DarshanTalks Podcast

Send us Fan Mail

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.

Support the show

www.kulkarnilawfirm.com

Send us Fan Mail

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.

Support the show

www.kulkarnilawfirm.com

Send us Fan Mail

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.

Support the show

www.kulkarnilawfirm.com

Send us Fan Mail

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.

Support the show

www.kulkarnilawfirm.com

Send us Fan Mail

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.

Support the show

www.kulkarnilawfirm.com

Send us Fan Mail

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.

Support the show

www.kulkarnilawfirm.com

Send us Fan Mail

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

www.kulkarnilawfirm.com

Send us Fan Mail

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

www.kulkarnilawfirm.com

Send us Fan Mail

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

www.kulkarnilawfirm.com

Send us Fan Mail

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

www.kulkarnilawfirm.com