Insights

Since the signing of Executive Order 14187 (“Protecting Children from Chemical & Surgical Mutilation”) in late January 2025, the Trump Administration has made its skeptical stance on gender-affirming care—especially regarding services provided to minors—clear.

On December 22, 2025, the Federal Trade Commission (“FTC”) took its first step in enforcing its August 2024 Consumer Review Rule (“Rule”) that regulates online companies’ moderation and curation of user reviews, by issuing warning letters to 10 unidentified companies alerting them of their potential violations of the Rule, and cautioning that continued noncompliance could lead to enforcement action and substantial civil penalties. The FTC warning letters directed each recipient to immediately cease and desist from any non-compliant practices and required the company to confirm in writing the steps taken to ensure ongoing compliance with the Rule.

Earlier this month, the Department of Justice (DOJ) announced that Swiss Automation Inc., an Illinois-based precision machining company, agreed to pay $421,234 to resolve allegations that it violated the False Claims Act (FCA) by inadequately protecting technical drawings for parts delivered to Department of Defense (DoD) prime contractors.  This settlement reflects DOJ's persistent emphasis on cybersecurity compliance across all levels of the defense industrial base, reaching beyond prime contractors to encompass subcontractors and smaller suppliers.  The settlement is also a reminder to all contractors not to overlook the often confusing relationship between Controlled Unclassified Information (CUI) and export-controlled information.

On December 19, 2025, the Department of Justice (DOJ) announced a $54.4 million settlement with Ceratizit USA, LLC, a distributor of tungsten carbide products, resolving allegations that the company violated the False Claims Act (FCA) by evading customs duties on products imported from China. This settlement is believed to be the largest ever customs-related FCA resolution, and this high-water mark underscores the government’s heightened enforcement focus on tariff evasion.

On December 18, 2025, the Fiscal Year 2026 National Defense Authorization Act (FY 2026 NDAA) (P.L. 119-60) was signed into law. The Act makes significant changes to defense acquisition, sourcing restrictions, and interactions between the Defense Industrial Base (DIB) and the Department of Defense (DOD). 

The regulatory environment for skilled nursing facilities (SNFs) is shifting rapidly, creating challenges and uncertainties for providers across the country—and especially those in New York. While the Trump administration has rolled back federal nurse staffing mandates, state-level requirements remain in full force, and new federal ownership disclosure rules are set to take effect in January 2026. Even as federal enforcement slows, state regulators appear primed to intensify oversight of nursing home operators by enhancing Certificate of Need (CON) review processes.

On December 16, 2025, the European Commission published its proposal for a regulation establishing a European Biotech Act to strengthen the EU's biotechnology and biomanufacturing sectors with a primary focus on health.

The European Commission has proposed targeted amendments to the Medical Devices Regulation 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). The amendments are intended to simplify the rules, reduce the administrative burden, and enhance the predictability and cost-efficiency of notified body certification, while maintaining high public health and patient safety standards.

In October 2025, the Second Circuit addressed a recurring procedural issue: the standard of review district judges must apply to objections to magistrate judge reports and recommendations (“R&Rs”) on dispositive motions. In Nambiar v. The Central Orthopedic Group, LLP, the Second Circuit clarified that district judges are required to conduct a de novo review of any portion of an R&R to which a party has made timely and specific objections—even when those objections restate arguments previously made before the magistrate judge. This decision resolves confusion stemming from district courts that have limited de novo review to "new" arguments, and it sets clear expectations for how parties should challenge R&Rs going forward.

Bid protest practitioners in recent years have witnessed agencies’ increasing efforts to limit the production of documents and information in response to Government Accountability Office (GAO) bid protests—often will little pushback from GAO. This practice has underscored the notable difference in the scope of bid protest records before GAO versus the Court of Federal Claims. However, in Tiger Natural Gas, Inc., B-423744, Dec. 10, 2025, 2025 CPD ¶ __, GAO made clear that there are limits to the scope of redactions, and GAO will sustain a protest where there is insufficient evidence that the agency’s actions were reasonable.

In July 2025, President Trump signed Executive Order (EO) 14319, Preventing Woke AI in the Federal Government, to preclude the federal government from procuring artificial intelligence (AI) models that incorporate “ideological biases or social agendas,” including “diversity, equity, and inclusion.” The EO mandates that the federal government purchase only large language models (LLMs) developed according to two “Unbiased AI Principles” — that they be “truth-seeking” and show “ideological neutrality.” To implement these principles, the EO directed the Office of Management and Budget (OMB) to issue guidance.

