Ron Lanton Discusses 340B Compliance and Patient Access with Drug Topics

Lanton, Lanton & Sosa Law is pleased to share that Ron Lanton III, Esq., Senior Partner of the firm, was recently featured in Drug Topics in a discussion on the 340B Drug Pricing Program and its importance to pharmacists, safety-net providers, and the patients they serve.

The 340B Program remains one of the most important and complex areas in healthcare policy. For pharmacies, hospitals, covered entities, and other stakeholders, the program sits at the intersection of patient access, regulatory compliance, reimbursement pressure, and federal oversight.

In the Drug Topics discussion, Ron addressed how the 340B Program can serve as a critical infrastructure tool for safety-net providers, helping them stretch limited resources, support clinical services, and reach vulnerable patient populations. He also emphasized the importance of compliance readiness, program oversight, and understanding how evolving policy expectations may affect pharmacies and healthcare organizations.

At Lanton, Lanton & Sosa Law, our healthcare regulatory work focuses on helping clients understand complex policy environments before they become operational, compliance, or business risks. The 340B Program is a clear example of how legal, regulatory, and market issues often move together.

You can read the full Drug Topics FAQ here.

Buying or Selling a Healthcare Practice Is Not Just a Regular Business Transaction

Buying or selling a healthcare practice can look simple from the outside. There is a buyer, a seller, a purchase price, and a set of documents that need to be signed. In healthcare, it is rarely that simple.

A medical practice, pharmacy, therapy practice, dental office, med spa, or other healthcare business is not just a collection of patients, equipment, contracts, leases, and revenue. It operates inside a regulated environment. That means the transaction has to account for issues that do not always show up in a basic business sale.

Licensure, payer contracts, patient records all matter. Employee obligations, referral relationships, corporate structure, privacy rules, billing history, and compliance risk matter too. Any one of those issues can affect the value of the practice and the ability of the buyer to keep the business operating after closing.

That is where many healthcare transactions become more complicated than expected.

A buyer may believe they are purchasing a stable book of business, only to find out that certain payer contracts cannot be assigned. A seller may assume the transition will be straightforward, only to discover that licensing timelines, lease restrictions, or patient notice requirements slow the deal down. A lender or investor may focus on revenue, while missing the regulatory issues that make that revenue harder to preserve.

The structure of the deal matters too.

An asset purchase and an equity purchase can create very different legal and operational consequences. The parties need to know whether professional licenses are changing, whether the seller will stay involved after closing, whether key employees need new agreements, whether the lease can be assigned, and whether the buyer can continue billing under the same contracts.

These are not issues to save for the end of the transaction. They should be part of the conversation before the parties get too far down the road on price, timing, and closing expectations.

For sellers, preparation can make the deal much cleaner. Corporate records, contracts, employment files, compliance policies, leases, payer documentation, and licensing materials should be reviewed before a buyer starts asking for them. A practice that is organized is easier to value, easier to diligence, and easier to transfer.

For buyers, diligence is not just about confirming revenue. It is about understanding whether that revenue can continue after closing. That requires looking at the business through a healthcare regulatory lens, not only a financial one.

The best healthcare transactions are planned before they are negotiated. In a regulated market, the legal structure of the deal can be just as important as the business opportunity behind it.

AI Medical Advice Is Moving Faster Than Healthcare Risk Management

Artificial intelligence is quickly becoming part of the healthcare experience. Patients are using AI tools to ask questions, interpret symptoms, manage medications, and decide whether they need to seek care. Some of these tools are being introduced through formal healthcare partnerships. Others are consumer-facing platforms that were never designed to operate as part of the healthcare system.

The problem is that patients are not always seeing the difference between a tool that gives general information and a tool that sounds like it is giving medical guidance. This is where real risks comes in.

The recent lawsuit in Pennsylvania involving Character.AI is a reminder that healthcare risk is no longer limited to hospitals, physicians, pharmacies, or traditional medical technology companies. When patients rely on AI-generated information to make decisions about their health, the legal and regulatory questions become much more complicated.

Who is responsible if the information is wrong? Was the platform providing general information, or did it cross into something closer to medical advice? Did the user understand the limits of the tool? Was there any process for escalation, disclosure, clinical review, or human oversight?

These questions matter because AI is not entering healthcare through one clean channel. It is coming through consumer applications, state partnerships, provider workflows, payer systems, pharmacy tools, and patient-facing platforms. Some uses may be administrative. Others may influence clinical decision-making in ways that are not obvious at the beginning.

