In this episode, we talk to Martin Van Trieste about Civica Rx, nonprofit pharmaceutical company designed to address drug shortages in the U.S. The company focuses on sterile generics and biosimilars that have become economically unviable for other manufacturers. Initially operating as a broker, Civica transitioned into manufacturing, filing multiple ANDAs monthly and building a plant in West Virginia capable of producing 200 million doses annually. Civica's mission-driven approach includes transparency, cost-plus pricing with an 18–20% operating margin, and governance by health systems and philanthropic organizations to ensure adherence to its nonprofit goals.  

Civica recently expanded into biosimilar insulin production to combat high retail prices. While Civica is transparent with financials and prioritizes solving drug shortage problems, it avoids traditional retail models like memberships. Its innovations, such as labeling maximum retail prices on products, are supported by the FDA. Civica distinguishes itself by addressing systemic issues in the generic drug industry, emphasizing its commitment to solving problems over profit-making.

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In this discussion, Joseph Wolfson, an attorney at Stevens and Lee, and Darshan explore the intersection of law, marketing, and compliance in the pharmaceutical and medical device industries. Joe focuses on both antitrust litigation and advising private equity firms, pharmaceutical companies, and medical device companies on legal matters, particularly around unfair competition and antitrust concerns.

Joe explains how his firm helps private equity clients during the investment process by conducting due diligence, analyzing IP protection, and addressing potential FDA and marketing issues. Post-investment, the firm often acts as outside general counsel for the medical device or pharmaceutical companies, ensuring they stay compliant while maximizing shareholder value.

A key focus of the conversation is the complex regulatory landscape for medical products, where both the FDA and FTC play critical roles. While the FDA regulates the safety and efficacy of products, the FTC ensures that marketing practices do not mislead consumers. State Attorneys General (AGs) also play a role in protecting consumers, though their jurisdiction can differ depending on the state. Joe stresses that companies need to be aware of the overlapping but distinct concerns from these agencies when marketing their products.

Joe also highlights the ongoing risks of non-compliant marketing, specifically discussing litigation related to false advertising and misleading claims under the Lanham Act, as well as consumer litigation for personal injury claims arising from product misuse or misrepresentation.

Finally, Joe offers advice for marketers, emphasizing the importance of distinguishing between "puffery" (subjective opinions) and factual claims, especially in advertising. He warns companies to be able to back up any factual claims with solid evidence, as misleading marketing can lead to serious legal consequences. 

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In this episode, Darshan Kulkarni and Edye Edens explore whether sites should consider whistleblowing on non-compliant sponsors. They acknowledge that non-compliance is a non-negotiable issue, but emphasize the difficulty of deciding when to report, especially given the financial and relational ties between sites and sponsors.

They discuss examples, like overpayments or data integrity violations, which might compel a whistleblower to act. However, they highlight the gray areas where judgment calls blur the lines between compliance and ethical obligations. Both caution that despite legal protections, whistleblowers often find themselves unemployable in the industry afterward.

Darshan and Edye stress the importance of thoughtful, informed decision-making, advising that while some situations clearly demand reporting, others might warrant cautious documentation and internal discussion first. They underscore that reporting mechanisms vary—from internal sponsor compliance officers to IRBs, FDA, or even the Attorney General’s office—depending on the severity of the issue.

Ultimately, they urge potential whistleblowers to weigh the risks carefully, seek legal advice, and remember that every situation is unique.

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In this episode, Darshan Kulkarni sits down with Marie Ange Noue, Senior Director and Head of Scientific Communications at EMD Serono, to dive deep into the increasingly common practice of medical affairs teams creating dedicated LinkedIn handles.

Marie explains that this trend is driven by healthcare professionals’ evolving preferences for receiving medical information—today, over 70% prefer digital formats, and more than 50% use LinkedIn to connect, exchange ideas, and consume scientific content. She emphasizes that separate medical affairs handles allow companies to share timely, scientifically accurate, and balanced information, while avoiding the noise and promotional tone often associated with corporate or commercial channels.

