Explorez tous les épisodes du podcast DarshanTalks Podcast

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 were simply transactional processors of claims, but over time, they became key players in controlling medication costs, developing formularies, and creating step therapy protocols to ensure appropriate prescribing.

The discussion highlights how PBMs evolved in response to pharmaceutical influence on prescribers, which sometimes led to inappropriate drug use and rising healthcare costs. While PBMs help manage this, their practices—such as retaining rebates, fees, or reclassifying discounts—can sometimes increase costs for employers or patients. Siepka also underscores the influence of direct-to-consumer advertising, which further pressures providers and patients in drug selection.

Ultimately, PBMs serve as intermediaries trying to balance patient care, cost management, and insurer obligations, but their opaque financial practices make transparency critical.

For more information, reach out to us on www.kulkarnilawfirm.com 

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 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 the Compliance Alliance, a statewide network that brings together universities to openly share policies, training opportunities, and solutions to emerging challenges.

Unlike industry, where competitive pressures and proprietary concerns often limit collaboration, academia thrives on an environment of trust and knowledge-sharing. Cortni highlights how colleagues across institutions freely exchange policies, training materials, and even failures—acknowledging when a particular initiative did not succeed so others can learn and avoid the same mistakes. This willingness to collaborate builds what she and Edye describe as an “ethical ecosystem,” where compliance professionals collectively raise standards, foster mentorship, and support the broader research community.

The conversation also touches on the unique advantages of the academic setting:

• The ability to crowdsource ideas across institutions.
  
  
• The openness to borrow and adapt policies while giving credit.
  
  
• The culture of mentorship, with senior professionals guiding others through publishing, policy development, and training design.
  
  
• The freedom for compliance professionals to share broadly without being bound by the “publish or perish” pressures faced by faculty researchers.
  
  

Through real-world examples, Cortni illustrates how this cooperative approach not only strengthens institutional compliance but also creates aspirational programs that other universities look to model. The episode closes with the reminder that while every institution’s culture and resources differ, the regulatory floor is the same for all. How each university builds upon that foundation—through trust, openness, and collaboration—determines whether its program becomes one that others want to follow.

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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.
  
  
• False Documentation: Physicians and other medical providers were incentivized to generate fraudulent prescriptions and medical necessity documentation, creating a paper trail that made the claims appear legitimate.
  
  
• Excessive Billing: Using this structure, the companies submitted tens of millions in false claims to Medicare for equipment patients didn’t need—or never even received.
  
  

The Department of Justice and HHS-OIG highlighted this case as part of their ongoing crackdown on healthcare fraud, waste, and abuse, emphasizing the importance of transparency, compliance, and strong internal controls.

Compliance Takeaways:

1. Ownership transparency matters. Hidden or straw ownership arrangements are a red flag that regulators actively investigate.
   
   
2. Kickback-free operations are critical. Even “creative marketing arrangements” can be viewed as inducements if tied to patient referrals
   
   
3. Medical necessity must be genuine. Documentation is not just paperwork—it’s evidence, and falsification leads directly to liability.
   
   
4. Internal oversight saves businesses. Routine compliance audits, robust training, and third-party reviews can prevent practices from drifting into legally risky territory.
   
   

The Roussonicolos case is a cautionary tale: shortcuts and “workarounds” to grow revenue may look profitable in the short term, but in regulated industries like healthcare, they often end in criminal convictions, reputational collapse, and financial ruin.

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The FDA has recently stepped up its enforcement of pharmaceutical advertising rules, issuing 100 cease-and-desist notices and thousands of letters. These notices were largely non-personalized and intended as general guidance, emphasizing that drug advertisements must not create misleading impressions. While such enforcement has always been possible, this renewed effort signals increased regulatory attention, particularly on direct-to-consumer marketing.

Historically, FDA enforcement letters have trended downward, partly due to stronger First Amendment protections for off-label promotion. The Trump administration highlighted this issue through a presidential memorandum calling for a step-up in enforcement, though some observers see this as more of a political statement than a substantive change in authority. Nonetheless, it has drawn attention to ongoing concerns about the proliferation of drug ads and compliance with existing rules.

Future oversight may extend beyond drug manufacturers to pharmacies, online platforms, and social media influencers. Both Congress and the FDA have expressed concern about influencer-driven advertising, and questions remain about whether celebrities with significant social media followings fall under these rules. Coordination with the FTC may also be needed, as the agency regulates certain advertising claims, especially in digital spaces.

Another area of focus is closing loopholes that allow companies to refer patients to websites for side-effect information. This is likely to shift more promotional activity online, reducing costly TV advertising while keeping companies compliant. Overall, the renewed enforcement effort reflects growing scrutiny of pharmaceutical marketing, though the practical impact will depend on how agencies implement and coordinate these policies.

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Darshan Kulkarni and Edye Edens launch an exciting new episode, focusing on the unique challenges academic medical centers (AMCs) face in securing funding in an ever-changing political and regulatory environment. Unlike independent or commercial sites, AMCs operate at a different scale, often managing millions of dollars in government-funded research while navigating complex administrative structures, compliance layers, and internal politics. Edye, drawing from her 10 years inside a major AMC, shares firsthand insights into the heightened sensitivity surrounding controversial research topics, the impact of presidential and state-level funding shifts, and the pressures of maintaining compliance and operational efficiency under intense scrutiny.

The episode explores the top five factors that can determine funding success for AMCs:

1. Research topics – Certain areas may be restricted or politically sensitive.
   
   
2. DEI stances and organizational culture – Internal positions can influence perceptions and funding opportunities.
   
   
3. Key opinion leaders – Their political positions and reputations can affect institutional funding.
   
   
4. State government relationships – AMCs’ alignment with state priorities can be critical for state-funded research.
   
   
5. Regulatory efficiency – Streamlining IRB, HRPP, and other compliance processes can create operational advantages.
   
   

Darshan and Edye emphasize that understanding these factors directly from AMC administrators is invaluable. By listening to those navigating funding, compliance, and research operations in real time, AMCs and sponsors alike can better position themselves to maximize resources, maintain compliance, and continue driving innovation and patient impact.

Future episodes will expand on additional considerations, featuring industry experts and administrators sharing their perspectives and practical strategies. The series aims to provide actionable insights for AMCs, sponsors, and CROs who want to understand the realities of high-volume, high-stakes academic research.

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Darshan Kulkarni and Edye Edens are kicking off a brand-new video series diving into the unique world of academic medical centers (AMCs) in clinical research.

While KLF has long worked with sponsors, CROs, and independent sites, AMCs bring their own challenges: complex operations, unique funding models, layers of compliance, and requirements like investigator-initiated trials that don’t exist elsewhere. As Edye—drawing from 10 years inside a major AMC—explains, these environments operate at a different pace and scale, and often face resource strains even as they generate critical innovation and patient impact.

Darshan highlights how AMCs are often left out of mainstream site or sponsor conversations, despite managing volumes of research that pressure-test the entire system. Their experiences can offer invaluable lessons for industry players who want to understand how research actually succeeds—or fails—at scale.

This series will explore:
 ✅ How AMC operations differ from other sites
 ✅ Why compliance, contracts, and budgeting look different in academia
 ✅ What industry can learn from high-volume academic centers
 ✅ The regulatory and funding pressures shaping AMC research today

We haven’t picked a name yet—so we’d love your input! Drop your ideas in the comments, and stay tuned as Edye leads us through this deep dive.

Questions or suggestions? Reach out anytime at www.kulkarnilawfirm.com or connect with Darshan and Edye on LinkedIn.

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Edye Edens and Darshan Kulkarni share the origin story of KLF and explain what makes working with licensed attorneys different from hiring non-legal consultants. They highlight three key advantages:

1. Privilege & Confidentiality: Legal privilege means attorneys must keep client information confidential indefinitely—offering stronger protections than standard NDAs.
   
   
2. 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.
   
   
3. Duty to Client’s Best Interests: Attorneys are legally bound to prioritize the client’s best interests, even when it conflicts with their own financial gain.
   
   

They emphasize that while consultants and contractors bring valuable skills, legal licensing carries unique obligations and analytical approaches that can be a “game changer” for clients.

