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Innovative Insights: Legal Updates in Life Sciences | Fourth Quarter 2025
ISSUES AND UPDATES
Reshaping the U.S. Pharmaceutical Landscape with an "America First" Agenda
By Steve Forster and Melissa Mannion
The Trump administration's "America First" agenda is reshaping pricing, manufacturing, and regulation of the pharmaceutical landscape, with a reported central objective of lowering U.S. drug prices by promoting stronger domestic supply chains and employing more assertive federal oversight of both foreign and domestic drug production.
This collection of articles provides an overview of four developments driving that shift: Most Favored Nation drug pricing agreements; the onshoring of drug manufacturing and heightened FDA scrutiny of foreign and domestic facilities; the FDA Commissioner's National Priority Voucher program and its insurance coverage implications; and the rapidly evolving legal landscape of the 340B Drug Pricing Program.
Against this backdrop, companies, payers, providers, and policymakers will confront a rebalancing of incentives and risks that touch nearly every point in the drug lifecycle—from portfolio selection and clinical development pathways to sourcing decisions, quality controls, contracting strategy, and reimbursement.
Global Insights
For relevant perspectives on these topics from our Jones Day colleagues across the globe, click on the image below.
Most Favored Nation Drug Pricing and Manufacturer Agreements
Through executive orders to federal agencies and letters to pharmaceutical manufacturers, the Trump administration has demonstrated an intensive effort to swiftly implement Most Favored Nation ("MFN") drug pricing policies to align national prescription drug prices with the lowest prices paid for the same drugs in other developed nations. This article offers perspective on the administration's renewed attempts to implement MFN pricing, contextualizes current manufacturer MFN agreements with the administration, and highlights CMS's recent payment model, which is designed to extend MFN prices to state Medicaid programs.
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FDA's Support for Onshoring Drug Manufacturing and Increasing Oversight of Foreign Facilities
This year, the White House and the U.S. Food and Drug Administration ("FDA") have made a number of announcements aimed at bolstering domestic manufacturing, or onshoring, of drugs and biological products while tightening oversight of foreign facilities. Here we'll discuss key features of the onshoring efforts and provide practical advice for industry players as they face reduced application review time for certain drugs and biologics, reduced regulatory barriers to expanding manufacturing capacity in the United States, and increased FDA compliance and enforcement attention for both foreign and domestic manufacturing facilities.
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Commissioner's National Priority Voucher Program and Coverage Considerations
In June, FDA Commissioner Marty Makary launched the Commissioner's National Priority Voucher pilot program, which aims to accelerate FDA review for drug and biologic company applications supporting national interests from the typical 10- to 12-month review time down to one or two months. We'll outline the program's review procedures and implications while highlighting various concerns that the program has inspired across industry.
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The Current Legal Landscape of the 340B Drug Pricing Program
In this article, we discuss several critical aspects of the existing federal 340B Drug Pricing Program that continue to be challenged through litigation, including manufacturers' distribution restrictions on contract pharmacy arrangements, the Health Resources and Services Administration's enforcement authority, and federal preemption challenges to state legislative action. Further, we discuss recent additions to the rapidly developing 340B Program, including an administrative dispute resolution process and a voluntary 340B Rebate Model Pilot Program.
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Balancing Possibilities with Realities—Cyber and Privacy Legal Trends in Life Sciences
By Ryan Blaney and Mauricio Paez
As rapid technological innovation continues in the life sciences sector, companies face intensifying federal and state regulation and enforcement risk in cybersecurity, data privacy, and AI governance. Recent enforcement and litigation trends indicate expanded and new compliance and liability risks for entities handling health-related data.
Against this backdrop, life sciences companies face the challenge of harmonizing economic pressures with regulatory expectations and heightened enforcement risk to mitigate exposure and sustain responsible innovation.
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EXECUTIVE ORDERS AND POLICY UPDATES
In the fourth quarter of 2025, the Trump administration and federal agencies have continued to issue executive orders and other regulatory actions with significant potential impacts for the life sciences industry.
Read More >>
RELEVANT RESOURCES
FDA's Biosimilar Playbook: Merging Biosimilarity with Interchangeability
FDA Proposes to Remove Comparative Efficacy Studies to Accelerate Biosimilar Development
Japanese Government Considers Potential Improvements to Patent Linkage System for Generics
Federal Circuit Clarifies Limits on Patentability of Clinical Study Results-Based Applications
Italy Leads the Way in Shaping National AI Legislation Within the EU
California Enacts SB 53, Setting New Standards for Frontier AI Safety Disclosures
EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 123.
NEWSWORTHY
DOJ trial attorney Alisha Crovetto returns to Jones Day in Washington.
Corporate transactions partner David C. Lee joins Jones Day in Irvine.
Jones Day Lawyers and Practices Earn Top Rankings in Chambers UK 2026 (Band 1: Samantha Silver: Life Sciences: Product Liability; Product Liability: Mainly Defendant).
The Best Lawyers in Germany™ 2026 recognizes 55 Jones Day lawyers across 29 practice areas (Dr. Christian B. Fulda (MUN) ranked in Biotechnology Law and Life Sciences Practice; Pharmaceuticals Law).
Jones Day named "Law Firm of the Year" in Appellate Practice among 293 rankings in the 2026 edition of Best Law Firms® (Biotechnology and Life Sciences Practice ranked).
Jones Day's Jocelyn Yu and Nicholas Hodges named "Leaders of Influence in Law" by San Diego Business Journal (Jocelyn's highlight paragraph is all about her work in the Life Sciences space).
The Best Law Firms in France recognizes Jones Day in 36 practices across 58 rankings (Paris has a Tier 1 ranking in the category Biotechnology and Life Sciences Practice).