As microplastics begin making headlines and sparking scientific inquiry into the impacts of these pervasive particles, state legislators, regulators, and law enforcers—as well as private plaintiffs’ counsel—are taking action. In California, a bipartisan coalition of legislators passed AB 823, expanding the scope of an existing state ban on products containing plastic microbeads. Governor Newsom vetoed the bill, citing concerns that the ban would inadvertently slow the adoption of non-plastic alternatives.

On December 12, 2025, the U.S. Government Accountability Office (GAO) released its annual report on bid protests for fiscal year 2025, containing the full statistics shown below:

After hosting a series of workshops and issuing multiple rounds of materials, including enforcement notices, checklists, templates, and other guidance, the California Air Resources Board (CARB) has proposed regulations to implement the Climate Corporate Data Accountability Act (SB 253) and the Climate-Related Financial Risk Act (SB 261) (both as amended by SB 219), which require large U.S.-based businesses operating in California to disclose greenhouse gas (GHG) emissions and climate-related risks. CARB also published a Notice of Public Hearing and an Initial Statement of Reasons along with the proposed regulations. While CARB’s final rules were statutorily required to be promulgated by July 1, 2025, these are still just proposals. CARB’s proposed rules largely track earlier guidance regarding how CARB intends to define compliance obligations, exemptions, and key deadlines, and establish fee programs to fund regulatory operations.

In its recently published FY 2025 Annual Report (Report), the Civilian Board of Contract Appeals (CBCA) provided detailed statistics about appeals involving disputes between contractors and civilian agencies.  This past year, the civilian agencies with the highest number of docketed claims at the Board were the Department of Veterans Affairs (70 appeals), the United States Agency for International Development (43 appeals), the General Services Administration (36 appeals), the Department of State (12 appeals ), and the Department of Education (12 appeals).  These agencies accounted for 173, or approximately 78%, of the 221 Contract Disputes Act (CDA) appeals docketed at the Board. 

On December 11, 2025, President Trump signed a much-anticipated Executive Order that seeks to forestall state regulation of artificial intelligence (AI) by threatening federal lawsuits and the withholding of some federal funds and calls for a national policy framework on AI. The Executive Order, Ensuring a National Policy Framework for Artificial Intelligence (EO), declares it the policy of the administration “to sustain and enhance the United States’ global AI dominance through a minimally burdensome national policy framework for AI.”

On 27 November 2025, the European Commission adopted the EU Bioeconomy Strategy 2025 (the Strategy), confirming the bioeconomy as a central pillar of Europe’s industrial, sustainability, and competitiveness agenda. The bioeconomy covers activities that deliver sustainable solutions based on biological resources, including biomass, residues, byproducts, and biogenic carbon, across sectors such as agriculture, forestry, fisheries, biomanufacturing, food, health, energy, materials, and construction.

Every year since 1979, the Armed Services Board of Contract Appeals (ASBCA) has issued a Report of Transactions and Proceedings (Report), which provides helpful statistics for contractors and practitioners regarding the ASBCA’s docket and success rates for contractor litigation and ADR. The ASBCA published its FY 2025 Report on October 30, 2025. 

On January 1, 2026 (“Effective Date”), the New York LLC Transparency Act ("New York Act”) is scheduled to take effect, introducing new disclosure requirements for limited liability companies (“LLCs”) formed or registered to do business in New York State.  The New York Act is expected to impose the type of broad beneficial ownership requirements the federal CTA and rules implementing it was designed to require, before the federal government’s decision to limit the scope of the CTA’s beneficial ownership reporting requirements to foreign companies and foreign beneficial owners.

On December 11, 2025, the Council of the European Union and the European Parliament reached provisional agreement on the long-awaited “Pharma Package,” (see the announcement here). The Pharma Package is a comprehensive and major overhaul of the EU legislative framework for pharmaceuticals, which replaces the more than 20-year-old Directive 2001/83 and Regulation 726/2004 and incorporates (and updates) the separate regulations on orphan and pediatric medicines (Regulations 141/2000 and 1901/2006 respectively).