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
282 episodes
Payer Presentations Can Trigger Enforcement
The boundary between scientific exchange and marketing in payer presentations is increasingly blurred, creating significant compliance and enforcement risks. While payers demand real-world evidence, comparative studies, and economic models b...
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6:00
Pharmacies v manufacturers
In this episode, Darshan Kulkarni speaks with Dae Lee about the growing conflict between pharmaceutical manufacturers and pharmacy benefit managers (PBMs) — and how it’s reshaping the U.S. drug supply chain.They unpack the rece...
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11:56
Is Clinical Research Ready for the new FDA?
The FDA has criticized the industry for not taking advertising and promotion seriously and is now cracking down, as evidenced by hundreds of non-compliance letters. This raises the question: if similar scrutiny applied to clinical research, ...
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0:58
Is your cosmetics company FDA-registered?
Cosmetics companies must now register both their facilities and products with the FDA under the new MoCRArequirements, a shift from the previous voluntary system. Each facility must register, and product listings — including categories, ingr...
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1:06
Will AI Replace Doctors in clinical research?
Darshan discusses the potential role of AI in medicine. He believes fears of AI replacing doctors for diagnosis are currently overblown, as trust in physicians remains crucial. However, he suggests AI could assist with preliminary research t...
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0:51
Risks in Direct-to-Patient Engagement
Direct-to-Patient (DTP) models are transforming how medications reach patients, moving beyond clinical research into commercial distribution. Originally developed to help rare disease trial participants avoid long travel to research sites, D...
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2:49
Inside 340B: Challenges, Controversies, and Opportunities
Darshan Kulkarni speaks with Thomas Siepka, CEO of HCI Healthcare Consultants, to take a deep dive into the often-misunderstood world of the 340B drug pricing program. Drawing on Siepka’s extensive experience as a pharmacist and healthcare l...
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14:43
IRBs in 2025: What’s Really Changing?
In this conversation, Edye Edens with Nyssa Towsley from UNLV, examine how today’s shifting funding landscape is reshaping IRB operations. Historically, IRBs were built around the assumption that most research would be government-funded. Tha...
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5:41
3 Red Flags in Telemedicine Partnerships
In this video, Darshan discusses recent enforcement trends show three weak spots to watch:Encounter Quality – If prescribers are just checking boxes without real patient relationships, it’s not care—it’s exposure. Demand d...
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2:49
What do PBMs do?
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, sh...
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12:29
How AMCs Build Stronger Compliance Cultures Together
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 as...
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10:49
How One DME Scheme Cost Medicare $61 Million
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 ...
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4:26
FDA to Step Up Enforcement on Pharma Advertising
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 tha...
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3:53
Top 5 Factors Determining AMC Funding
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 commer...
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8:54
New Series Drop: Exploring AMCs in Clinical Research
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,...
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9:44
Why Choose a Licensed Attorney Over a Consultant?
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:Privilege & Confiden...
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5:35
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