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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Medical communications teams must exercise caution when using websites dedicated to medical affairs, as legal risks go beyond overt sales promotion. Drug and device manufacturers face compliance challenges, particularly when these platforms are accessed by broader audiences, including non-scientists.

Key risks include:

• Off-Label Promotion: The Facteau case highlights how communications implying off-label use can lead to violations under the Food, Drug, and Cosmetic Act, even for FDA-cleared devices.
• Improper Audience Targeting: Specialized medical affairs websites are intended for healthcare professionals. If content inadvertently targets patients or the general public, it may be deemed promotional, violating FDA rules.

To mitigate risks, companies should:

1. Clearly define intended use and avoid statements endorsing unapproved applications.
2. Consider separate patient engagement pages to keep medical affairs content professional and compliant.
3. Regularly review communication strategies in light of evolving guidance, such as the CFL and SIUU Guidance, and recent legal decisions like Loper Bright.

The $3 billion GSK settlement underscores the stakes—misbranding, off-label promotion, and audience misalignment can result in severe penalties and reputational harm. Manufacturers should seek expert legal counsel, like the Kulkarni Law Firm, to ensure compliance and safeguard against regulatory risks.

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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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