT codes, adding overhead where possible, and making sure you can bill for out-of-scope work like unexpected SAEs and follow-up. He also highlights a commonly overlooked issue: what gets paid wh...
Why Testimonials Can Get Your Brand Sued
Before-and-after photos and glowing testimonials can sell products fast, but they’re also some of the most heavily scrutinized tools in advertising. The FTC requires that any endorsement reflect typical results, and the old “results not typical” fine print no longer cuts it. In this episode, I explain how I review and edit testimonials for compliant disclosures, how I evaluate before-and-after images for accuracy, permissions, and unintentional manipulation, and how I help brands build clear internal policies to prevent drift. The goal is to keep authentic customer stories in your marketing without escalating your legal risk. Call, click, or email...
How to Get Sponsors to Pay Faster than Net 90
Can I negotiate faster payment terms so I don't run out of cash flow? Many sponsor contracts set 90 to 120 day payment timelines. This, however, cripples cash flow for smaller sites. Now you can try to negotiate net 30 or at least milestone-based payments. That means that there's a startup fee paid upon contract execution, quarterly payments regardless of enrollment pace, but the truth is you're not going to get very far with it. Enforcement is just tough. Another tool is an interest-on-late payments clause. So even if you can rarely enforce it, it does act as a way to have c...
Compliance Mistakes That Kill Pharma and Biotech Deals
Darshan Kulkarni explores why compliance isn’t just a side issue—it’s often the ultimate dealbreaker in pharma and biotech transactions.
When buyers look at acquiring a company in life sciences, they’re not just acquiring assets, patents, or promising pipelines. They’re also taking on the company’s regulatory baggage. If that baggage includes off-label promotion, billing fraud, improper trial oversight, or weak documentation, the deal could be dead on arrival.
Darshan explains how regulators—particularly the DOJ and FDA—expect compliance to be fully integrated into M&A due diligence...
Balance FDA Rules with FTC Advertising Requirements
Brands often struggle to balance FDA cosmetic rules with FTC advertising standards. The FDA oversees labeling and determines whether a product is a cosmetic, drug, or soap, while the FTC enforces truth in advertising across all marketing. Claims like “clinically proven” require solid scientific evidence, and overreaching claims can trigger scrutiny from both agencies. For growing brands—especially those investing in digital marketing—regulatory compliance is essential. Aligning marketing claims with both excitement and credibility helps companies avoid enforcement risks, build consumer trust, and strengthen partnerships.
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Key Clauses in PI Contracts to Review
Many clinical trial site leaders overlook critical risks hidden in physician employment agreements. These contracts often contain clauses that can expose sites to financial, legal, and operational danger if not carefully reviewed.
Key Risks to Watch Out For:
Compensation Structures: Incentives tied to patient enrollment can raise anti-kickback and fraud concerns. Payments should reflect fair market value for time and expertise, not results.Data Ownership: If not explicit, investigators may claim ownership of trial data, patient lists, or publication rights. Agreements should clarify that the site owns...
Compliance guru talks practical Insights on Speaker Programs
In this episode, host Darshan Kulkarni speaks with Joseph Keeney about speaker programs in the life sciences industry, exploring practical differences between small and large companies. They highlight that while fundamentals like compliance, pragmatism, and sound business principles apply across organizations, strong mitigating controls and adherence to legal and industry codes are critical.
Joseph explains the importance of engaging with various business units to understand real plans, aligning training programs with compliance needs, and avoiding pitfalls that could trigger violations of federal anti-kickback statutes. He emphasizes careful management of speakers bureau rosters, evaluating the...
Trends in Small Life Sciences Transactions
Darshan Kulkarni in conversation with Nella Bloom, for an in-depth discussion on the current state of small business transactions, private equity trends, and the challenges of advising clients in an unpredictable market.
Nella, an experienced attorney specializing in mergers and acquisitions and fractional general counsel services, explains how today’s business climate feels increasingly unstable. Rapid regulatory changes, unpredictable government responses, and evolving funding structures have made it difficult for lawyers and entrepreneurs alike to plan ahead. From shifting SBA lending rules to changing tax and formation requirements, she notes that the uncertainty affects ev...
Protect Your Site If a Sponsor Terminates Early
When sponsors terminate a clinical trial early, research sites may face financial losses for preparatory or ongoing work. To mitigate this risk, contracts should explicitly guarantee payment for all work performed up to the termination date, as well as reimbursement for non-cancellable expenses such as IRB fees, recruitment advertising, and staff training. Including a wind-down clause ensures compensation for necessary closeout activities—such as patient chart reviews, final visits, and data queries. Sites may also consider negotiating a minimum payment guarantee if termination occurs within the first 6–12 months and requesting upfront payments to offset early-stage costs. These protections help...
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.
