At the Save Our Sites (SOS) conference, many site owners expressed excitement over finally having a space to openly discuss real challenges—budgets, pricing, contracting, and the isolation of being a site owner. While the intent was mutual support, concerns quickly arose when some attendees began advocating for standardized pricing across sites (e.g., "$200 for an X-ray")—a move that borders on illegal price fixing.

Darshan raised red flags, emphasizing that while site collaboration is valuable, actions like setting uniform pricing or paying for patient referrals can violate antitrust and anti-kickback laws. Edye pointed out that many site owners, especially those without traditional academic or regulatory backgrounds, may genuinely not know these rules.

They agreed: sites need spaces for community and education, but must distinguish between support networks and collective negotiation efforts—especially since the latter may trigger legal concerns such as RICO violations or be misinterpreted as forming a union. The bottom line? Intent isn’t enough. Awareness and compliance matter.

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The recent conviction of a Michigan pharmacist and his brother in a $15 million healthcare fraud scheme highlights the growing crackdown on pharmacy-related fraud. The scheme involved billing for medications that were never dispensed, targeting Medicare, Medicaid, and private insurance. This pattern of fraud is not new, as the Department of Justice (DOJ) recently charged nearly 200 individuals in similar cases amounting to $2.75 billion in fraud claims. Pharmacies, both large and small, are increasingly under scrutiny as enforcement agencies widen their focus.

For pharmacists, compliance officers, and legal professionals working with pharmacies, this trend serves as a reminder that even small lapses in billing, documentation, or deadlines can lead to major legal consequences. The DOJ is committed to ensuring the integrity of taxpayer-funded healthcare programs, meaning minor non-compliance could result in severe penalties. With large corporations like Walgreens paying millions to settle fraud claims, it's clear that all pharmacies are at risk. To protect your business, it's crucial to implement a strong compliance program, conduct thorough audits, and train your team on the latest regulations.

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Pharma is finally catching up to the on-demand world—offering direct-to-patient (DTP) services that promise convenience, faster delivery, and a more personalized experience. Major players like Pfizer, Lilly, and Novo Nordisk are leading the way, cutting out intermediaries like pharmacists, PBMs, and even traditional physicians.

But convenience comes at a cost.

By removing these safeguards, companies take on massive compliance liabilities. Telehealth prescribing raises serious questions around physician independence and anti-kickback regulations. Fulfillment introduces risks tied to product integrity, recalls, and data privacy. Even cash-based payments can trigger transparency violations and pricing scrutiny.

The risks are real: HIPAA breaches, malpractice claims, and federal investigations can derail even the most well-meaning DTP strategies. That’s why pharmaceutical companies must treat compliance as foundational—not an afterthought.

The path forward? Define clear boundaries between pharma, prescribers, and delivery partners. Invest in internal audits. Build scenario-based risk plans. And most importantly, bring legal and compliance professionals to the table from day one.

At Kulkarni Law Firm, we specialize in helping pharma companies innovate without compromising compliance. If your organization is exploring or expanding its DTP strategy, let’s make sure you’re protected—before risks become reality.

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Today, we're diving into a hot topic in clinical trials: should you use AI to negotiate your next clinical trial agreement? Darshan is joined by Elizabeth from the University of Cincinnati and Istvan Fekete from Huron Consulting, who share their experiences and thoughts on using AI for contract and budget negotiations. They discuss the potential and limits of AI, highlighting concerns over copyright, data ownership, and "black box" decision-making. While AI can streamline contract review with tools like word plugins, there's consensus that human oversight will remain crucial. AI can help create initial drafts and flag key points, but will people over-rely on it, missing critical details in the process?

Istvan emphasizes that even with AI assistance, human expertise in contract review remains irreplaceable. Elizabeth raises a thought-provoking question: Will AI reduce the number of people at conferences like Magi in ten years, or will it expand the industry as AI tools increase contract efficiency? We’ll find out!

#AI #clinicaltrials #clinicalresearch #AIinclinicaltrials #pharmainnovation #smartnegotiations #legalinnovation #contractnegotiation #clinicaltrialtech #clinicaltrialagreements #pharmaregulations #clinicaltrialtech #darshantalks #dt #kulkarnilawfirm #klf #recentrecap

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In this discussion, Edye Edens and Darshan Kulkarni tackle one of the most common questions in clinical research: How many SOPs should a site have? While many assume a fixed number like 12, the reality is more nuanced.

From a site perspective, having extensive SOPs can feel overwhelming, but they are essential for compliance and audits. SOPs are the first thing requested during inspections by the FDA or sponsors. However, sites must strike a balance—too few SOPs indicate a lack of structure, while too many can create unnecessary complexity.