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Telehealth and pharma are facing some of their biggest compliance challenges yet—and the latest enforcement actions prove regulators aren’t slowing down.

On one side, the FTC is investigating Hims & Hers, a popular telehealth company, over allegations of misleading advertising and unfair cancellation practices. This case highlights how patient-facing companies must tread carefully when making claims about access, outcomes, or subscription services. The FTC’s involvement signals that “growth hacking” in healthcare has limits—and consumer protection laws apply just as strongly in digital health as anywhere else.

On the other side, Texas has filed a lawsuit against Eli Lilly, accusing the pharma giant of using financial incentives to improperly influence providers. This shows that traditional pharma companies aren’t immune from state-level scrutiny, particularly around patient support programs and alleged inducements. It also underscores how states are stepping up enforcement even as federal agencies tighten their own oversight.

Together, these cases send a clear message: direct-to-patient (DTP) programs are not risk-free. Whether you’re a telehealth startup or a multinational pharma, you’re operating in the same regulatory ecosystem. Advertising claims, patient subscriptions, support programs, and even reimbursement structures are now under the microscope.

In this episode, Darshan breaks down the compliance red flags exposed by both cases and shares key strategies every company should adopt to reduce risk while building sustainable DTP programs. The big takeaway? Compliance isn’t a barrier to growth—it’s the only way to ensure your innovations survive regulatory scrutiny and protect patient trust.

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Darshan Kulkarni and Edye Edens examine whether sponsors should provide feedback to clinical trial sites on why they were selected—or not—for a study. While it is technically possible for sponsors to share this information, they caution that doing so carries significant risks. These include liability concerns, potential miscommunication, and the practical challenge of managing feedback when dozens of sites may be competing for the same study.

Darshan and Edye note that while most trials—such as common therapeutic areas like hypertension, diabetes, or general oncology—offer little incentive for sponsors to provide detailed feedback, there are exceptions. Trials in rare diseases or highly specialized therapeutic areas often involve fewer qualified sites, making strong relationships and clear communication more strategically valuable. In these cases, feedback can help sites understand expectations, improve their performance, and strengthen their ongoing relationship with the sponsor.

Ultimately, both emphasize that the decision to provide site-specific feedback must balance potential benefits with practical realities and legal risks. For the majority of trials, the challenges and liability concerns outweigh the advantages, but in carefully chosen scenarios, structured and thoughtful feedback can support site development and long-term collaboration.

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AI is no longer a distant concept in pharma marketing—it’s here, transforming campaign design, review, and distribution. CEOs and CMOs face a critical question: Can I safely integrate AI into my marketing toolkit?

AI offers speed, cost savings, precise targeting, and scalable personalization. Yet, it introduces significant risks, including data ownership, opaque algorithms, hallucinated content, and potential FDA violations. Accountability for AI-generated content remains a key concern—vendors, marketing teams, or executives may all be at risk.

Some companies are proactive: implementing bias audits, ethical guardrails, contractual protections, and validation processes. Others, lacking governance, risk regulatory scrutiny. While AI can streamline PRC review, maintain brand consistency, and flag compliance risks, leaders cannot rely on technology to “figure it out later.”

The smart strategy: treat AI as a high-value, high-risk partner. Establish clear policies, define IP and ownership rights, ensure transparency, and embed accountability throughout marketing. Success in life sciences promotion will go to those who embrace AI strategically and responsibly, not those who avoid it.

The Kulkarni Law Firm helps life sciences companies build AI-ready, regulator-friendly marketing strategies that stay ahead of the competition.

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Edye Edens and Darshan Kulkarni from KLF discuss the pros and cons for clinical trial sites considering becoming backup sites. Key points include:

• Sponsor Perspective: Signing up as a backup site can give first access to trials and increase the likelihood of being selected, especially since not all primary sites meet recruitment targets. Sponsors may expect some commitment, including potential startup or maintenance costs while waiting.
  
  
• Site Perspective: Some sites may worry about being seen as “second choice,” but having the capability to quickly operationalize a trial is a valuable skill. Sites can leverage backup status to position themselves as highly reliable and adaptable, potentially creating a niche opportunity.
  
  
• Fair Market Value Considerations: Sites keeping resources on hold may justify higher compensation than standard rates due to the cost of readiness. Sponsors might negotiate a middle ground to retain qualified, dependable sites.
  
  
• Best Fit for Backup Sites: Nimble, resourceful sites (often newer or smaller) benefit most. Large academic institutions may not be suited due to planning and resource constraints. Geographic or therapeutic focus can also influence suitability.
  
  

Backup site models can be a win-win when structured properly, balancing site readiness, compensation, and sponsor needs. Sites and sponsors should carefully define terms, expectations, and fair market value for standby arrangements.

Edye and Darshan encourage listeners to share experiences or questions via email or their website.

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The Eastern District of Pennsylvania has ramped up False Claims Act enforcement against pharmacies, with cases ranging from multi-million dollar settlements to outright bans on dispensing controlled substances. Coupled with the DOJ-HHS False Claims Act Working Group and a record-breaking national healthcare fraud takedown, the message is clear: enforcement is accelerating. Pharmacy owners must strengthen compliance programs, maintain accurate inventory records, and conduct early audits—before regulators come knocking.

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The Office of Inspector General (OIG) recently issued an advisory opinion approving a telehealth business model where a management company leases clinicians and provides backend services—like scheduling, billing, and digital marketing—to a separate physician practice. While this setup might raise anti-kickback concerns, OIG says it’s compliant under the personal services and management contracts safe harbor.

This matters for pharma, digital therapeutics, and connected device companies increasingly partnering with telehealth platforms. The opinion clarifies that digital marketing services promoting physician practices can be paid for—if structured correctly. Key compliance factors include fair market value, written agreements, and fixed fees not tied to patient volume.

But beware: this opinion doesn’t bind the DOJ, doesn’t address state law or Stark, and hinges on a narrow fact pattern. If your telehealth strategy involves clinician leasing or third-party reimbursement, now’s the time to review your management services agreement.

Bottom line: this is both a roadmap and a red flag. Get the structure right—or risk regulatory trouble.

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In Fiscal Year 2024, whistleblower cases reached an all-time high of 979, signaling increased scrutiny of healthcare fraud. Just days after announcing a massive $14.6 billion healthcare fraud takedown involving 324 defendants, the Department of Justice (DOJ) and Department of Health and Human Services (HHS) launched a False Claims Act (FCA) Working Group on July 2, 2025.

This cross-agency task force is laser-focused on tightening enforcement and closing regulatory loopholes across the life sciences sector. Key targets include:

• Clinical Trials: Fraud related to consent forms, fabricated data, improper enrollment, and documentation mismanagement.
  
  
• Promotional Activities: Off-label claims, misleading speaker content, disguised kickbacks, and FTC violations.
  
  
• Pharmacy Operations: Compounding without clinical rationale, patient steering, and questionable reimbursement schemes.
  
  
• Corporate Transactions: M&A due diligence gaps that allow FCA risks to carry into deals.
  
  

Everyone from clinical research site owners and pharmacy operators to advertising managers and corporate lawyers is in the spotlight. The DOJ and HHS are encouraging voluntary self-disclosure of compliance issues, offering potential penalty mitigation—but only if disclosures are thorough and proactive.

The message is clear: life sciences companies must act now to audit their operations, re-evaluate risk, and fix known gaps before enforcement comes knocking.

At the Kulkarni Law Firm, we’re helping clients navigate this heightened enforcement landscape—whether in research, promotion, or pharmacy operations.

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Darshan and Edye tackle a hot topic in clinical research budgeting:
 Should malpractice insurance be considered an overhead cost that sponsors cover?

Edye explains both sides. Sponsors often argue that malpractice is simply a cost of being a physician, unrelated to research. Sites, however, may try to include it—at least partially—as part of trial-related overhead. But even then, justifying full coverage through a single trial is difficult.

Darshan pushes back, suggesting that including malpractice in overhead feels like “nickel and diming” for what is a baseline cost of doing business. Just as sponsors aren’t expected to cover the electricity bill directly, they shouldn’t be on the hook for malpractice coverage that’s already necessary for practicing medicine.