That creates a different kind of risk environment for healthcare organizations.

The issue is not whether AI should be used in healthcare. It will be used and increasingly so. The more important question is whether healthcare organizations have the governance structure to understand how it is being used, who is relying on it, and where the legal risk sits.

For providers, pharmacies, health systems, digital health companies, and other healthcare organizations, AI review cannot sit only with the technology team. It needs to involve legal, compliance, clinical, operational, and risk management leadership before the tool is placed in front of patients or built into a workflow.

That review should start with practical questions. What is the tool actually doing? Is it generating general information, making recommendations, triaging care, renewing medications, or influencing a provider’s decision? Who reviews the output? What disclosures are being made to patients? How are errors identified? What happens when the AI reaches the limit of what it should answer?

The answers to those questions may determine whether an organization is using AI as a helpful support tool or unintentionally creating a new source of professional, regulatory, and operational exposure.

Healthcare has always depended on trust. AI does not remove that obligation. It simply changes where the trust is being placed.

As AI becomes more visible in healthcare, the organizations that move carefully will not be the ones avoiding innovation. They will be the ones that understand that innovation needs structure around it.

NYSBA Program: Policy, Pricing, and Market Strategy

On May 15, 2026, at 12:00 PM ET, I will be speaking as part of the New York State Bar Association Food, Drug & Cosmetic Law Section program, “Policy, Pricing, and Market Strategy.”

Healthcare organizations are increasingly operating in an environment where policy decisions directly influence pricing strategy, reimbursement planning, commercialization, and long term market positioning. Drug pricing reform, trade pressures, supply chain risk, and evolving regulatory frameworks are no longer isolated legal issues. They are becoming central business considerations across the healthcare and life sciences industries.

I look forward to joining the discussion with colleagues from across the healthcare and legal sectors.

When AI Starts Practicing Medicine Without a License

A recent lawsuit filed by the Commonwealth of Pennsylvania against Character.AI may become one of the first major legal tests of how existing healthcare laws apply to artificial intelligence systems that interact directly with the public. According to the complaint, a chatbot allegedly represented itself as a licensed psychiatrist, claimed to hold a Pennsylvania medical license, discussed mental health symptoms with users, and suggested it could prescribe medication.

For healthcare organizations and employers experimenting with AI tools, the significance of this case extends well beyond one platform.

AI systems are increasingly moving from administrative assistance into spaces traditionally occupied by licensed professionals. Once that happens, organizations begin facing questions involving liability, supervision, disclosure obligations, documentation standards, and professional licensing restrictions.

Many healthcare systems are already integrating AI into scheduling, intake, documentation, patient communications, and behavioral health support. The line between “informational assistance” and “clinical guidance” can become blurred very quickly when conversational AI systems are designed to appear human and authoritative.

One of the more important signals from the Pennsylvania lawsuit is that regulators appear focused less on disclaimers and more on how users could reasonably interpret the interaction itself. That has implications far beyond chatbot companies.

The larger takeaway from the Pennsylvania lawsuit is that AI governance may develop through existing regulatory and licensing structures long before comprehensive federal AI legislation arrives.

For organizations deploying AI tools in healthcare and other high trust environments, the question is becoming less about whether AI can be used and more about how it is supervised, governed, and operationally controlled.

Ron Lanton Featured in Reuters on Global Drug Pricing and Market Strategy

Recent coverage in Reuters highlights how U.S. pricing policy is beginning to influence global launch strategy for pharmaceutical companies.

The article examines how manufacturers are adjusting decisions across markets in response to policy pressure and evolving reimbursement dynamics. Click here to view the article.

Mergers and Acquisitions Are Not About the Deal

Most M&A conversations begin with momentum. A buyer is interested, a seller is ready, the valuation makes sense, and the timeline is moving. From the outside, it looks like progress. What is actually happening is a change in direction. There is a moment in these deals that does not get enough attention, when everything still looks clean on paper. Then one question shifts the conversation. What actually changes the day after this closes? Not in theory, in practice. Contracts start to behave differently under new ownership. Revenue that felt stable begins to depend on relationships that may not carry over the way everyone expected. Regulatory exposure shows up in places that were easy to overlook when everything was still in a data room.

That is usually where the pace slows, not because the deal is wrong, but because something important has not been fully seen yet. Most deals close. Fewer hold together the way they were expected to. The issues tend to surface later, when a contract does not perform the way it was assumed or when a regulatory requirement becomes operational instead of theoretical. By then, the deal is already done and the room to adjust is smaller.