For IRBs, SOPs are a given, as they must document their policies for both internal staff and external researchers.

Sponsors and CROs also rely on SOPs to ensure patient safety and regulatory compliance. They don’t necessarily need extreme detail, but they do need a clear framework to verify consistent procedures.

Key takeaways:

• SOPs should set a structured, repeatable process—not be reactive documents.
• Having too few SOPs signals weak compliance; having too many leads to contradictions.
• M&A buyers and private equity firms look for strong SOP structures when acquiring research sites.
• AI and shared templates can help, but SOPs must be customized and regularly updated.

For new sites, a starting range of 5–10 SOPs is reasonable, expanding to 10–20+ SOPs as operations grow. Ultimately, SOPs should be strategic, practical, and tailored to the site's needs—ensuring compliance without unnecessary burden.

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In a recent interview between Nirpal Virdee and Darshan Kulkarni, they discussed the ongoing shifts in the pharmaceutical industry, particularly the rise of Direct-to-Patient (DTP) models. The conversation explored how these changes are driven by the pressure to reduce drug and device costs, especially in light of new tariffs that could further escalate prices. Darshan emphasized the need for pharmaceutical companies to rethink their operational models, including cutting out intermediaries to bring down costs while still optimizing patient engagement.

The role of AI was also debated. While AI is seen as a potential tool for enhancing efficiency—particularly in areas like data collection and personalized patient care—Darshan noted that AI's impact will be limited in the short term due to concerns around transparency in decision-making. However, AI could still provide valuable opportunities, especially for on-demand answers and information retrieval.

The discussion also delved into the complexities of creating a successful DTP model. Issues like patient steering, agency problems, and the risk of false claims were highlighted as potential pitfalls that companies must navigate carefully. Darshan pointed out that this new direct-to-patient approach requires clear strategies to avoid legal issues while delivering a better patient experience.

Both Nirpal and Darshan agreed that while the pharmaceutical industry is undergoing a significant evolution, it is far from a simple trend. DTP represents a fundamental shift in how patients interact with pharma companies, and while the future is uncertain, the changes have the potential to be revolutionary—especially in terms of improving patient engagement and reducing healthcare costs.

The interview concluded with both experts emphasizing the importance of compliance and trust in these new models, with Darshan stressing that regulatory frameworks would need to adapt to these innovations in order to ensure long-term value for both patients and pharmaceutical companies.

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Health records are one of the top targets for hackers. These records contain a wealth of personal information like Social Security numbers, insurance details, and medical history, making them a gold mine for cybercriminals. Hackers use this data to steal identities, open credit cards, and even file fake tax returns. The scariest part? They can create fake identities for illegal activities, such as drug purchases or money laundering.

Why does this happen? Healthcare organizations often rely on outdated technology, making them vulnerable to attacks. Hackers exploit these weaknesses, and because the stakes are high, hospitals are sometimes forced to pay ransoms to recover their systems quickly, which only encourages more attacks. What can be done? Healthcare companies must enhance cybersecurity, using advanced tools, training employees, and educating patients on protecting their data. Governments also need to tighten regulations and enforce harsher penalties for breaches. Do you think healthcare organizations should be fined for data protection failures?

Share your thoughts below. If you're a healthcare company concerned about your data security, the Kulkarni Law Firm is here to help. Reach out today to protect your systems and maintain patient trust.

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We unpack the $202 million storm surrounding Gilead’s so-called “educational” speaker programs — and why it should make every medical affairs, legal, marketing, and compliance professional sit up straight.

Here’s what happened: The DOJ alleged that Gilead turned 17,000 speaker programs into a covert marketing machine to boost HIV drug prescriptions. We’re not talking about the occasional misstep — we’re talking wine-paired steak dinners at the James Beard House, prescribers being paid over $300,000 in honoraria, and attendees showing up to the same slide deck as many as 75 times.

The DOJ didn’t just scrutinize sales teams — they dug into how speakers were selected, how events were structured, who was invited, and how the money flowed. Internal emails revealed that many of these speakers weren’t chosen for their expertise, but for their prescription power — flagged as “must-win” accounts.

If you’re defending your program by saying, “But it’s educational,” this episode is your wake-up call. The DOJ doesn’t care about the label. They care about intent, patterns, and whether your slide decks are being used to deliver education — or scripts.

We go deep on how these programs can quietly cross legal lines, how even well-meaning compliance teams can fail when oversight becomes performative, and what questions you should be asking right now. Because if your MSLs choose the speakers, your marketing team builds the decks, and your compliance team just rubber-stamps — your program might already be under the microscope.

Listen in to learn how to audit your current speaker programs, spot early red flags, and protect your company — and your career — before regulators come knocking.

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