Academic institutions may have strong systems for tracking and justifying overhead—down to the penny. But smaller sites? That’s a trickier case. One workaround sites use: requiring physicians to carry malpractice as part of an independent contractor agreement. However, this approach opens the door to new legal complexities, like the corporate practice of medicine doctrine.

Key takeaway: Malpractice insurance is already baked into clinical practice. Expecting full reimbursement from sponsors may be unrealistic—unless the site has ironclad documentation and a clear percentage justification.

Still have questions? Reach out!

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In this episode, Darshan Kulkarni unpacks the May 29, 2025 FDA Warning Letter issued to Sprout Pharmaceuticals. The trigger? A promotional Instagram post from the company's CEO calling Addyi “the sex pill for women,” highlighting benefits but completely omitting the serious risks—like hypotension, syncope, alcohol interactions, and contraindications. To make matters worse, the post wasn’t submitted to the FDA via Form 2253 as required. This isn’t Sprout’s first offense; the FDA previously cited them in 2020, and repeat misbranding is now considered a public health risk.

Darshan emphasizes that for pharma marketing teams and legal departments, this is more than a one-off mistake—it's a compliance wake-up call. He outlines the FDA’s expectations for corrective action, including a written response within 15 business days and a plan to distribute truthful, non-promotional messages via the same platforms used for the original content. He also urges companies to ask themselves: Do we have a working SOP for executive social media posts? Are our review teams empowered to flag risky content before it goes live?

Beyond this case, Darshan offers a practical compliance checklist: have a formal social media review policy, use a centralized submission tracking system, train marketing teams on risk messaging, and audit past posts regularly. He warns that many companies underestimate the regulatory scrutiny on digital and user-generated content, making them vulnerable to enforcement action.

Bottom Line:
 In the FDA's eyes, social media is advertising—and it must follow all the same rules. Even casual executive posts can result in million-dollar mistakes. Darshan and the Kulkarni Law Firm stand ready to help companies strengthen their review systems, respond to enforcement, and avoid the reputational damage that comes with noncompliance.

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Why are headlines suddenly filled with stories of doctors, nurses, healthcare executives—and even accountants—being arrested for fraud? In this explosive episode of Daran Talks, we dive into what the Department of Justice is calling the largest healthcare fraud takedown in U.S. history.

In July 2025, federal authorities charged 324 individuals in a sweeping investigation involving an alleged $14.6 billion in healthcare fraud. From fake telemedicine visits to unnecessary prescriptions and kickbacks for referrals, this case isn't just about shady backroom deals. It includes major hospital systems, pharmacy chains, and telehealth platforms—raising serious questions about compliance in an increasingly digital healthcare system.

 What’s driving the crackdown?

• Big money: With trillions flowing through U.S. healthcare, temptation is everywhere—even for licensed professionals.
  
  
  
• Digital trails: Tech has made fraud easier to commit—but also easier to trace.
  
  
  
• Whistleblowers: Protected and financially rewarded under the False Claims Act, insiders are stepping up and speaking out.
  
  
  
• New enforcement priorities: The DOJ has launched a new False Claims Act Working Group targeting clinical trials, marketing, pharmacy practices, and telehealth.
  
  

But not all of this is malicious. Healthcare law is complex, billing codes are confusing, and honest providers can unintentionally cross legal lines. In this episode, we unpack the gray areas, outline the red flags, and offer practical takeaways for patients, providers, and policymakers alike.

Listen to this episode on Spotify, Apple Podcasts, YouTube, or wherever you tune in.
Got questions or thoughts? Share this episode, drop a comment, or reach out—we want to hear from you.

Whether you're a clinician, compliance officer, or just trying to protect your health (or your license), this is one episode you don't want to miss.

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What really happens behind the scenes of pharmaceutical speaker programs—and why should smaller pharma companies care? In this episode of DarshanTalks, Darshan Kulkarni unpacks one of the most misunderstood but highly scrutinized parts of pharma marketing: speaker programs.

These programs typically come in two forms—promotional (to raise product awareness and encourage prescribing) and educational (such as accredited CME events). While both are legal, they must be executed with extreme care. Regulatory bodies like the OIG and FDA have repeatedly called these programs “inherently suspect,” especially when the lines between education and promotion blur.

Darshan breaks down the key compliance principles you can’t afford to ignore:

• Speaker selection must be based on expertise, not just high prescribing volume.
  
  
• Agendas and content need clear educational goals—with full disclosure of both benefits and risks.
  
  
• Venues, budgets, and honoraria must remain modest and documented. Lavish dinners or exclusive retreats are red flags.
  
  
• Everything—from slides to invitations—must pass through Medical, Legal, and Regulatory (MLR) review.
  
  

Darshan emphasizes that many small and midsize companies assume these rules are just for the big players—but that’s a dangerous misconception. Regulators are cracking down across the board, especially when they see repeat patterns like promotional tone, lack of balance, or inadequate documentation.

He also highlights the importance of having SOPs for virtual events, especially as hybrid formats become more common. Virtual doesn’t mean informal: you still need clear learning objectives, interactivity, and records of attendance.

Documentation is everything. From signed speaker contracts to attendee surveys, your team should be able to demonstrate educational value if regulators come knocking.

Finally, Darshan urges companies to invest in periodic audits and cross-functional training so that compliance isn't an afterthought. If the goal is truly to educate, then every part of the program—from venue to content—should reflect that.

 Speaker programs can be valuable educational tools—but only if they’re planned, executed, and reviewed properly.

Whether you're building your first program or revisiting old practices, this episode provides practical guidance to avoid legal pitfalls while supporting ethical HCP engagement.

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Darshan Kulkarni and Edye Edens tackle the complexities of identifying and working with Key Opinion Leaders (KOLs) in clinical research. While KOLs can bring valuable expertise to a therapeutic area, simply labeling someone as a KOL—especially when they self-identify—can raise significant compliance concerns.

They unpacks two major red flags:

1. High Prescribers – Is the KOL being compensated for research or for prescribing power?
   
   
2. Influencer Effect – Are they being used to sway other physicians’ prescribing behavior?
   
   

They also highlight issues with KOL selection based on outdated reputation or academic status rather than real-time operational capacity. Choosing the wrong KOL—one who can’t meet documentation or compliance standards—can derail your site’s performance.

Key takeaway:
 Don't focus on titles—focus on capability, compliance, and fit. Avoid the label "KOL" and instead qualify experts based on their patient databases, research experience, and operational readiness.

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Edye Edens interviews Darshan Kulkarni about the evolution of the Kulkarni Law Firm (KLF). Darshan reflects on how he originally envisioned working with large pharmaceutical and device companies, but over the past 15–20 years, the firm has expanded to support not only pharma, but also law firms, consulting companies, and research sites.

They discuss how the clinical research landscape has shifted—from a focus on academic institutions and big players to a broader ecosystem that includes independent and commercial sites. 

Importantly, Darshan shares how compliance, once an afterthought in the industry, has become central to legal and operational strategy. He recounts early pushback from stakeholders who dismissed compliance, and contrasts that with today’s environment, where regulatory awareness is essential and expected.

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In this episode, Edye Edens dives into the FDA’s evolving scrutiny of accelerated approvals in gene therapy and rare diseases. Using the example of Sarepta’s muscular dystrophy treatment, she explains how postmarket safety issues and incomplete confirmatory trials can put previously celebrated approvals under renewed FDA evaluation.

Edye breaks down three common pitfalls sponsors face:

1. Lagging confirmatory trials
   
   
2. Outdated safety monitoring plans
   
   
3. Poor communication across teams and with FDA
   
   

She offers practical guidance to avoid regulatory setbacks:

• Build flexible governance frameworks
  
  
• Stay proactive with FDA engagement
  
  
• Plan for legal and regulatory risks in confirmatory trials
  
  
• Prepare for public, regulatory, and payer scrutiny post-approval

Accelerated approval is a major milestone—but it’s not the end. It's the beginning of the next regulatory chapter. Tune in to learn how to manage post-approval responsibilities and secure long-term success for your therapy.

