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.

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.

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.

Bipartisan Bill Aimed At Expanding CMS Coverage Of Rx Digital Therapeutics Re-Introduced

The Access to Prescription Digital Therapeutics Act of 2025 (S1702/3288) seen here has been re-introduced by Senators Shelley Moore Capito (R-WV) and Jeanne Shaheen (D-NH)) and Representatives Kevin Hern (R-OK) and Mike Thompson (D-CA). The proposed legislation would do the following: 

• Create a reimbursement pathway for software that treats medical conditions

• Create a new Medicare benefit category for Food and Drug Administration (FDA)-cleared prescription digital therapeutics to be prescribed to seniors in the program.

• Require the CMS to develop payment methodologies for prescription digital therapeutics and create product-specific CPT codes to adequately reimburse for the products. 

Lanton Law through its Government Affairs Division Lanton Strategies has been following digital therapeutic policy as it unfolds. This is an oftentimes confusing area of policy since it is innovative and many times mistakenly tied to FDA approvals. 

Stakeholders who are interested in this issue and want to ensure compliance should ensure that an adequate and appropriate FDA approval and CMS reimbursement strategy is in place internally to avoid marketplace delays. Contact us to learn more.  

Lanton Law Interviewed by Pharmacy Times Over Prescription Drug Price Executive Order

Lanton Law was quoted in Pharmacy Times’ article titled “President Trump Signs Executive Order Aiming to Lower Prescription Drug Costs by Up to 90%.” The article can be accessed here.

New Federal Directives to Enhance U.S. Drug Manufacturing: Compliance Insights for Healthcare

On May 5, 2025, President Donald Trump signed the Executive Order on Regulatory Relief to Promote Domestic Production of Critical Medicines, marking a significant move to reduce America's reliance on foreign pharmaceutical manufacturing. This initiative aims to streamline regulatory processes, making it more feasible for domestic facilities to produce essential medicines.

Key directives include:

• FDA Regulatory Streamlining: The Food and Drug Administration (FDA) is tasked with reviewing and eliminating redundant regulations within 180 days to expedite the approval of domestic pharmaceutical manufacturing facilities.

• Enhanced Oversight of Foreign Producers: The FDA will increase inspections of overseas facilities to ensure they meet U.S. standards, aiming to level the playing field for domestic manufacturers.

• Accelerated Facility Construction: The Environmental Protection Agency is directed to expedite the permitting process for building pharmaceutical manufacturing plants in the U.S., addressing the current 5 to 10-year timeline deemed unacceptable for national security.

This executive order underscores a strategic pivot towards bolstering national security through domestic production of critical medicines. Healthcare organizations involved in pharmaceutical manufacturing, supply chain management, or regulatory compliance must assess their operations in light of these changes.

At Lanton Law, we specialize in guiding healthcare businesses through complex regulatory landscapes. Our expertise ensures your organization remains compliant and competitive. To understand how this executive order impacts your operations and to develop a proactive compliance strategy, contact us today.

Healthcare Compliance Alert: Navigating the New Biological Research Safety Mandates

On May 5, 2025, President Donald Trump signed the Executive Order on Improving the Safety and Security of Biological Research, marking a pivotal shift in U.S. biosecurity policy. This directive halts federal funding for "dangerous gain-of-function" (GoF) research, particularly in countries like China and Iran, where oversight is deemed insufficient. The move responds to concerns that such research—enhancing pathogens' transmissibility or virulence—could lead to lab accidents with catastrophic consequences, as speculated in the origins of COVID-19.

The order mandates the Office of Science and Technology Policy (OSTP) to collaborate with federal agencies to:

• Cease funding for high-risk GoF research abroad.

• Suspend ongoing domestic projects involving dangerous pathogens.

• Develop a comprehensive oversight framework within 120 days.

• Implement stringent compliance clauses in federal research contracts.

Healthcare entities engaged in biomedical research must now navigate a complex regulatory landscape. Compliance isn't optional; it's imperative. Institutions must audit current projects, reassess collaborations, and ensure alignment with the forthcoming policies.

At Lanton Law, we specialize in guiding healthcare organizations through regulatory transformations. Our expertise ensures that your research initiatives remain compliant and ethically sound. To understand how this executive order impacts your operations and to develop a proactive compliance strategy, contact us today.