The work I focus on now starts earlier. It begins with understanding how the business actually functions before the deal takes shape, where revenue is coming from, how it is protected, and where the pressure points are. That perspective changes the outcome. The deal becomes something the business can actually operate inside of after it is done. Mergers and acquisitions are inflection points where capital, regulation, and operations all meet at once. When those elements are aligned, the business moves forward with clarity. When they are not, the friction shows up over time.

Most businesses do not need more deal activity. They need a clearer view of what happens after they move. That conversation usually starts earlier than people expect.

Ron Lanton Discusses FDA’s Single-Trial Approval Pathway with Pharmaceutical Executive

Ron Lanton spoke with Pharmaceutical Executive about the FDA’s evolving approach to drug approvals and the potential shift toward a single-trial evidentiary pathway. The discussion examines how changes in regulatory expectations could affect development strategy, litigation exposure, and pricing dynamics across the pharmaceutical sector. As regulatory signals increasingly influence market strategy, companies developing innovative therapies must evaluate not only the scientific strength of their programs but also how evolving FDA policy may shape investor expectations and commercialization timelines. Listen to the interview here.

Ron Lanton Discusses Moderna mRNA Regulatory Uncertainty with Pharmaceutical Executive

Ron Lanton spoke with Pharmaceutical Executive about regulatory uncertainty surrounding Moderna’s mRNA influenza vaccine review and what it could signal for the broader biotechnology sector. The discussion focused on how shifts in regulatory signals can influence market confidence in platform technologies such as mRNA and whether those signals could affect the development strategies of other manufacturers. Listen to the discussion here.

In Pharmaceutical Executive: Ron Lanton on the FDA’s Changing Clinical Trial Framework

he FDA recently signaled a shift away from the long-standing expectation that new drugs demonstrate effectiveness through two pivotal trials.

The agency’s updated approach to clinical trial evidence could have implications for sponsors navigating regulatory approval pathways.

In this brief update, Ron Lanton walks through what the FDA announced and how the agency is thinking about trial requirements moving forward.

@Pharmaceutical Executive

https://www.pharmexec.com/shorts/fda-drops-two-trial-rule-new-drugs

Healthcare policy conversations are starting to converge

PBM reform.
Break Up Big Medicine proposals.
Pricing codification efforts.

Individually, each looks like a discrete initiative.

Collectively, they signal something more important.

To me, this is a gradual rebalancing of leverage across the healthcare distribution system.

For the last decade, consolidation and rebate architecture concentrated negotiating power in predictable places. That structure created efficiencies for some — and real pressure for others.

Now we’re seeing policy threads that, taken together, may begin shifting contracting incentives, rebate dynamics, and pricing assumptions over the next 12–24 months.

This isn’t about one bill or one reform.

It’s about incentives.

When leverage shifts, distribution strategy shifts.

When distribution shifts, pricing architecture adjusts.

The leaders who think structurally aren’t reacting to headlines; they’re stress-testing their assumptions.

Remember — don’t chase the headlines.

The Consolidated Appropriations Act of 2026 is a reminder that legal risk rarely shows up all at once.

Large, omnibus legislation like the CAA doesn’t usually create immediate problems through a single provision. The risk tends to emerge later—when new funding conditions, program clarifications, and agency guidance collide with existing operations, contracts, and compliance assumptions.

For healthcare and regulated organizations, the real question is not simply what changed, but whether decisions that were reasonable six months ago are still defensible today.

That’s where ongoing general counsel support adds value. The organizations that navigate legislative change most effectively are the ones reviewing contracts, compliance posture, and operational decisions early—before audits, counterparties, or regulators force the issue.

Major legislation doesn’t create most legal problems. It reveals the ones that were already forming.

The organizations that fare best are the ones treating moments like this not as compliance exercises, but as opportunities to pressure-test decisions before they’re tested for them.

A New Chapter: Lanton Law is now Lanton, Lanton & Sosa Law

By: The Partners of Lanton, Lanton & Sosa

We are thrilled to share some major news with our clients, colleagues, and friends.

If you’ve visited our website today or seen our recent press release, you likely noticed a change. Lanton Law, PLLC has officially rebranded to Lanton, Lanton & Sosa Law, PLLC.