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Darshan Kulkarni breaks down the Department of Justice’s new Civil Rights Fraud Initiative, launched on May 19, 2025, and why it should be on the radar of every pharmaceutical and medical device company. Under this initiative, the DOJ plans to use the False Claims Act (FCA) to pursue organizations that knowingly violate civil rights laws while receiving federal funds—including R&D grants, Medicare/Medicaid payments, or other government contracts.

The discussion highlights how DEI programs, supplier diversity efforts, and patient outreach initiatives—though often well-intentioned—can raise legal risks if they assign benefits or burdens based on protected traits like race or gender. Companies certifying compliance with civil rights obligations must ensure their practices truly align with federal requirements, or they risk triggering FCA liability. Darshan outlines concrete steps to update compliance programs: conducting audits, vetting DEI policies, documenting legal justifications, training internal teams, strengthening reporting systems, and preparing a response plan.

This episode is essential listening for in-house counsel, compliance officers, and executives navigating DEI and ESG obligations in a tightening regulatory landscape.

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A recent $425 million settlement involving Teva Pharmaceuticals highlights the legal and ethical risks charities face when partnering with pharmaceutical companies. Teva was accused of using a charity to cover patient co-pays, a tactic intended to boost drug sales, leading to serious legal consequences. While pharma funding can provide essential resources for charities, it also raises concerns about indirect kickbacks and regulatory scrutiny.

Charities must rethink their engagement strategies, ensuring transparency and compliance to avoid financial penalties and reputational harm. Conducting due diligence, seeking legal guidance, and structuring agreements carefully are essential steps to mitigate risks. Teva’s case serves as a warning—charities must be proactive in safeguarding their partnerships to maintain both their mission and legal standing.

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Darshan Kulkarni and Edye Edens take a deep dive into one of clinical research’s most persistent questions: how is fair market value (FMV) actually determined for clinical trial sites—and who gets to decide?

Building on the previous discussion about whether all sites should be paid the same, this episode unpacks the complexity behind FMV calculations. Darshan shares an anecdote involving a DOJ official questioning the credibility of FMV data derived from industry benchmarks, asking: “How do we know they’re not all overpaying?” That central question becomes the backdrop for a broader conversation about the opacity of FMV methodology.

Edye and Darshan explore the role of commercial pricing vs. Medicare/Medicaid benchmarks, the impact of patient compensation, and the often-overlooked categories of research-related costs like recruitment, reminders, and outreach. They suggest that standard FMV tools don’t always capture the true operational costs sites face—and that research-related services are fundamentally different from standard clinical care.

The conversation turns to the issue of transparency, revealing how internal silos at large pharmaceutical companies often prevent project managers or CROs from understanding, let alone justifying, the FMV numbers they're using in site negotiations. Meanwhile, sites—especially smaller or independent ones—have fewer layers and greater internal access to budget decisions, leaving them at a disadvantage when sponsors can't (or won’t) explain the rationale behind their numbers.

Ultimately, the episode questions whether a more transparent and stratified approach to FMV could lead to better negotiations, more equitable funding, and improved patient access. The hosts challenge the industry to consider how current power dynamics—and the lack of communication—may be shaping not just contracts, but clinical trial accessibility itself.

The episode closes by teasing a future conversation: Does the sponsor-site power imbalance impact patient care outcomes? Stay tuned.

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Can non-physicians own independent clinical trial sites? The answer isn’t as simple as it seems. In most states, including Texas, engaging in clinical research is considered the practice of medicine, which means that research sites must adhere to the same rules that apply to medical practices. This includes the corporate practice of medicine doctrine, which restricts ownership and control of medical practices to licensed physicians. As a result, non-physicians generally cannot own or manage research sites that involve clinical procedures requiring medical judgment, diagnosis, or treatment.

A common misconception is that clinical trials are separate from the practice of medicine, but the reality is that many of these trials do involve medical procedures that require compliance with state medical laws. For instance, when your principal investigator (PI) signs a Form 1572, they’re agreeing to comply with medical standards—this reinforces the idea that clinical research is governed by the same rules as medical practice.

Many research sites fail to audit their ownership structures for compliance with the corporate practice of medicine doctrine. While it’s easy to assume that “everyone else is doing it,” cutting corners can lead to disastrous consequences such as lawsuits, regulatory scrutiny, or even unwound deals. That’s why it’s important for sponsors, CROs, and investors to ensure that research sites are structured properly, that investigators are licensed in the trial state, and that sites have appropriate malpractice insurance.

At the Kulkarni Law Firm, we work with clients to ensure that their research operations are compliant, structured correctly, and protected from enforcement risks. Whether you're a sponsor, investor, or site operator, it’s critical to be proactive and audit your practices to avoid costly mistakes down the road.

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In this special episode, Senior Attorney Edye Edens sits down with Darshan Kulkarni, founder and principal of the Kulkarni Law Firm, for a personal and honest look at how the firm came to be. Darshan shares how the firm was born in the shadow of the 2008 financial crisis—at a time when job security was shaky and entrepreneurship felt more like a risk than an opportunity. What started as a leap of faith became a 15+ year journey rooted in intentionality, versatility, and a deep belief in building something better than the traditional legal mold.

Darshan recounts his unique path: working as both a pharmacist and a lawyer, taking client calls from the base of Machu Picchu, and embracing the uncertainty that comes with launching a firm from scratch. He and Edye reflect on the transitions between year one, year five, and year fifteen—how the vision has shifted, and how staying agile has helped the firm grow without losing its purpose. The conversation explores what it means to be different in a profession that often values conformity, and why both Darshan and Edye chose quality of life, real client value, and adaptability over rigid systems.

They also discuss big career moments, the influences that shaped their outlooks, and the challenges of being entrepreneurial in a space dominated by structure. Whether you’re a startup founder, a healthcare professional, or just curious about the story behind KLF, this episode offers an unfiltered glimpse into the passion and strategy behind one of the few boutique law firms dedicated to life sciences, clinical research, and regulatory innovation.

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We explore the growing wave of class action lawsuits hitting the telehealth industry—and why legal counsel, especially those advising telemedicine platforms or navigating pharma partnerships, must pay attention now.

Here’s the core issue: many ad tech stacks are leaking protected health information (PHI) through tracking pixels and cookies. These tools—common in e-commerce—are transmitting sensitive data to third parties like Meta, potentially without proper consent. That’s not a glitch; it’s a design feature—and it may violate HIPAA, the FTC Act, CCPA, and state consumer protection laws.

Key Legal Risks:

• Tracking pixels may result in unauthorized PHI disclosures.
  
  
• “Anonymized” data isn’t safe—reidentification is easier than ever.
  
  
• Partnering with pharma introduces a regulatory maze: HIPAA, FTC, FDA promotional rules, and anti-kickback statutes may all apply—and risks compound, they don’t cancel out.
  
  
• A simple ad campaign could result in kickback concerns, promotional violations, or privacy breaches.
  
  

What Legal Counsel Should Do:

1. Audit your tech stack—what tools are collecting what data, and where does it go?
   
   
2. Revisit consent practices—is the user aware of what’s being shared?
   
   
3. Separate clinical from commercial functions—these are legal firewalls.
   
   
4. Update your data sharing contracts—HIPAA, indemnification, audit rights, reuse clauses.
   
   
5. Retrain marketing teams—even one tag can trigger legal liability.
   
   

Real-World Consequences:

• OCR penalties, FTC consent decrees, and civil suits for emotional distress and privacy violations.
  
  
• Reputational damage, loss of investor confidence, and pharma partners pulling back.
  
  

At The Kulkarni Law Firm, we help telehealth platforms and FDA-regulated companies identify and mitigate these risks before they explode. From privacy reviews to marketing compliance and risk assessments, we’re here to help.

Ask yourself:

• Are you using ad pixels?
  
  
• Do your legal and marketing teams actually talk?
  
  
• Are you ready to explain, under subpoena, who got patient data—and why?
  
  

If this episode made you rethink your stack—or your strategy—share it with your team.

Get in touch with us if you have any questions. 

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In this episode of the KLF Deep Dive, Darshan Kulkarni and Edye Edens engage in a practical discussion around one of the most debated issues in clinical research: Should clinical trial sites be paid differently based on who they are, where they’re located, or what they bring to the table?