They also discuss the regulatory implications of having a medical affairs presence on LinkedIn. Darshan raises the potential for confusion between promotional and non-promotional content, noting that regulatory frameworks like FDA’s promotional guidance (e.g., SIU, CME guidance) may not fully address the nuances of social media engagement by medical affairs teams. Marie acknowledges this challenge and highlights the importance of developing robust standard operating procedures (SOPs), collaboration across medical, legal, and regulatory (MLR) functions, and having clear disclaimers and labeling on posts to distinguish them as scientific communications.

The conversation covers the need for rigorous content governance, with Marie stressing that even purely scientific posts often undergo full MLR review at larger organizations like EMD Serono. Darshan points out that some smaller companies might adopt a medical review-only approach, but Marie cautions that given the speed and visibility of digital content, a thorough MLR process helps ensure compliance and trust.

They also discuss potential risks such as brand dilution and internal confusion about the official voice of the company on LinkedIn. Marie suggests that dedicated medical affairs handles can actually strengthen brand credibility by providing a trusted, consistent source of high-quality, scientific information tailored for healthcare professionals.

Darshan and Marie agree that this trend toward dedicated medical affairs social media channels reflects a broader transformation in how the pharmaceutical industry communicates with healthcare professionals—driven by digital expectations, regulatory complexities, and the need to provide meaningful, unbiased scientific content.

Marie closes by encouraging listeners to connect with her on LinkedIn to continue the conversation.

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In this episode, Edye and Darshan dive into the controversial but critical question: Are we paying patients enough to participate in clinical trials? And if not, how can we ethically and compliantly pay them more?

Key Takeaways:

1. The Coercion Concern
    Compensation for trial participation is often scrutinized by IRBs due to concerns around coercion. Historically, this concern stems from extreme abuses (e.g., experiments in Holocaust camps) and evolved to include more nuanced forms, such as overpromising benefits or targeting vulnerable populations. IRBs are cautious that financial incentives don’t unduly influence a participant’s decision.
   
   
2. But Patients Face Real Burdens
    Participating in a trial is often time-consuming, emotionally taxing, and logistically difficult. Compensation is not just an incentive—it's a recognition of the burden placed on participants. Yet current payments often fail to account for this.
   
   
3. A Global Recruitment Crisis
    Across all demographics and trial types, the number one reason for trial failure is lack of patient recruitment. Fair compensation could help address this issue—if it can be done without violating regulations.
   
   
4. Legal Barriers: Beyond Coercion
    Darshan brings up beneficiary inducement laws, which restrict offering anything of value to influence a person’s use of a federally reimbursable product. While originally designed for approved treatments, there’s increasing concern that these rules could be applied to clinical trial recruitment efforts as well—particularly when sponsors fund community health services or resources tied to participation.
   
   
5. Real-World Examples Highlight Complexity
    While something like giving out muffins after a visit isn’t likely to raise flags, some site networks market clinical trials in low-income communities by promising access to healthcare that’s otherwise unavailable, which could cross into inducement territory. And this practice is far more common than many realize.
   
   
6. Sponsors vs. Sites
    Sponsors may be unaware of how their budgets are used downstream by sites, but they can still be held accountable. Because sites act as pass-through entities, improper use of funds for inducement can reflect back on the sponsor.
   
   
7. Practical Path Forward: A Data-Driven Model
    Instead of assigning arbitrary amounts, the speakers suggest using data:
   
   
   • Average wage in the region
     
     
   • Cost of living
     
     
   • Lost wages due to trial participation
     
     
   • Travel and time burdens
     
     
8. A standardized but flexible model could provide equitable compensation without crossing legal or ethical lines.
   
   
9. Time for a New Standard
    The speakers argue that the current standards around coercion and compensation are outdated and inconsistent. With no clear guidance from regulators, decisions often fall to IRBs, who base them on precedent rather than science or patient-centered logic.
   
   

Conclusion:
 Most would agree patients aren’t being paid enough for their participation. But increasing compensation isn't just a matter of kindness—it's a compliance challenge. The solution lies in balancing fair compensation with clear regulatory guidance. That means moving beyond fear of coercion to thoughtful, data-informed compensation models that reflect the realities of participation today.