This isn’t just a name change—it’s a reflection of how we are evolving to meet your needs. Over the past few years, our clients have asked for more support in complex areas like real estate, technology, and corporate growth. We listened, and today we are expanding our team and our practice to deliver exactly that.

Meet Our New Managing Partner

The "Sosa" in our new name belongs to Maria Sosa, whom we are honored to welcome as our new Managing Partner.

Maria is not just joining the leadership team; she is bringing an entirely new capability to the firm: Commercial Real Estate. Whether you are navigating property development or complex transactions, Maria’s expertise adds a critical pillar to the services we offer. She will also be heavily involved with our healthcare and technology clients, as well as with Lanton Strategies International. There she will be driving advocacy for our clients across the Northeast.

Expanded Services for a Changing World

Alongside this rebrand, our existing leadership is taking on new strategic roles to broaden our scope:

• Ron Lanton is now Senior Partner and Global Strategist. While he remains the dedicated General Counsel for our healthcare and life sciences clients, he is formally expanding his practice to include Mergers and Acquisitions (M&A). If your company is looking to grow, acquire, or exit, Ron is ready to guide that strategy.

• Casandra Lanton has been appointed Chief Legal Officer. She is expanding her expertise beyond Human Resources and Employment Law to include Technology Law, ensuring your business is protected in an increasingly digital and regulated environment.

Bridging D.C. and New England

We know that policy decisions made in Washington often have ripple effects on business operations in the Northeast. That is why we are solidifying our footprint.

• Headquarters: We remain rooted in Washington, D.C., at the center of legislative and regulatory affairs.

• Principal Operations: We have established a major operational hub in Boston, Massachusetts, allowing us to serve our New England clients more directly.

What This Means for You

If you are a current client, the only thing changing is our letterhead. You will continue to receive the same personalized, high-level counsel you rely on—now with even more resources at your disposal.

Thank you for trusting us with your business. We are excited to step into this future with you.

— The Team at Lanton, Lanton & Sosa Law, PLLC

Read the full official press release here.

Lanton Law Speaks with Drug Topics on Its Over the Counter Podcast on MFN

Ron Lanton of Lanton Law speaks with Drug Topics on their podcast episode of Over the Counter. Ron discusses developing policy expected to enact significant change in the pharmacy industry and beyond titled “Most Favored Nation: Global Benchmarking to Reimagine US Drug Distribution.” Click here to access the podcast.

Unpacking the Framework: Inside the US-UK Tech Prosperity Deal

While the recent suspension of the US-UK "Tech Prosperity Deal" has dominated the headlines, smart stakeholders know that to navigate the future, you must understand the blueprint. Signed during President Trump’s state visit to the UK in September 2025, this agreement was designed to be a "generational step-change" in the transatlantic special relationship.

Based on the Memorandum of Understanding and the US Embassy’s summary, here are the three core pillars of the deal that every tech and energy leader needs to know.

1. Artificial Intelligence: Aligning Standards & Science

The deal focuses heavily on regulatory alignment to prevent a fragmented AI market.

• Standards & Safety: It establishes a direct partnership between the U.S. Center for AI Standards and Innovation (CAISI) and the UK AI Security Institute (AISI) to harmonize model testing and risk management.

• AI for Science: A flagship program was created to link U.S. agencies (DOE, HHS, NSF) with UK counterparts to accelerate biotechnology breakthroughs, specifically in cancer research and precision medicine.

2. Civil Nuclear Energy: Cutting Red Tape & Russian Dependence

For the energy sector, the deal proposes a radical streamlining of regulatory hurdles.

• Faster Licensing: The agreement targets a timeline of just two years for reactor design reviews and one year for site licensing by aligning the U.S. Nuclear Regulatory Commission and UK Office for Nuclear Regulation.

• Energy Security: It commits the UK to full independence from Russian nuclear fuel by 2028, ensuring a secure, allied supply chain.

3. Quantum Computing: The Race for Standards

Recognizing that Quantum is the next frontier, the deal emphasizes interoperability. It creates a joint benchmarking task force to set shared standards for hardware and algorithms, ensuring that U.S. and UK quantum ecosystems can grow together rather than as competitors.

The "Operative" Clause

Crucially, the MOU includes a provision that the deal only becomes "operative" alongside progress on the broader Economic Prosperity Deal. This legal nuance is exactly why the current trade disputes have halted implementation—a reminder that in international agreements, the fine print always matters.