The conversation challenges the idea of flat-rate, standardized budgets for all sites and explores the concept of Fair Market Value (FMV) from both sponsor and site perspectives. Edye and Darshan break down how location, site type (academic vs. independent), operational capacity, and even patient population size can significantly affect the true cost of running a clinical trial. They also address common misconceptions—like whether having more patients always justifies higher pay—and emphasize the importance of effort tracking and cost documentation as tools for sites to advocate for reasonable compensation.

The two also examine the wide variability in how sites are funded, including differences driven by grants, institutional policies, and pass-through rules. They explore why attempts to equalize payments across the board—though well-intentioned—may backfire, creating unintended inequities that hurt both high-performing sites and trial timelines.

Darshan draws a parallel to J. Paul Getty’s famous quote, “Just a little bit more,” noting that many sites, regardless of how much they’re paid, still want more—while sponsors often feel they're already paying generously. This leads to a larger issue: the lack of transparency and shared understanding around how FMV is calculated. Sites are often expected to justify every line item with data, while sponsors rarely share the assumptions and benchmarks they use in return.

This episode explores key questions like:

• What does fair really look like in site budgeting?
  
  
• Should sponsors be more transparent about their FMV calculations?
  
  
• How do we balance standardization with the real-world variability in site operations?
  
  

The discussion sets the stage for a follow-up episode exploring whether sponsors should disclose their FMV methodologies—and how that could impact trust and negotiation dynamics across the clinical trial ecosystem.

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In this episode of KLF Deep Dive, Darshan Kulkarni explores the growing urgency for in-house counsel to develop AI compliance programs as artificial intelligence becomes embedded in drug discovery, clinical decision-making, patient engagement, and beyond.

Darshan emphasizes that AI can create significant legal risk—even without breaking the law—if companies fail to address issues of transparency, validation, privacy, and governance. As regulators like the FDA and FTC tighten their expectations, companies must proactively implement structured, cross-functional AI compliance programs.

Key Topics Covered:

• AI System Mapping
   Start by identifying all AI systems—internally developed or third-party. Understand who owns them, what data they use, and how they function. Create a living inventory that evolves with your organization.
• Validation & Explainability
   Ensure that your models are transparent, repeatable, and auditable. Document how decisions are made and build mechanisms to detect deviations. Explainability is no longer optional—regulators and litigators expect it.
• Privacy & Governance
   Align your AI systems with HIPAA, GDPR, and state privacy laws. Update privacy notices to disclose AI use and profiling. Legal and privacy teams must collaborate closely with AI developers.
• Monitoring & Decommissioning
   All systems fail or become outdated. Put in place processes to log errors, recalibrate models, and decommission AI tools without disrupting patient care.
• Contracting & Vendor Management
   Negotiate contracts that clearly define data rights, IP ownership, use limitations, and audit rights. Tie these terms back to your insurance coverage and risk allocation.
• Risk Assessment
   Use risk registers to evaluate AI systems for potential misuse, bias, or patient harm. Prioritize mitigation efforts and build policies based on real-world use, not theoretical frameworks.
•  Culture & Training
   AI compliance isn’t a document—it’s a system. Cross-functional teams (legal, medical, IT, marketing) must be trained regularly. Appoint internal champions to maintain risk maps and trigger policy updates.

Conclusion:

If your organization doesn’t know who governs each AI system—or if your contracts don’t cover AI-specific risks—you’re already behind. Now is the time to build an adaptive, defensible AI compliance program that scales with your innovation.

Kulkarni Law Firm helps pharma and health tech companies translate AI risk into operational clarity. Subscribe to KLF Deep Dive for more weekly insights at the intersection of legal risk and life science innovation.

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Darshan Kulkarni and Edye Edens examine the far-reaching implications of the newly passed “Big Beautiful Bill”—a sweeping piece of legislation tied to the Trump administration’s political agenda. While the bill itself does not directly reference clinical research, Darshan and Edye highlight how its provisions—particularly the reduction in Medicare and Medicaid funding—could have serious downstream effects on clinical trial access and site viability.

Edye raises concerns that the legislation may lead to the closure of small physician practices and rural health centers that rely heavily on government reimbursement to operate. These closures could reduce the number of viable clinical trial sites and limit opportunities for underserved populations to participate in research. Additionally, the loss of Medicare coverage for patients may hinder routine care billing within trials, further discouraging sites from participation—especially smaller ones already burdened with administrative complexity and financial strain.

Darshan adds that while academic research institutions often navigate reimbursement issues with dedicated billing teams, many private sites, particularly those with low trial volume, rely entirely on sponsors to cover costs and avoid direct reimbursement processes. He also raises the possibility that trial sites could inadvertently become the de facto providers of clinical care in underserved areas—especially if other care options disappear due to budget cuts.

The conversation evolves into a broader discussion on how health system strain may lead to increased use of telemedicine, as well as the growing reliance on nurse practitioners (NPs) and physician assistants (PAs) to fill care gaps. However, legal limitations—such as whether a PA can serve as a Principal Investigator (PI) if they are not legally allowed to make independent medical judgments—could complicate this trend. The episode closes with a teaser for a future discussion on that very question.

Viewers are encouraged to consider not just the immediate financial and political implications of the bill, but also how changes in access, coverage, and staffing may reshape the clinical research ecosystem in the years ahead.

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In Alvarez v. Lincare, the Eleventh Circuit highlighted a growing risk for pharma marketers and legal teams running Direct-to-Patient (DTP) campaigns. Lincare and Optigen were accused of defrauding the government by:

• Routinely waiving co-pays without documenting financial hardship,
  
  
• Shipping unrequested supplies,
  
  
• Allegedly paying kickbacks to boost business.
  
  

While most claims were dismissed—not because they weren’t serious, but due to insufficient specifics—the upcoding charges remained. Why? The whistleblowers backed them with actual claim numbers, billing codes, and reimbursement data. That detail made the difference.

If your DTP program involves auto-shipping kits, vague copay waivers, or incentive-based referrals, you could be next. This case shows the DOJ and whistleblowers prioritize programs lacking clear, documented compliance.

Bottom line: Innovation ≠ immunity. Marketing tactics must be clinically justified, legally defensible, and clearly documented.

Need help reviewing your DTP strategy or tightening up compliance documentation?
The Kulkarni Law Firm helps pharma teams bridge innovation and regulation—before enforcement knocks.

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Darshan Kulkarni and Edye Edens break down a recent federal court ruling that challenges the NIH’s decision to halt grant funding for projects focused on LGBTQ+ populations and DEI-related research. The judge ruled that cutting off funding solely on a discriminatory basis—such as the subject matter being DEI or LGBTQ+ related—may itself be unconstitutional. While this has sparked optimism among affected researchers, Edye and Darshan caution that this is just one step in a longer legal process and not a final resolution. Appeals are expected, and the ruling could be reversed or narrowed.

The episode explores broader implications for clinical research and federal grant recipients. They stress that this case is about discriminatory decision-making, not a reversal of all NIH funding cuts. They advise institutions and research sites to remain cautious—don’t make financial or operational decisions based on the assumption that funding will be restored.

Ultimately, this episode highlights a potential shift in how courts may view the intersection of politics, discrimination, and scientific research funding. And it sets the stage for their next discussion on the broader implications of the “Big Beautiful Bill” that’s reshaping the federal research landscape.

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Pharmaceutical speaker programs come in two forms: one aimed at promoting a product, and another focused purely on education. Both must be compliant, but many companies blur the lines—leading to billion-dollar fines. Government bodies like the OIG consider these programs “inherently suspect” unless strict criteria are met.

To stay compliant, speakers must have relevant expertise (not just high prescription rates), and every presentation is vetted by a Medical-Legal-Regulatory (MLR) team. Despite all this oversight, violations are common—and patients can report them under FDA’s Bad Ad program.

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The Seventh Circuit just issued a pivotal decision in U.S. v. Sorenson, reshaping how pharmaceutical and medical device companies should think about direct-to-patient (DTP) advertising and Anti-Kickback Statute (AKS) compliance.

