DarshanTalks Podcast
Welcome to DarshanTalks!
We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!
Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do.
We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
Episodes
266 episodes
Marketing Problems by Hims & Hers and Lilly
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 telehealt...
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3:45
Should Sponsors Share Site Feedback?
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...
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4:53
AI Marketing Playbook for Drug Companies
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 spee...
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3:30
Should Sites Be Ready on Standby?
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 tr...
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5:24
Eastern District of PA Targets Pharmacies
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...
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0:43
Telehealth Done Right
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 s...
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3:32
DOJ and HHS Launch FCA Fraud Task Force
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...
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6:20
Should Sponsors Cover Malpractice Insurance?
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 sim...
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4:13
Instagram Post that Sparked FDA Warning Letter
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 bu...
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4:44
Why Are So Many Doctors Getting Arrested?
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 Just...
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4:26
How to Run Compliant Pharma Speaker Programs
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 ...
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7:54
Are You Picking the Wrong KOLs?
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—especial...
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4:28
How KLF’s Client Base Evolved Over 20 Years
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 e...
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5:13
FDA Pushback on Accelerated Gene Therapy Approvals
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 incompl...
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4:10
Your DEI Program Could Trigger an FCA Case
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 ...
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6:04
Teva’s Charity Partnership Scrutinized
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 inten...
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2:20
Is There a “Right” Way to Calculate FMV?
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 prev...
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12:50
Can Non-Physicians Own Clinical Trial Sites?
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 adhe...
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3:35
The KLF Story You Haven’t Heard
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 shado...
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8:35
Why Telehealth Platforms Are Getting Sued
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 c...
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6:05
Should Clinical Trial Sites Be Paid Differently?
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 t...
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12:21
How to Build an AI Compliance Program
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 engagemen...
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5:46
What the Big Beautiful Bill Means for Trial Sites
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 refer...
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5:06