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Google’s 2024 ad safety report just sent shockwaves through the pharma and device industries. With AI now faster, smarter, and more ruthless, Google blocked over 5.1 billion ads last year and restricted 9.1 billion more. Healthcare ads were hit especially hard, with over 106 million healthcare and medicine ads being blocked. If you’re still relying on old review systems or outdated playbooks, you’re in trouble—Google’s new AI can spot violations at lightning speed, often before you even see it. Ads can be blocked mid-upload, campaigns can collapse without warning, and Google now judges not just the content but your business practices—anything from a bad landing page to an imperfect payment system could lead to a suspension.

The report also revealed that in 2024 alone, Google suspended a staggering 39.2 million advertiser accounts, with identity verification now mandatory for over 90% of live ads. The stakes are higher than ever: if your ad has even the smallest imperfection, like a misleading claim or missing disclosure, Google’s AI will find it—and it will act fast. To survive in this new environment, pharma and device marketers must adapt immediately.

Here’s what you must do to stay in the game:

1. Rebuild your review process – Think like Google’s AI. Test every ad for potential violations and ensure no ad slips through without rigorous scrutiny.
   
   
   
2. Avoid vague or risky language – No more overpromising or claims without solid regulatory backup. Be literal, clear, and backed by evidence.
   
   
   
3. Expect ad rejections – Budget for 10-20% fallout rate and build in time for appeals.
   
   
   
4. Have backup campaigns – Don’t rely solely on Google. Build redundancy across other platforms like Meta, LinkedIn, and even TV.

The new era of AI enforcement demands precision, compliance, and a willingness to play it safe. If you fail to evolve, you’ll risk public failure, budget losses, and potentially losing your market position. Adapt now or be left behind in this AI-driven world.

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In this episode Edye Edens and Darshan Kulkarni tackle a hot-button issue in clinical trials: Should all screen fails be paid for? The discussion was sparked by a recent wave of community questions and contract examples around this very topic.

From the sponsor’s perspective, concerns center around cost control and compliance. Sponsors fear that paying for every screen fail, without oversight, opens the door to unlimited financial exposure—and more dangerously, potential kickback violations. They emphasize the need for fair market value, capped budgets, and data-driven estimates of expected screen failure rates.

From the site’s perspective, there’s agreement: not all screen fails are avoidable, especially when a patient appears eligible but fails due to factors like lab results or genetic markers. Sites aren't asking for a blank check—they're asking for reasonable compensation when they've performed due diligence.

Together, we explore:

• Why defining a “well-intentioned” screen fail matters.
  
  
  
• How scientific and protocol-driven caps can align sponsor and site expectations.
  
  
  
• The role of legal and clinical experts in designing fair, compliant agreements.
  
  
  
• The compliance risks, especially under increased federal scrutiny in healthcare fraud.
  
  
  
• Why sites must talk to their PIs and be empowered to negotiate using data—not just accept arbitrary screen fail caps.
  
  

Ultimately, this episode calls for collaboration, transparency, and data-backed contract terms. By using available science and engaging clinical and legal expertise, sponsors and sites can protect patients, stay compliant, and build long-term trust.

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In this episode, we explore a crucial and timely issue: how the Trump administration’s approach to antitrust enforcement—combined with new state-level regulations—is creating a shifting legal environment for life sciences companies, especially those involved in mergers and acquisitions (M&A).

At the federal level, Assistant Attorney General Gail Slater, in her first major antitrust address, emphasized a renewed focus on strict legal enforcement. Rather than relying on expansive regulatory interpretations, the administration is doubling down on clear statutory authority. This signals a return to more traditional antitrust principles, with heightened scrutiny of M&A transactions that may limit competition or consolidate market power.

But the complexity doesn’t stop there.

On April 4, 2025, Washington State passed SB 5122, becoming the first state to mandate broad pre-merger notifications across all industries. Effective July 27, 2025, this law requires companies meeting specific criteria—such as having a Washington-based headquarters, generating over $25.3 million in state sales, and operating as a healthcare provider or organization—to submit their federal Hart-Scott-Rodino (HSR) filings to the state Attorney General’s Office. Although there’s no filing fee or mandatory waiting period, noncompliance can lead to civil penalties of up to $10,000 per day.

This development sets a precedent, and other states like New York and California are already considering similar requirements. Life sciences companies must now navigate a growing web of both federal and state-level antitrust obligations.

