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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