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.
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 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.”
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.
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.
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 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%.”
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.
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.
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.
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:
Supply Chain Disruptions: Tariffs on imported pharmaceuticals could disrupt existing supply chains, leading to potential shortages and increased costs for healthcare providers and patients.
Regulatory Ambiguity: The executive order lacks detailed implementation plans, leaving stakeholders uncertain about how the policies will be enforced and their practical implications.
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.
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 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.
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.
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
CMS Makes An Impactful Change Regarding Biosimilars
Within its final calendar year 2025 Medicare Advantage and Part D final rule seen here, the Centers for Medicare and Medicaid Servces (CMS) is allowing Part D sponsors the ability to make midyear substitutions of biosimilars for their reference products on their formularies.
Within its final calendar year 2025 Medicare Advantage and Part D final rule seen here, the Centers for Medicare and Medicaid Servces (CMS) is allowing Part D sponsors the ability to make midyear substitutions of biosimilars for their reference products on their formularies.
Specifically:
All biosimilars may be substituted as formulary maintenance changes: Part D sponsors may treat formulary substitutions of all biosimilars for their reference products as “maintenance changes” that would not require explicit prior approval by CMS. This option has previously been available only for interchangeable biological products. Part D sponsors previously had to obtain explicit approval prior to substituting biosimilars other than interchangeable biological products, and these substitutions applied only to enrollees who began therapy after the effective date of the change — delaying enrollees’ access to cheaper options. Treating all biosimilar substitutions as maintenance changes means that midyear formulary substitutions of biosimilars for their reference products would apply to all enrollees (including those already taking the reference product prior to the effective date of the change) following a 30-day advance notice to affected enrollees.
New interchangeable biological products may be immediately substituted: We are finalizing additional flexibility for interchangeable biological products not on the market at the time that Part D sponsors submit their initial formulary for CMS approval. Part D sponsors meeting certain requirements have the additional option to immediately substitute a new interchangeable biological product for a reference product and provide notice of the change to affected enrollees after making such change.
Biosimilar policy continues to evolve. It’s important to be in the know to plan accordingly.
Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology.
If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.
Lanton Law Speaks With Pharmacy Times About Provider Status
Below is the description from Pharmacy Times about our discussion with them on pharmacy provider status. You can listen to the interview here.
Below is the description from Pharmacy Times about our discussion with them on pharmacy provider status. You can listen to the interview here.
In this episode of Pharmacy Focus: Policy Edition, we delve into the intricacies of provider status for pharmacists, including challenges that have hindered pharmacists from attaining this recognition, the recent legislative strides, and the far-reaching implications for the field. Our guest, Ron Lanton III, Esq from Lanton Law, lends his expertise to shed light on the financial impacts and effective advocacy strategies.
Key Topics
Unpacking the concept of provider status for pharmacists and its significance
Recent legislative advancements that have propelled the provider status movement forward
Implications of achieving provider status: expanded clinical roles, reimbursement opportunities, and patient care improvements
Financial considerations for pharmacists and the broader healthcare landscape
Strategies for effective advocacy to accelerate provider status adoption
New York Proposes New PBM Regulations
The New York State Department of Financial Services has proposed new rules surrounding pharmacy benefit managers (PBMs) that deal with establishing definitions; licensing; contracting with pharmacies; acquisition of PBMs; consumer protections and audit regulations regarding PBMs.
The New York State Department of Financial Services has proposed new rules surrounding pharmacy benefit managers (PBMs) that deal with establishing definitions; licensing; contracting with pharmacies; acquisition of PBMs; consumer protections and audit regulations regarding PBMs.
This rulemaking is one to monitor especially with the recent events from the 10th Circuit. We have written a recent blog post on this developments surrounding this decision.
Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Our pharmacy practice has been helping pharmacies nationwide with operational issues, mergers and acquisitions, regulatory inquiries, audits, licensure, employment issues and contracting. Our lobbying efforts help pharmacies nationwide achieve improved business climates through carefully crafted legislation as well as counseling clients on responding to relevant proposed rules.
If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.
Biden Administration Announces First Ten Drugs Selected for Medicare Price Negotiation
The Biden Administration has announced today that Medicare will be able to negotiate drug prices for the first time due to provisions within the Inflation Reduction Act.
The Biden Administration has announced today that Medicare will be able to negotiate drug prices for the first time due to provisions within the Inflation Reduction Act.
The first ten selected drugs for negotiation are Eliquis, Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, Imbruvica, Stelara and Fiasp.
The Administration stated that these drugs “accounted for $50,5 billion in total Part D gross covered prescription drug costs. The negotiations will occur in 2023 and 2024 and any negotiated prices will become effective beginning in 2026.
According to HHS press release read here, “In future years, CMS will select for negotiation up to 15 more drugs covered under Part D for 2027, up to 15 more drugs for 2028 (including drugs covered under Part B and Part D), and up to 20 more drugs for each year after that, as outlined in the Inflation Reduction Act.”
Lanton Law is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments in the healthcare and life science spaces. Contact us to learn about how either our legal or lobbying services can help you attain your goals.