Key Implications for Life Sciences Companies:

1. More aggressive M&A oversight: Federal and state authorities are signaling stricter reviews, particularly in transactions involving healthcare players.
   
   
2. Multi-jurisdictional compliance risks: Companies operating across several states must track and comply with differing notification and filing obligations.
   
   
3. Operational readiness is essential: Internal legal and compliance teams need to coordinate more closely with business development to ensure smooth and compliant deal execution.
   
   

Strategic Recommendations:

• Antitrust Risk Assessments: Evaluate all proposed and ongoing transactions for potential red flags at both state and federal levels.
  
  
  
• Monitor Legislative Trends: Keep track of proposed laws in states like Massachusetts, California, and New York that may soon mirror Washington’s model.
  
  
  
• Strengthen Internal Protocols: Develop systems to ensure accurate, timely submissions of required documentation—both federally and at the state level.
  
  
  
• Engage Counsel Early: Legal teams should be involved at the earliest stages of deal structuring to identify issues before they escalate.
  
  

In an environment where both federal enforcers and state regulators are increasing scrutiny, proactive planning is critical. Companies that adapt quickly to these shifting expectations will be better positioned to manage risk and maintain momentum.

Stay tuned for our next episode as we continue exploring the legal and regulatory trends shaping the pharmaceutical and life sciences industries.

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Transferring medical device ownership during a company sale requires careful planning to ensure compliance and operational continuity. The process begins with accurate documentation of 510(k) clearance and thorough due diligence to avoid regulatory delays. Next, companies must assess ongoing clinical trial responsibilities and contractual obligations tied to the device. Compliance programs should align with both the 2024 DOJ and OIG guidelines to demonstrate regulatory commitment. Conducting a comprehensive gap analysis helps identify compliance risks before the sale. The FDA ownership transfer registration is essential to prevent operational disruptions, along with any necessary state-level reporting. Lastly, a clear agreement outlining contract disputes, pharmacovigilance, transition terms, and quality agreements is crucial to avoid post-sale legal issues.

For expert guidance, Kulkarni Law Firm helps FDA-regulated companies navigate this process smoothly. Contact us to safeguard your business.

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At first glance, responding to site-level findings seems simple—but when Edye and Darshan dug into the details, it became clear that the lines of responsibility blur fast. Here's how each side sees it:

Site Perspective:

Sites know the boots-on-the-ground reality. When a finding is made—especially during an external inspection like the FDA—they’re often the ones best positioned to analyze what went wrong.
 The site team (usually led by QA or compliance professionals) needs to:

• Conduct a root cause analysis
  
  
• Propose corrective and preventive actions (CAPAs)
  
  
• Coordinate with the Principal Investigator (PI), who should always be aware of and often sign off on the response
  
  
• Demonstrate that they are taking ownership of the issue
  
  

But here’s the challenge: responding without oversharing or accidentally implicating the sponsor/CRO can be tricky. Sites want autonomy, but also need alignment to avoid missteps.

Sponsor/CRO Perspective:

Sponsors and CROs carry the risk for the overall study. So if a site submits a response that reflects poorly on the sponsor—whether intentionally or not—that’s a problem.
 From their perspective, they want:

• Visibility into the response, especially if it relates to protocol design, training, or oversight
  
  
• The ability to review and edit before submission, to avoid legal or regulatory fallout
  
  
• Assurance that site responses don't point fingers at them unnecessarily
  Sponsors also need to assess if the issue points to a breakdown in their own oversight—and if so, they must acknowledge and fix it. But as Darshan pointed out, no sponsor wants to "sink so the site can swim." It’s about mutual accountability.

The Real Answer: "It Depends"

Whether a finding is the site's responsibility or the sponsor’s comes down to the root cause:

• Did the site fail to follow their SOPs or hire unqualified staff? That’s on the site.
  
  
• Did the sponsor fail to provide adequate training or resources? That’s on the sponsor/CRO.
  
  

Both Edye and Darshan agree: most findings land in a gray zone. That’s why collaboration, transparency, and clear communication are key.

Want more of these insights? Let us know—we’ve got more hot topics on deck. 

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