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!

Support the show

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.

Support the show

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.

Support the show

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.

Support the show

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.

Like, comment, or reach out via LinkedIn.

Support the show

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.

Like, comment, or reach out via LinkedIn.

Support the show

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.

Like, comment, or reach out to learn more.

Support the show

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.

Support the show