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.

Can America's Retreat On mRNA Be Europe's Opportunity?

Lanton Law has an article in Life Science Connect’s Advancing RNA titled “Can America's Retreat On mRNA Be Europe's Opportunity?”

With the unprecedented success of mRNA vaccines during the pandemic, it almost felt as though mRNA technology was about to enter a “golden era” where new solutions using this platform would be found to finally address costly and devastating diseases that had been wreaking havoc in many countries. Unfortunately, the steadfast rising skepticism in the U.S. about vaccines has caused a drastic change on mRNA from the U.S. Department of Health and Human Services (HHS).

To view the article click here.

Lawsuits Likely as Federal Authorities Roll Back Longstanding Vaccine Guidelines

In a recent interview with Pharmaceutical Executive, Ron Lanton, partner, Lanton Law, discussed the unprecedented legal and policy challenges emerging from recent changes to federal vaccine recommendations. The interview can be seen here.

Lanton Law Speaks on Clinical Ops Teams Maintaining Clinical Trial Integrity

Lanton Law spoke with Applied Clinical Trials on why evolving federal guidance and new technologies are pushing clinical operations teams to strengthen oversight and safeguard the credibility of clinical research.

The interview can be found here.

FDA FY 2026 Biosimilar Plan: Key Insights for Manufacturers and Investors

The FDA’s FY 2026 Legislative Proposal reaffirms its strong support for biosimilars as a key means to reduce drug costs and enhance competition. Building on its Biosimilars Action Plan, the Agency emphasizes streamlined approval pathways, enhanced interchangeability guidance, and policies aimed at overcoming scientific and manufacturing complexity. The FDA also signals that future resources will focus on advancing analytical tools and regulatory science to boost biosimilar adoption while safeguarding quality, safety, and efficacy.

Notably, the FDA underscores the importance of transparency and predictability—pillars of the Agency’s renewed commitment. This means clearer timelines, more robust FDA‑industry dialogue, and continued investment in research infrastructure to facilitate complex biologic comparisons. The proposal signals readiness to refine naming conventions, labeling standards, and post‑market surveillance to help manufacturers navigate biosimilar development while also ensuring clinician and patient confidence.

In short, the FDA is actively shaping an ecosystem that supports biosimilar innovation—with an eye on reducing health care spending and expanding patient access—while maintaining rigorous safety standards.

Navigating the evolving FDA landscape requires expert guidance. At Lanton Law, we help biosimilar manufacturers and partners strategize around regulatory hurdles, streamline business planning, and align submissions with FDA expectations. If you’re currently preparing for 2026 changes—especially concerning interchangeability, analytics, naming or the like—reach out to Lanton Law today for proactive, tailored counseling to position your biosimilar programs for success.

Rising API Tariffs Are Forcing Pharma to Shift R&D Resources

In Part 3 of our interview; Lanton Law speaks with Applied Clinical Trials on the highlights of how tariffs on active pharmaceutical ingredients could affect resources for maintaining and accelerating R&D pipelines. The interview can be heard here.

Lanton Law Talks to Applied Clinical Trials About How FDA Cuts Are Creating New Bottlenecks in Clinical Operations

In Part 2 of the interview; Ron Lanton, partner, Lanton Law, talks FDA layoffs and their impact on inspections and clinical trial timelines. The interview can be seen here.

Lanton Law Talks to Applied Clinical Trials About The Hidden Impact of Drug Pricing on Government Clinical Trials

In part one of this video interview, Ron Lanton III, Esq., partner, Lanton Law, discusses how a potential increase in drug costs could affect the clinical research industry. The interview can be seen here.