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.

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.

Understanding the 2025 Executive Order on Most-Favored-Nation Drug Pricing: Implications for Healthcare Stakeholders

On May 12, 2025, President Trump signed an executive order titled "Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients," aiming to align U.S. prescription drug prices with the lowest prices paid by other developed nations.

Key Provisions:

• Most-Favored-Nation (MFN) Pricing: The order mandates that Americans should not pay more for prescription drugs than patients in other developed countries. It directs the Secretary of Health and Human Services (HHS) to establish MFN price targets within 30 days and communicate these to pharmaceutical manufacturers.

• Direct-to-Consumer Sales: HHS is instructed to facilitate programs allowing pharmaceutical manufacturers to sell directly to American patients at MFN prices, potentially reducing reliance on intermediaries.

• Addressing International Pricing Disparities: The Secretary of Commerce and the U.S. Trade Representative are directed to take action against foreign practices that may contribute to higher drug prices in the U.S., ensuring that American patients do not disproportionately fund global pharmaceutical research and development.

Potential Impact:

While the executive order sets forth ambitious goals to reduce drug prices, its implementation may face challenges, including legal scrutiny and resistance from stakeholders concerned about its impact on innovation and global pricing dynamics. The effectiveness of the order will depend on the specifics of the forthcoming regulations and the responses from pharmaceutical companies and international partners.

Call to Action:

Healthcare providers, insurers, and pharmaceutical companies should closely monitor developments related to this executive order. For a comprehensive analysis of its implications and guidance on navigating the evolving regulatory landscape, contact Lanton Law today.

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.​

Executive Action Targets High Drug Costs: What the Industry Needs to Know

On April 15, 2025, President Trump signed the executive order titled “Lowering Drug Prices by Once Again Putting Americans First,” signaling a significant shift in U.S. pharmaceutical policy. This directive aims to reduce prescription drug costs through a multifaceted approach, impacting various aspects of the healthcare industry.​

Key Provisions:

• Medicare Drug Price Negotiation: The order directs the Department of Health and Human Services (HHS) to enhance the Medicare Drug Price Negotiation Program. This includes prioritizing high-cost drugs and improving transparency to achieve greater savings for beneficiaries.​

• Alignment of Payment Structures: It proposes aligning Medicare payments for certain prescription drugs with the actual acquisition costs incurred by hospitals, potentially lowering prices by up to 35%. Additionally, the order seeks to standardize payments for treatments like cancer therapies, regardless of the care setting, which could reduce costs by as much as 60%. 

• Discounted Medications for Low-Income Patients: The executive order reinstates programs to provide insulin and injectable epinephrine at significantly reduced prices for low-income individuals and the uninsured, aiming to make these life-saving medications more accessible.

• Facilitation of Drug Importation: It instructs the FDA to streamline the approval process for state-run drug importation programs, potentially allowing states to source medications from countries like Canada to reduce costs.

• Acceleration of Generic Drug Approvals: The order calls for the FDA to expedite the approval of generic and biosimilar drugs, fostering competition and potentially leading to lower drug prices.

Implications for the Healthcare Industry:

While the executive order outlines ambitious goals, the industry is looking for additional details. The potential for new tariffs on imported pharmaceuticals, coupled with changes in Medicare payment structures, could disrupt supply chains and affect pricing strategies. Healthcare providers, pharmaceutical companies, and policymakers must navigate these changes carefully to mitigate risks and capitalize on opportunities.​

How Lanton Strategies Can Assist:

In this evolving policy landscape, Lanton Strategies offers strategic consulting and lobbying services to help clients understand and influence the implications of the executive order. Our expertise in healthcare policy and regulatory affairs positions us to provide targeted messaging and advocacy efforts, ensuring our clients' interests are represented before the Administration and Congress. Contact us to learn more about how we can help you navigate this period of change.​

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.   

The UK’s AI Regulation Bill: A Strategic Reboot for Trust and Innovation

The reintroduction of the Artificial Intelligence (Regulation) Bill [HL] by Lord Holmes of Richmond in March 2025 seen here marks a pivotal moment in the UK’s AI legislative journey—one that reflects both a pragmatic reassessment of regulatory gaps and a desire to reestablish public trust in AI.

At its core, this Private Members’ Bill proposes the creation of a centralized AI Authority—a move that industry and legal experts alike recognize as long overdue. Unlike the government’s earlier “pro-innovation” strategy, which leaned heavily on voluntary commitments, Lord Holmes’ bill brings needed structure and enforceability. It’s a shift that positions the UK to balance innovation with ethical safeguards, much like efforts underway in the EU and U.S.

The bill highlights key regulatory pillars: safety, transparency, accountability, fairness, and contestability meant to govern the development, deployment, and monitoring of AI systems across sectors, from healthcare and finance to defense and education.

Two provisions in particular deserve emphasis. First, the requirement for designated AI officers within organizations introduces a tangible compliance mechanism—ensuring there’s real human oversight in algorithmic decision-making. Second, the inclusion of regulatory sandboxes is a clear nod to innovation, giving developers a safe and supervised space to test new technologies before widespread release.

Notably, the bill also calls for disclosure of training data and IP usage, a provision that resonates with concerns from creative and scientific communities around data provenance and rights protections. And perhaps most crucially for public trust, it mandates ongoing public engagement, anchoring AI governance in democratic accountability.

While the bill still faces the typical uphill climb of any Private Members’ Bill, it serves as a blueprint for a more balanced, enforceable approach to AI regulation in the UK. For legal practitioners, AI developers, and policymakers, this reintroduction is more than legislative housekeeping—it’s a strategic reset.

At Lanton Strategies, we believe that regulatory clarity is not a barrier to innovation—it’s the very foundation for sustainable growth in the AI era. Lanton Strategies is an international government affairs consulting firm that specializes in healthcare and technology. Contact us today to learn more about how we can help you.

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.

New Presidential Executive Order on Artificial Intelligence Released

According to the White House, the President has signed a January 23, 2025 Executive Order (EO) on artificial intelligence. According to the White House release the EO does the following: 

• This Executive Order establishes the commitment of the United States to sustain and enhance America’s dominance in AI to promote human flourishing, economic competitiveness, and national security.

• American development of AI systems must be free from ideological bias or engineered social agendas. With the right government policies, the United States can solidify its position as the leader in AI and secure a brighter future for all Americans.

• The order directs the development of an AI Action Plan to sustain and enhance America’s AI dominance, led by the Assistant to the President for Science & Technology, the White House AI & Crypto Czar, and the National Security Advisor

• It further directs the White House to revise and reissue OMB AI memoranda to departments and agencies on the Federal Government’s acquisition and governance of AI to ensure that harmful barriers to America’s AI leadership are eliminated.

  Lanton Law is a national boutiquelaw andgovernment affairs firm that closely monitors legislative, regulatory and legal developments in the healthcare and technology spaces.Contact us to learn about how either ourlegal orlobbying services can help you attain your goals.

Effects of the Federal Trade Commission's Repeal of Non-Compete Agreements on the Pharma Industry

In an interview with Associate Editor Donald Tracy, MA, Ron Lanton III, Esq., Partner, Lanton Law offers his thoughts on the recent Federal Trade Commission (FTC) repeal of non-compete agreements, and how it could effect the #pharma industry.

The interview can be viewedhere.