Pharmacy Congressional Bills to Watch
Two pro-pharmacy bills continue to make their way through Congress.
Two pro-pharmacy bills continue to make their way through Congress.
S.1038 titled Drug Price Transparency in Medicaid Act of 2023 sponsored by Senator Welch (D-VT) requires pass-through pricing models, and prohibits spread-pricing, for payment arrangements with pharmacy benefit managers under Medicaid. The bill also extends funding for retail pharmacy surveys and requires additional information with respect to price concessions and survey participation to be made publicly available.
S2052 titled Protect Patient Access to Pharmacies Act proposes to enforce any willing pharmacy requirements and establish safeguards to ensure patient access to pharmacies in Medicare Part D.
Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Our pharmacy practice has been helping pharmacies nationwide with operational issues, mergers and acquisitions, regulatory inquiries, audits, licensure, employment issues and contracting. Our lobbying efforts help pharmacies nationwide achieve improved business climates through carefully crafted legislation as well as counseling clients on responding to relevant proposed rules.
If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.
More Drugmakers Sue Biden Administration Over Medicare Negotiation
Johnson and Johnson has filed a lawsuit in New Jersey federal district court, arguing that the new powers granted to Medicare to negotiate drug prices violates the First and Fifth Amendments of the U.S. Constitution. Medicare’s new power to negotiate comes from the recently enacted Inflation Reduction Act (IRA). Earlier suits by Merck, Bristol Myers Squibb, the U.S. Chamber of Commerce and PhRMA have made similar arguments.
Johnson and Johnson has filed a lawsuit in New Jersey federal district court, arguing that the new powers granted to Medicare to negotiate drug prices violate the First and Fifth Amendments of the U.S. Constitution. Medicare’s new power to negotiate comes from the recently enacted Inflation Reduction Act (IRA). Earlier suits by Merck, Bristol Myers Squibb, the U.S. Chamber of Commerce and PhRMA have made similar arguments.
As part of the new law, the Centers for Medicare and Medicaid Services (CMS) will publish a list of which drugs were selected for a first cycle of negotiations on Sept. 1, with prices taking effect in 2026. The companies that make those drugs face an October deadline to sign agreements to participate in those negotiations.
Lanton Law is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments in the healthcare and life science spaces. Contact us to learn about how either our legal or lobbying services can help you attain your goals.
Lanton Law Quoted in Pharmacy Times Article Titled "Mifepristone Has its Day in Court"
Lanton Law was quoted in Pharmacy Times article titled “Mifepristone Has its Day in Court.” The article discusses the drug amid its backdrop in the U.S. Supreme Court.
Lanton Law was quoted in Pharmacy Times article titled “Mifepristone Has its Day in Court.” The article discusses the drug amid its backdrop in the U.S. Supreme Court.
Lanton Law Lobbies on Beacon Hill in Boston, Massachusetts for Pharmacy Issues
Lanton Law was on Beacon Hill this week advocating for pharmacy issues.
Lanton Law was on Beacon Hill this week advocating for pharmacy issues. We are happy to be working with several pharmacy allies within the legislature on meaningful issues around health promotion screening and pharmacy benefit manager transparency.
Lanton Law Teams Up With MSHP on Health Promotion Screening Bill
On behalf of the Massachusetts Society of Health-System Pharmacists, we wrote an article advocating for the importance of health promotion screening in Massachusetts.
On behalf of the Massachusetts Society of Health-System Pharmacists, we wrote an article advocating for the importance of health promotion screening in Massachusetts. The Pharmacy Times article can be accessed here.
Lanton Law Speaks at Summit & Reverse Expo
We were pleased to be invited to Orlando, Florida to speak with IDN with our presentation titled “Price, Innovation & Policy: What’s on the Horizon for the Industry.
We were pleased to be invited to Orlando, Florida to speak with IDN with our presentation titled “Price, Innovation & Policy: What’s on the Horizon for the Industry.
Congressional Bill Advocating for Biosimilars and Generics Introduced
U.S. Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT) have introduced the Affordable Prescriptions for Patients Act. The bill seen here seeks to lower drug prices by preventing bad actors’ anti-competitive use of patents to block generic and biosimilar competition from coming to market. The bill addresses two important issues such as product hopping and the patent dance.
U.S. Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT) have introduced the Affordable Prescriptions for Patients Act. The bill seen here seeks to lower drug prices by preventing bad actors’ anti-competitive use of patents to block generic and biosimilar competition from coming to market. The bill addresses two important issues such as product hopping and the patent dance.
Product hopping: As far as product hopping, “the bill puts an end to this practice. It prohibits branded drug manufacturers from engaging in anticompetitive product hopping and facilitates entry to the market for generics and biosimilars, driving down drug costs.”
Patent dance: “This bill places a reasonable limit on the number of patents a manufacturer can contest, preventing a “patent thicket.” This will help deter branded manufacturers of biologics from gaming the system to increase the number of patents they assert, while preserving the incentives provided by the patent system to encourage the core innovation that produces new biologic treatments in the first place.”
Lanton Law is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments in the healthcare and life science spaces. Contact us to learn about how either our legal or lobbying services can help you attain your goals.