In this case, Sorenson’s company paid marketers to generate patient interest in orthopedic braces reimbursed by Medicare. These marketers gathered patient details and sent unsigned prescriptions to physicians. While most leads went nowhere, the court ruled this did not constitute a referral under AKS, since marketers weren’t influencing medical decisions and doctors retained full judgment.

The takeaway? The court is drawing a line between generating patient interest and influencing prescriber behavior. For pharma marketers, this clarifies that driving patient awareness without steering doctors may reduce AKS risk—at least in the Seventh Circuit.

If your DTP campaigns involve disease awareness, educational tools, or lead gen without prescriber targeting, you're likely on safer ground. But if those leads are used to nudge physicians’ decisions, compliance risks still loom.

Bottom line: Intent and influence are everything. Want help navigating this evolving space? Contact the Kulkarni Law Firm for support with risk-adjusted marketing agreements and compliance reviews.

Subscribe to DarshanTalks for more insights on legal and compliance updates in life sciences.

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Darshan Kulkarni and Edye Edens discuss the potential and pitfalls of using AI—like ChatGPT—to draft informed consent documents in clinical research. With both legal and regulatory expertise, they explore how AI could save time, whether it fits institutional IRB requirements, and the real-world value (or lack thereof) for different types of organizations.

Key Takeaways:

• Drafting vs. Final Use: AI can be useful as a first-draft tool, especially for high-volume sponsors. But using it for final documents without oversight is risky.
  
  
• IRB Templates Matter: Many IRBs (especially academic or VA-affiliated) require strict templates—limiting AI's value unless those are integrated upfront.
  
  
• Regulatory Landscape: AI-drafted consents must meet not just FDA standards, but also OHRP requirements. Compliance and clarity are non-negotiable.
  
  
• Customization Is Key: Most current AI tools are just wrappers over ChatGPT. Real ROI comes from domain-specific models trained for clinical research.
  
  
• Data & IP Risks: Feeding protocols into AI raises confidentiality concerns. Plus, who owns the output remains unclear due to copyright issues with training data.
  
  
• Why ROI Falls Short: Companies often reassign internal staff instead of building bespoke solutions. Without a clear use case or strategic planning, results disappoint.

AI shouldn’t replace people—it should support them. Darshan and Edye agree: if you're using AI to generate a first draft of informed consent documents, it could help streamline high-volume workflows. But expecting it to generate a compliant final version is unrealistic. Most current tools feel more like flashy "wrappers" around existing models and often lack a strong ROI. And let’s not forget the hidden risks—like IP concerns and exposing proprietary protocols.

Bottom line? AI has potential, but without strategic investment and oversight, it’s just another overhyped shortcut. Use it wisely, or not at all.

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Imagine you're filling a script when a State Board of Pharmacy inspector walks in—no warning, just a clipboard and serious consequences. Most community pharmacists assume, "That won’t happen to me," but audits are no longer rare—they're the norm.

Controlled substances are under intense scrutiny. Inspectors now expect airtight records, ongoing (not one-time) training, and SOPs that reflect current laws—not ones from 2019. If you’re relying on outdated policies, verbal explanations, or friendly smiles to pass inspection, you’re already behind.

Logs must match dispensing. Staff must follow documented protocols. Lock zones must meet state requirements. Every mismatch? A red flag.

At the Kulkarni Law Firm, we help pharmacies:

• Conduct proactive self-audits using real board standards
  
  
• Build strong, defensible SOPs and training systems
  
  
• Respond to audit deficiencies with authority—not panic
  
  

Darshan Kulkarni, a pharmacist and regulatory attorney, brings practical, no-BS insight into what inspectors really expect and how to be prepared. Because waiting for an audit is like waiting for a hurricane to test your roof—too late.

Be ready. Be confident. Be compliant.

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In this video, Edye Edens and Darshan Kulkarni discuss whether sponsors, sites, CROs, or IRBs should self-report compliance issues. Edye, who focuses on sites, explains that whether or not to self-report is highly situation-dependent. Some situations legally require reporting, while in others, organizations might have room to implement corrective actions without immediate reporting—but they must carefully understand applicable regulations and enforcement trends.

Darshan highlights the distinction between “should you report” and “is it reportable.” Not everything unethical is legally reportable, but stakeholders must assess the risks of not reporting, including potential regulatory, investor, or reputational fallout. He also warns that just because an SOP says “do not report,” that might not align with current regulations or enforcement priorities—and could even expose the organization to greater liability.

The conversation also touches on recent Trump administration statements that encourage self-reporting by offering some protection from prosecution—though Edye cautions that administrations often shift their enforcement priorities, so organizations should not rely solely on these statements as a shield. Both agree that any self-reporting should be accompanied by a robust corrective action plan already underway to show good faith. Otherwise, agencies could still decide to prosecute, especially in egregious cases.

Bottom line:
 Self-reporting can build trust and potentially reduce penalties, but only if handled thoughtfully. Assess the legal requirements, business risks, and your agency’s enforcement climate before deciding to disclose.

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In this must-listen episode for pharma marketers and corporate counsel, we break down the recent $14.25M False Claims Act settlement involving Diopsys, a neurodiagnostic company accused of offering free tech to physicians—tech that allegedly led to medically unnecessary tests billed to Medicare and Medicaid.

This wasn’t just bad billing—it was a marketing strategy gone wrong. The DOJ saw it as a kickback scheme, and the case highlights how well-meaning “value-add” services can turn into legal liabilities.

Key takeaways:

• Value can become a liability – Helpful services may violate anti-kickback laws if not vetted legally.
  
  
• Volume-based strategies invite scrutiny – More testing isn’t always better—especially without medical necessity.
  
  
• You’re accountable—even if you don’t bill – Diopsys didn’t submit claims but still paid $14M for allegedly enabling them.
  
  

For legal and compliance teams, this is a compliance case study in what happens when oversight misses the risk signals. From fair market value to OIG advisory opinions—this episode explores what should have been done and how you can avoid the same fate.

Are your support services audit-proof? If you're unsure, this episode is for you. Tune in, stay informed, and stay compliant.

 Questions? Contact the Kulkarni Law Firm to assess your risk before you become the DOJ’s next target.

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In this episode, we talk to Martin Van Trieste about Civica Rx, nonprofit pharmaceutical company designed to address drug shortages in the U.S. The company focuses on sterile generics and biosimilars that have become economically unviable for other manufacturers. Initially operating as a broker, Civica transitioned into manufacturing, filing multiple ANDAs monthly and building a plant in West Virginia capable of producing 200 million doses annually. Civica's mission-driven approach includes transparency, cost-plus pricing with an 18–20% operating margin, and governance by health systems and philanthropic organizations to ensure adherence to its nonprofit goals.  

Civica recently expanded into biosimilar insulin production to combat high retail prices. While Civica is transparent with financials and prioritizes solving drug shortage problems, it avoids traditional retail models like memberships. Its innovations, such as labeling maximum retail prices on products, are supported by the FDA. Civica distinguishes itself by addressing systemic issues in the generic drug industry, emphasizing its commitment to solving problems over profit-making.

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In this discussion, Joseph Wolfson, an attorney at Stevens and Lee, and Darshan explore the intersection of law, marketing, and compliance in the pharmaceutical and medical device industries. Joe focuses on both antitrust litigation and advising private equity firms, pharmaceutical companies, and medical device companies on legal matters, particularly around unfair competition and antitrust concerns.

Joe explains how his firm helps private equity clients during the investment process by conducting due diligence, analyzing IP protection, and addressing potential FDA and marketing issues. Post-investment, the firm often acts as outside general counsel for the medical device or pharmaceutical companies, ensuring they stay compliant while maximizing shareholder value.

A key focus of the conversation is the complex regulatory landscape for medical products, where both the FDA and FTC play critical roles. While the FDA regulates the safety and efficacy of products, the FTC ensures that marketing practices do not mislead consumers. State Attorneys General (AGs) also play a role in protecting consumers, though their jurisdiction can differ depending on the state. Joe stresses that companies need to be aware of the overlapping but distinct concerns from these agencies when marketing their products.