Trump’s Pharmaceutical Tariffs: A New Operating Era for Healthcare

The Trump administration's recent trade and healthcare policies are poised to introduce significant uncertainty into the U.S. healthcare industry. Two pivotal executive actions—the initiation of a Section 232 national security investigation into pharmaceutical imports and the signing of the executive order titled “Lowering Drug Prices by Once Again Putting Americans First”—highlight the administration's approach.​

On April 1, 2025, the Department of Commerce commenced a Section 232 investigation to assess the national security implications of importing pharmaceuticals and their ingredients. This encompasses finished drug products, active pharmaceutical ingredients (APIs), and key starting materials. The investigation aims to determine whether reliance on foreign sources compromises national security, potentially leading to the imposition of tariffs ranging from 10% to 25% on these imports.

Simultaneously, President Trump signed the executive order “Lowering Drug Prices by Once Again Putting Americans First” on April 15, 2025. This order seeks to reduce prescription drug costs by enhancing Medicare drug price negotiations, reinstating discounted insulin programs, and increasing transparency in hospital drug acquisition costs.

While these measures aim to bolster domestic manufacturing and reduce drug prices, they introduce several uncertainties:​

1. Supply Chain Disruptions: Tariffs on imported pharmaceuticals could disrupt existing supply chains, leading to potential shortages and increased costs for healthcare providers and patients.​

2. Regulatory Ambiguity: The executive order lacks detailed implementation plans, leaving stakeholders uncertain about how the policies will be enforced and their practical implications.

3. Market Volatility: The potential for tariffs and changes in drug pricing regulations may lead to market instability, affecting investment decisions within the pharmaceutical industry.​

In this evolving landscape, healthcare entities must navigate the complexities of new trade policies and regulatory reforms. Lanton Law offers expertise in crafting targeted messaging and engaging with policymakers to advocate for client interests. Our team is equipped to assist clients in understanding and responding to these changes effectively. Contact us to learn more.​

Section 232 Targets Drug Imports: What It Means for Pharma and Healthcare

​On April 1, 2025, the U.S. Department of Commerce initiated a Section 232 national security investigation into the importation of pharmaceuticals and pharmaceutical ingredients. This inquiry aims to assess whether the reliance on foreign sources for essential medical products poses a threat to national security. The scope includes finished drug products, active pharmaceutical ingredients (APIs), key starting materials, and related derivatives.​

The Department of Commerce is soliciting public comments to inform this investigation. Stakeholders are encouraged to provide input on various factors, including:​

• The current and projected demand for pharmaceuticals and their ingredients in the U.S.​

• The capacity of domestic production to meet this demand.​

• The role and risks associated with foreign supply chains.​

• The impact of foreign government subsidies and trade practices on U.S. industry competitiveness.​

• The feasibility of expanding domestic manufacturing to reduce import reliance.​

Comments must be submitted by May 7, 2025, through the Federal Rulemaking Portal at www.regulations.gov, referencing Docket ID BIS-2025-0022. Submissions containing business confidential information should be clearly marked and accompanied by a non-confidential version.​

For further details, please refer to the official notice in the Federal Register: Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients.​

There are plenty of questions and speculation about what this means for specific supply chain participants. Contact Lanton Strategies to learn about how we can help you respond to these comments as well as help you speak with either Congress or the Administration to get your voice heard.   

Lanton Law Speaks with Pharmaceutical Executive on Navigating NIH Funding Cuts, Diversity Bans, and Tariff Challenges

Lanton Law spoke with Pharmaceutical Executive on NIH Funding cuts. The interview is titled “Navigating NIH Funding Cuts, Diversity Bans, and Tariff Challenges: Legal and Industry Implications for Medical Research”

The interview can be seen here.

Lanton Law Quoted in Pharmacy Times Interview on Drug Pricing Reforms Amid the Repeal of Executive Order 14087

Lanton Law was quoted in the Pharmacy Times Article titled "Reversal of Executive Order (EO) 14087 Raises Questions About Future Drug Pricing Reforms.” We discuss the EO and how pharmacists are impacted. The article can be viewed here.

FTC, DOJ and HHS Extend RFI on Private Equity Control in Health Care Markets

The Federal Trade Commission, the Department of Justice’s (DOJ) Antitrust Division, and the U.S. Department of Health and Human Services (HHS) are extending the deadline by 30 days for the public to comment on a tri-agency Request for Information (RFI) examining private-equity and other corporations’ increasing control over health care markets. The new deadline is now June 5, 2024.

At Lanton Law not only do we understand the issues, but we provide you with timely solutions to help you make informed decisions about either an acquisition target or ways to maximize value. We counsel clients by performing corporate due diligence, provide strategic advice for growth and business strategies as well as structuring and executing M&A transactions.

Contact us today to learn more