DarshanTalks Podcast
By: Darshan Kulkarni
Language: en-us
Categories: Science, Life, Education, Society
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.
Episodes
Ex FDA Commissioner Robert Califf on FDA Authority, Politics, and the Health Crisis No One Wants to Name
Jan 08, 2026Episode 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...
Duration: 00:29:59Buying a Med Spa? GLP-1 Compliance Can Kill the Deal
Jan 08, 2026GLP-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...
Duration: 00:08:58New crown jewel valuing patient data
Jan 02, 2026For 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...
Duration: 00:01:10Your Staff is trained, but can you prove it?
Dec 26, 2025Staffing 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...
Duration: 00:00:46What Happens When a Sponsor Walks Away Early?
Dec 23, 2025Early 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...
Duration: 00:00:59Cosmetic Claims the FDA Hates
Dec 22, 2025Your 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...
Duration: 00:06:53Biggest Legal Mistakes in Influencer Marketing
Dec 18, 2025Influencers 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...
Duration: 00:00:54Your Mood, Energy, and Sleep Claims Might Be Regulated
Dec 11, 2025A 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...
Duration: 00:01:04Device Fail: The Legal Anatomy of a Faulty Implant Scandal
Dec 10, 2025A 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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Duration: 00:04:585 Documents the FDA Will Demand on Site — Are You Ready?
Dec 09, 2025In 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...
Duration: 00:00:56Cosmetic Marketing Mistakes That Trigger Regulators
Dec 04, 2025Beauty 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...
Duration: 00:01:08Why Your Clinical Trial Contract Is Leaving Cash on the Table
Dec 02, 2025Clinical 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...
Duration: 00:01:28Why Testimonials Can Get Your Brand Sued
Nov 29, 2025Before-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...
Duration: 00:00:52How to Get Sponsors to Pay Faster than Net 90
Nov 27, 2025Can 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...
Duration: 00:01:00Compliance Mistakes That Kill Pharma and Biotech Deals
Nov 14, 2025Darshan 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...
Duration: 00:06:29Balance FDA Rules with FTC Advertising Requirements
Nov 12, 2025Brands 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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Duration: 00:01:08Key Clauses in PI Contracts to Review
Nov 10, 2025Many 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... Duration: 00:06:14
Compliance guru talks practical Insights on Speaker Programs
Nov 07, 2025In 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...
Duration: 00:13:11Trends in Small Life Sciences Transactions
Nov 05, 2025Darshan 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...
Duration: 00:12:46Protect Your Site If a Sponsor Terminates Early
Nov 03, 2025When 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...
Duration: 00:00:59Are Pharma Chatbots Putting You at Regulatory Risk?
Nov 01, 2025Pharmaceutical 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...
Duration: 00:05:34Are Your Cosmetic Company Records Ready for FDA Audits?
Oct 30, 2025Companies 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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Duration: 00:01:08When Medical Affairs Becomes Commercial in Disguise
Oct 24, 2025Darshan 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...
Duration: 00:06:11Serious Adverse Event Reporting Under MoCRA
Oct 22, 2025Under 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...
Duration: 00:01:12Key SOPs for Clinical Trials
Oct 20, 2025Darshan 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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Duration: 00:00:51Payer Presentations Can Trigger Enforcement
Oct 18, 2025The 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...
Duration: 00:06:00Pharmacies v manufacturers
Oct 16, 2025In 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...
Duration: 00:11:56Is Clinical Research Ready for the new FDA?
Oct 13, 2025The 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....
Duration: 00:00:58Is your cosmetics company FDA-registered?
Oct 11, 2025Cosmetics 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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Duration: 00:01:06Will AI Replace Doctors in clinical research?
Oct 09, 2025Darshan 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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Duration: 00:00:51Risks in Direct-to-Patient Engagement
Oct 07, 2025Direct-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...
Duration: 00:02:49Inside 340B: Challenges, Controversies, and Opportunities
Oct 01, 2025Darshan 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...
Duration: 00:14:43IRBs in 2025: What’s Really Changing?
Sep 27, 2025In 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...
Duration: 00:05:413 Red Flags in Telemedicine Partnerships
Sep 25, 2025In 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... Duration: 00:02:49
What do PBMs do?
Sep 21, 2025In 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...
Duration: 00:12:29How AMCs Build Stronger Compliance Cultures Together
Sep 19, 2025In 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...
Duration: 00:10:49How One DME Scheme Cost Medicare $61 Million
Sep 15, 2025In 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
Sep 12, 2025The 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...
Duration: 00:03:53Top 5 Factors Determining AMC Funding
Sep 09, 2025Darshan 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...
Duration: 00:08:54New Series Drop: Exploring AMCs in Clinical Research
Sep 06, 2025Darshan 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...
Duration: 00:09:44Why Choose a Licensed Attorney Over a Consultant?
Sep 04, 2025Edye 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... Duration: 00:05:35
Marketing Problems by Hims & Hers and Lilly
Sep 02, 2025Telehealth 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...
Duration: 00:03:45Should Sponsors Share Site Feedback?
Aug 29, 2025Darshan 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...
Duration: 00:04:53AI Marketing Playbook for Drug Companies
Aug 26, 2025AI 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...
Duration: 00:03:30Should Sites Be Ready on Standby?
Aug 23, 2025Edye 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... Duration: 00:05:24
Eastern District of PA Targets Pharmacies
Aug 21, 2025The 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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Duration: 00:00:43Telehealth Done Right
Aug 18, 2025The 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...
Duration: 00:03:32DOJ and HHS Launch FCA Fraud Task Force
Aug 15, 2025In 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... Duration: 00:06:20
Should Sponsors Cover Malpractice Insurance?