Joe also highlights the ongoing risks of non-compliant marketing, specifically discussing litigation related to false advertising and misleading claims under the Lanham Act, as well as consumer litigation for personal injury claims arising from product misuse or misrepresentation.

Finally, Joe offers advice for marketers, emphasizing the importance of distinguishing between "puffery" (subjective opinions) and factual claims, especially in advertising. He warns companies to be able to back up any factual claims with solid evidence, as misleading marketing can lead to serious legal consequences. 

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In this episode, Darshan Kulkarni and Edye Edens explore whether sites should consider whistleblowing on non-compliant sponsors. They acknowledge that non-compliance is a non-negotiable issue, but emphasize the difficulty of deciding when to report, especially given the financial and relational ties between sites and sponsors.

They discuss examples, like overpayments or data integrity violations, which might compel a whistleblower to act. However, they highlight the gray areas where judgment calls blur the lines between compliance and ethical obligations. Both caution that despite legal protections, whistleblowers often find themselves unemployable in the industry afterward.

Darshan and Edye stress the importance of thoughtful, informed decision-making, advising that while some situations clearly demand reporting, others might warrant cautious documentation and internal discussion first. They underscore that reporting mechanisms vary—from internal sponsor compliance officers to IRBs, FDA, or even the Attorney General’s office—depending on the severity of the issue.

Ultimately, they urge potential whistleblowers to weigh the risks carefully, seek legal advice, and remember that every situation is unique.

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In this episode, Darshan Kulkarni sits down with Marie Ange Noue, Senior Director and Head of Scientific Communications at EMD Serono, to dive deep into the increasingly common practice of medical affairs teams creating dedicated LinkedIn handles.

Marie explains that this trend is driven by healthcare professionals’ evolving preferences for receiving medical information—today, over 70% prefer digital formats, and more than 50% use LinkedIn to connect, exchange ideas, and consume scientific content. She emphasizes that separate medical affairs handles allow companies to share timely, scientifically accurate, and balanced information, while avoiding the noise and promotional tone often associated with corporate or commercial channels.

They also discuss the regulatory implications of having a medical affairs presence on LinkedIn. Darshan raises the potential for confusion between promotional and non-promotional content, noting that regulatory frameworks like FDA’s promotional guidance (e.g., SIU, CME guidance) may not fully address the nuances of social media engagement by medical affairs teams. Marie acknowledges this challenge and highlights the importance of developing robust standard operating procedures (SOPs), collaboration across medical, legal, and regulatory (MLR) functions, and having clear disclaimers and labeling on posts to distinguish them as scientific communications.

The conversation covers the need for rigorous content governance, with Marie stressing that even purely scientific posts often undergo full MLR review at larger organizations like EMD Serono. Darshan points out that some smaller companies might adopt a medical review-only approach, but Marie cautions that given the speed and visibility of digital content, a thorough MLR process helps ensure compliance and trust.

They also discuss potential risks such as brand dilution and internal confusion about the official voice of the company on LinkedIn. Marie suggests that dedicated medical affairs handles can actually strengthen brand credibility by providing a trusted, consistent source of high-quality, scientific information tailored for healthcare professionals.

Darshan and Marie agree that this trend toward dedicated medical affairs social media channels reflects a broader transformation in how the pharmaceutical industry communicates with healthcare professionals—driven by digital expectations, regulatory complexities, and the need to provide meaningful, unbiased scientific content.

Marie closes by encouraging listeners to connect with her on LinkedIn to continue the conversation.

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In this episode, Edye and Darshan dive into the controversial but critical question: Are we paying patients enough to participate in clinical trials? And if not, how can we ethically and compliantly pay them more?

Key Takeaways:

1. The Coercion Concern
    Compensation 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 unduly influence a participant’s decision.
   
   
2. But Patients Face Real Burdens
    Participating in a trial is often time-consuming, emotionally taxing, and logistically difficult. Compensation is not just an incentive—it's a recognition of the burden placed on participants. Yet current payments often fail to account for this.
   
   
3. A Global Recruitment Crisis
    Across all demographics and trial types, the number one reason for trial failure is lack of patient recruitment. Fair compensation could help address this issue—if it can be done without violating regulations.
   
   
4. Legal Barriers: Beyond Coercion
    Darshan brings up beneficiary inducement laws, which restrict offering anything of value to influence a person’s use of a federally reimbursable product. While originally designed for approved treatments, there’s increasing concern that these rules could be applied to clinical trial recruitment efforts as well—particularly when sponsors fund community health services or resources tied to participation.
   
   
5. Real-World Examples Highlight Complexity
    While something like giving out muffins after a visit isn’t likely to raise flags, some site networks market clinical trials in low-income communities by promising access to healthcare that’s otherwise unavailable, which could cross into inducement territory. And this practice is far more common than many realize.
   
   
6. Sponsors vs. Sites
    Sponsors may be unaware of how their budgets are used downstream by sites, but they can still be held accountable. Because sites act as pass-through entities, improper use of funds for inducement can reflect back on the sponsor.
   
   
7. Practical Path Forward: A Data-Driven Model
    Instead of assigning arbitrary amounts, the speakers suggest using data:
   
   
   • Average wage in the region
     
     
   • Cost of living
     
     
   • Lost wages due to trial participation
     
     
   • Travel and time burdens
     
     
8. A standardized but flexible model could provide equitable compensation without crossing legal or ethical lines.
   
   
9. Time for a New Standard
    The speakers argue that the current standards around coercion and compensation are outdated and inconsistent. With no clear guidance from regulators, decisions often fall to IRBs, who base them on precedent rather than science or patient-centered logic.
   
   

Conclusion:
 Most would agree patients aren’t being paid enough for their participation. But increasing compensation isn't just a matter of kindness—it's a compliance challenge. The solution lies in balancing fair compensation with clear regulatory guidance. That means moving beyond fear of coercion to thoughtful, data-informed compensation models that reflect the realities of participation today.

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Google’s 2024 ad safety report just sent shockwaves through the pharma and device industries. With AI now faster, smarter, and more ruthless, Google blocked over 5.1 billion ads last year and restricted 9.1 billion more. Healthcare ads were hit especially hard, with over 106 million healthcare and medicine ads being blocked. If you’re still relying on old review systems or outdated playbooks, you’re in trouble—Google’s new AI can spot violations at lightning speed, often before you even see it. Ads can be blocked mid-upload, campaigns can collapse without warning, and Google now judges not just the content but your business practices—anything from a bad landing page to an imperfect payment system could lead to a suspension.

The report also revealed that in 2024 alone, Google suspended a staggering 39.2 million advertiser accounts, with identity verification now mandatory for over 90% of live ads. The stakes are higher than ever: if your ad has even the smallest imperfection, like a misleading claim or missing disclosure, Google’s AI will find it—and it will act fast. To survive in this new environment, pharma and device marketers must adapt immediately.

Here’s what you must do to stay in the game:

1. Rebuild your review process – Think like Google’s AI. Test every ad for potential violations and ensure no ad slips through without rigorous scrutiny.
   
   
   
2. Avoid vague or risky language – No more overpromising or claims without solid regulatory backup. Be literal, clear, and backed by evidence.
   
   
   
3. Expect ad rejections – Budget for 10-20% fallout rate and build in time for appeals.
   
   
   
4. Have backup campaigns – Don’t rely solely on Google. Build redundancy across other platforms like Meta, LinkedIn, and even TV.

The new era of AI enforcement demands precision, compliance, and a willingness to play it safe. If you fail to evolve, you’ll risk public failure, budget losses, and potentially losing your market position. Adapt now or be left behind in this AI-driven world.

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In this episode Edye Edens and Darshan Kulkarni tackle a hot-button issue in clinical trials: Should all screen fails be paid for? The discussion was sparked by a recent wave of community questions and contract examples around this very topic.

From the sponsor’s perspective, concerns center around cost control and compliance. Sponsors fear that paying for every screen fail, without oversight, opens the door to unlimited financial exposure—and more dangerously, potential kickback violations. They emphasize the need for fair market value, capped budgets, and data-driven estimates of expected screen failure rates.