Call to Action Whether this deal is revived or renegotiated, the regulatory intent of both nations is clear. If your organization operates in AI, nuclear energy, or quantum computing, you need a strategy that anticipates these converging standards. Contact Lanton Strategies today to position your business for the future of transatlantic tech policy.

Policy Alert: What the £31bn Tech Deal Suspension Means for US and UK Innovation

With the Trump administration’s sudden suspension of the £31bn "Tech Prosperity Deal," the future of transatlantic innovation faces immediate and critical uncertainty. As reported, this landmark agreement—intended to bolster cooperation in AI, quantum computing, and civil nuclear energy—has been paused due to frustrations over non-tariff trade barriers and digital services taxes.

This development highlights the volatility of international trade agreements and the transactional nature of the current regulatory environment. To understand the full scope of the cooperation and specific provisions that are now at risk, I encourage stakeholders to review the details of the of the Memorandum of Understanding regarding the “Tech Prosperity Deal” click here.

The suspension places pledged investment from major tech players on ice and creates significant headwinds for innovation hubs in both nations. For stakeholders, this is a stark reminder that policy and prosperity are inextricably linked.

At Lanton Law and Lanton Strategies, we specialize in helping Transatlantic organizations navigate these complex government affairs and legal challenges. When the geopolitical landscape shifts, your strategy must adapt immediately.

Don't let diplomatic friction stall your innovation pipeline. Contact us today for strategic consulting on how this suspension impacts your business. Let’s discuss how we can help you pivot and thrive despite these headwinds.

New Trans-Atlantic Drug Pricing Deal: What Supply Chain Stakeholders Must Know

In a major development for the global life-sciences landscape, the United States and the United Kingdom have reached an agreement in principle that reshapes how both countries approach pharmaceutical pricing and cross-border trade.

Under the agreement, the U.K. will raise the net price of new medicines by 25%, reversing years of downward pressure that had strained returns on innovative therapies. The government will also ease the financial burden of its VPAG rebate structure, capping repayment levels and committing to maintain rebate rates at or below approximately 15% starting in 2026. These changes reflect a broader acknowledgment that sustaining innovation requires restoring reasonable margins across the branded pharmaceutical marketplace.

In exchange, the United States will exempt U.K.-origin pharmaceuticals, active ingredients, and medical technologies from current and prospective Section 232 tariffs. This concession reduces supply-chain volatility and removes a major source of uncertainty for U.S. companies sourcing components or finished products from the U.K. It also signals a more cooperative posture between two major life-sciences hubs as they seek to reinforce global competitiveness.

For 2026, this agreement provides both opportunity and complexity. Companies should monitor how implementation unfolds and assess how pricing, market access, and supply-chain exposure may shift.

If you are a pharmaceutical supply-chain stakeholder seeking help assessing potential risks or developing a 2026 strategy, contact Lanton Strategies today. Our team can guide you through the policy, regulatory, and market implications of this evolving landscape.

Lanton Law Returns to Moderate Most Favored Nation Panel for Pharmacy Times

Lanton Law retuned to moderate the third and final panel on MFN for Pharmacy Times titled “How Trump Is Disrupting Pharma: Exploring the Impacts of MFN, Tariffs and DTC on Drug Markets.” The panel discussion can be heard here.

Lanton Law Quoted in Bloomberg Law

We have been talking a lot lately about drug pricing; specifically Most Favored Nation (MFN) and other ancillary issues. We were recently quoted in Bloomberg Law News on the issue here. Thanks to Nyah Phengsitthy for reaching out.

Lanton Law Moderates Most Favored Nation Panel for MJH Life Sciences

Lanton Law was honored to be selected as a moderator for the MJH Life Sciences panel titled ““Most Favored Nation Order: Legal Battles, Market Shifts, and the Future of Drug Pricing Reform.”

The AJMC wrote a nice blog post on the panel. The panelists, included moderator Ron Lanton, JD, of Lanton Law; Mel Whittington, PhD, managing director and head of the Leerink Center for Pharmacoeconomics at MEDACorp, Inc.; Stephen Forster, JD, partner at the Health Care and Life Sciences Practice at Jones Day; and Peter Rubin, executive director of No Patient Left Behind. The panel discussed the voluntary Pfizer agreement, which aims to reduce prices by up to 85%, and the new TrumpRx platform, set to launch in 2026 to allow direct-to-consumer medication purchases.

The Pharmaceutical Executive story on the panel can be found here.

The AJMC article on the panel can be viewed here.