Aug 13, 2025Darshan 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...
Duration: 00:04:13Instagram Post that Sparked FDA Warning Letter
Aug 11, 2025In 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...
Duration: 00:04:44Why Are So Many Doctors Getting Arrested?
Aug 09, 2025Why 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...
Duration: 00:04:26How to Run Compliant Pharma Speaker Programs
Aug 06, 2025What 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...
Duration: 00:07:54Are You Picking the Wrong KOLs?
Aug 04, 2025Darshan 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...
Duration: 00:04:28How KLF’s Client Base Evolved Over 20 Years
Aug 02, 2025Edye 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...
Duration: 00:05:13FDA Pushback on Accelerated Gene Therapy Approvals
Jul 31, 2025In 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...
Duration: 00:04:10Your DEI Program Could Trigger an FCA Case
Jul 30, 2025Darshan 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...
Duration: 00:06:04Teva’s Charity Partnership Scrutinized
Jul 28, 2025A 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...
Duration: 00:02:20Is There a “Right” Way to Calculate FMV?
Jul 25, 2025Darshan 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...
Duration: 00:12:50Can Non-Physicians Own Clinical Trial Sites?
Jul 23, 2025Can 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...
Duration: 00:03:35The KLF Story You Haven’t Heard
Jul 20, 2025In 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...
Duration: 00:08:35Why Telehealth Platforms Are Getting Sued
Jul 17, 2025We 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...
Duration: 00:06:05Should Clinical Trial Sites Be Paid Differently?
Jul 15, 2025In 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...
Duration: 00:12:21How to Build an AI Compliance Program
Jul 14, 2025In 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:
... Duration: 00:05:46
What the Big Beautiful Bill Means for Trial Sites
Jul 11, 2025Darshan 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...
Duration: 00:05:06Co-Pay Mistakes Can Trigger DOJ Action
Jul 09, 2025In 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...
Duration: 00:01:51NIH Grant Denials Ruled Discriminatory?
Jul 08, 2025Darshan 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...
Duration: 00:06:12Are Speaker programs supposed to be salesy?
Jul 04, 2025Pharmaceutical 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
Jun 28, 2025The 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?
Jun 26, 2025Darshan 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... Duration: 00:12:39
Could You Survive a Surprise Pharmacy Audit?
Jun 23, 2025Imagine 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...
Duration: 00:02:41Self-Reporting in Clinical Trials
Jun 20, 2025In 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...
Duration: 00:09:39$14M Fine Says This “Free” Offer Wasn’t Legal
Jun 18, 2025In 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... Duration: 00:03:40Nonprofit Pharma Exists. Here is how it works
Jun 16, 2025In 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...
Duration: 00:11:50FTC Rules for Pharma Companies
Jun 14, 2025In 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...
Duration: 00:12:08Whistleblowing in Clinical Trials: Is It Worth the Risk?
Jun 12, 2025In 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.<...
Duration: 00:09:28The Right Way to Do Medical Affairs on LinkedIn
Jun 09, 2025In 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...
Duration: 00:14:58Are We Paying Clinical Trial Patients Enough?
Jun 07, 2025In 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... Duration: 00:14:56
Pharma Ads Are Getting Canceled
Jun 04, 2025Google’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...
Duration: 00:04:46Unpacking Screen Fail Payments in Research
May 31, 2025In 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
May 28, 2025In 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...
Duration: 00:05:417 Must-Know Steps to transfer medical device ownership
May 24, 2025Transferring 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...
Duration: 00:02:03Responding to Site Findings
May 22, 2025At 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... Duration: 00:04:34
Is Your Medical Website Illegal?
May 20, 2025Medical 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... Duration: 00:03:32Price Fixing in Clinical Research
May 17, 2025At 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...
Duration: 00:04:03DOJ Cracks Down on Pharmacy Fraud
May 15, 2025The 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...
Duration: 00:02:09Protect Your DTP Strategy
May 13, 2025Pharma 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...
Duration: 00:03:12AI Clinical Trial Negotiators
May 10, 2025Today, 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...
Duration: 00:13:18SOPs: How Many is Too Many?
May 09, 2025In 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.
... Duration: 00:07:27Is DTP Pharma’s Next Big Move?
May 07, 2025In 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...
Duration: 00:13:04Hackers Are Stealing Your Personal Health Data
May 05, 2025Health 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...
Duration: 00:01:29How a “Medical Education” Program Became a $202M Fraud
May 03, 2025We 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...
Duration: 00:03:01Webinar Recap: What Sponsors Must Know About Fraud
May 01, 2025After 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... Duration: 00:04:06AI-Powered Engagement is a Minefield
Apr 29, 2025AI 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...
Duration: 00:02:48Webinar Update: Fraud Prevention Strategies Every Sponsor Needs
Apr 24, 2025Event 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...
Duration: 00:07:14Are Your Promotional Claims Putting Your Company at Risk?
Apr 23, 2025Guardant 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...
Duration: 00:01:38Privacy Dangers Lurking in Clinical Trial Mergers
Apr 21, 2025Darshan 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...
Duration: 00:05:45The FDA's Crisis Is Now Your Problem
Apr 18, 2025The 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
Apr 16, 2025The 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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...
Duration: 00:00:35You are now the Healthcare Provider - The Future of Health Insurance: Trends, Challenges, and Innovations
Apr 14, 2025In 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...
Duration: 00:14:52Essential Due Diligence Steps for Clinical Research M&A
Apr 12, 2025When 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...
Duration: 00:03:45