From the site’s perspective, there’s agreement: not all screen fails are avoidable, especially when a patient appears eligible but fails due to factors like lab results or genetic markers. Sites aren't asking for a blank check—they're asking for reasonable compensation when they've performed due diligence.

Together, we explore:

• Why defining a “well-intentioned” screen fail matters.
  
  
  
• How scientific and protocol-driven caps can align sponsor and site expectations.
  
  
  
• The role of legal and clinical experts in designing fair, compliant agreements.
  
  
  
• The compliance risks, especially under increased federal scrutiny in healthcare fraud.
  
  
  
• Why sites must talk to their PIs and be empowered to negotiate using data—not just accept arbitrary screen fail caps.
  
  

Ultimately, this episode calls for collaboration, transparency, and data-backed contract terms. By using available science and engaging clinical and legal expertise, sponsors and sites can protect patients, stay compliant, and build long-term trust.

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In this episode, we explore a crucial and timely issue: how the Trump administration’s approach to antitrust enforcement—combined with new state-level regulations—is creating a shifting legal environment for life sciences companies, especially those involved in mergers and acquisitions (M&A).

At the federal level, Assistant Attorney General Gail Slater, in her first major antitrust address, emphasized a renewed focus on strict legal enforcement. Rather than relying on expansive regulatory interpretations, the administration is doubling down on clear statutory authority. This signals a return to more traditional antitrust principles, with heightened scrutiny of M&A transactions that may limit competition or consolidate market power.

But the complexity doesn’t stop there.

On April 4, 2025, Washington State passed SB 5122, becoming the first state to mandate broad pre-merger notifications across all industries. Effective July 27, 2025, this law requires companies meeting specific criteria—such as having a Washington-based headquarters, generating over $25.3 million in state sales, and operating as a healthcare provider or organization—to submit their federal Hart-Scott-Rodino (HSR) filings to the state Attorney General’s Office. Although there’s no filing fee or mandatory waiting period, noncompliance can lead to civil penalties of up to $10,000 per day.

This development sets a precedent, and other states like New York and California are already considering similar requirements. Life sciences companies must now navigate a growing web of both federal and state-level antitrust obligations.

Key Implications for Life Sciences Companies:

1. More aggressive M&A oversight: Federal and state authorities are signaling stricter reviews, particularly in transactions involving healthcare players.
   
   
2. Multi-jurisdictional compliance risks: Companies operating across several states must track and comply with differing notification and filing obligations.
   
   
3. Operational readiness is essential: Internal legal and compliance teams need to coordinate more closely with business development to ensure smooth and compliant deal execution.
   
   

Strategic Recommendations:

• Antitrust Risk Assessments: Evaluate all proposed and ongoing transactions for potential red flags at both state and federal levels.
  
  
  
• Monitor Legislative Trends: Keep track of proposed laws in states like Massachusetts, California, and New York that may soon mirror Washington’s model.
  
  
  
• Strengthen Internal Protocols: Develop systems to ensure accurate, timely submissions of required documentation—both federally and at the state level.
  
  
  
• Engage Counsel Early: Legal teams should be involved at the earliest stages of deal structuring to identify issues before they escalate.
  
  

In an environment where both federal enforcers and state regulators are increasing scrutiny, proactive planning is critical. Companies that adapt quickly to these shifting expectations will be better positioned to manage risk and maintain momentum.

Stay tuned for our next episode as we continue exploring the legal and regulatory trends shaping the pharmaceutical and life sciences industries.

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Transferring medical device ownership during a company sale requires careful planning to ensure compliance and operational continuity. The process begins with accurate documentation of 510(k) clearance and thorough due diligence to avoid regulatory delays. Next, companies must assess ongoing clinical trial responsibilities and contractual obligations tied to the device. Compliance programs should align with both the 2024 DOJ and OIG guidelines to demonstrate regulatory commitment. Conducting a comprehensive gap analysis helps identify compliance risks before the sale. The FDA ownership transfer registration is essential to prevent operational disruptions, along with any necessary state-level reporting. Lastly, a clear agreement outlining contract disputes, pharmacovigilance, transition terms, and quality agreements is crucial to avoid post-sale legal issues.

For expert guidance, Kulkarni Law Firm helps FDA-regulated companies navigate this process smoothly. Contact us to safeguard your business.

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At first glance, responding to site-level findings seems simple—but when Edye and Darshan dug into the details, it became clear that the lines of responsibility blur fast. Here's how each side sees it:

Site Perspective:

Sites know the boots-on-the-ground reality. When a finding is made—especially during an external inspection like the FDA—they’re often the ones best positioned to analyze what went wrong.
 The site team (usually led by QA or compliance professionals) needs to:

• Conduct a root cause analysis
  
  
• Propose corrective and preventive actions (CAPAs)
  
  
• Coordinate with the Principal Investigator (PI), who should always be aware of and often sign off on the response
  
  
• Demonstrate that they are taking ownership of the issue
  
  

But here’s the challenge: responding without oversharing or accidentally implicating the sponsor/CRO can be tricky. Sites want autonomy, but also need alignment to avoid missteps.

Sponsor/CRO Perspective:

Sponsors and CROs carry the risk for the overall study. So if a site submits a response that reflects poorly on the sponsor—whether intentionally or not—that’s a problem.
 From their perspective, they want:

• Visibility into the response, especially if it relates to protocol design, training, or oversight
  
  
• The ability to review and edit before submission, to avoid legal or regulatory fallout
  
  
• Assurance that site responses don't point fingers at them unnecessarily
  Sponsors also need to assess if the issue points to a breakdown in their own oversight—and if so, they must acknowledge and fix it. But as Darshan pointed out, no sponsor wants to "sink so the site can swim." It’s about mutual accountability.

The Real Answer: "It Depends"

Whether a finding is the site's responsibility or the sponsor’s comes down to the root cause:

• Did the site fail to follow their SOPs or hire unqualified staff? That’s on the site.
  
  
• Did the sponsor fail to provide adequate training or resources? That’s on the sponsor/CRO.
  
  

Both Edye and Darshan agree: most findings land in a gray zone. That’s why collaboration, transparency, and clear communication are key.

Want more of these insights? Let us know—we’ve got more hot topics on deck. 

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Medical communications teams must exercise caution when using websites dedicated to medical affairs, as legal risks go beyond overt sales promotion. Drug and device manufacturers face compliance challenges, particularly when these platforms are accessed by broader audiences, including non-scientists.

Key risks include:

• Off-Label Promotion: The Facteau case highlights how communications implying off-label use can lead to violations under the Food, Drug, and Cosmetic Act, even for FDA-cleared devices.
• Improper Audience Targeting: Specialized medical affairs websites are intended for healthcare professionals. If content inadvertently targets patients or the general public, it may be deemed promotional, violating FDA rules.

To mitigate risks, companies should:

1. Clearly define intended use and avoid statements endorsing unapproved applications.
2. Consider separate patient engagement pages to keep medical affairs content professional and compliant.
3. Regularly review communication strategies in light of evolving guidance, such as the CFL and SIUU Guidance, and recent legal decisions like Loper Bright.

The $3 billion GSK settlement underscores the stakes—misbranding, off-label promotion, and audience misalignment can result in severe penalties and reputational harm. Manufacturers should seek expert legal counsel, like the Kulkarni Law Firm, to ensure compliance and safeguard against regulatory risks.

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At the Save Our Sites (SOS) conference, many site owners expressed excitement over finally having a space to openly discuss real challenges—budgets, pricing, contracting, and the isolation of being a site owner. While the intent was mutual support, concerns quickly arose when some attendees began advocating for standardized pricing across sites (e.g., "$200 for an X-ray")—a move that borders on illegal price fixing.

Darshan raised red flags, emphasizing that while site collaboration is valuable, actions like setting uniform pricing or paying for patient referrals can violate antitrust and anti-kickback laws. Edye pointed out that many site owners, especially those without traditional academic or regulatory backgrounds, may genuinely not know these rules.

They agreed: sites need spaces for community and education, but must distinguish between support networks and collective negotiation efforts—especially since the latter may trigger legal concerns such as RICO violations or be misinterpreted as forming a union. The bottom line? Intent isn’t enough. Awareness and compliance matter.

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