Insights

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.

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).

On the morning of December 12, 2025, the Eleventh Circuit heard argument in United States ex rel. Zafirov v. Florida Medical Associates, LLC, et al., No. 24-13581 (11th Cir. 2025). This case concerns the constitutionality of the False Claims Act (FCA) qui tam provisions and a groundbreaking September 2024 opinion in which the United States District Court for the Middle District of Florida held that the FCA’s qui tam provisions were unconstitutional under Article II. See United States ex rel. Zafirov v. Fla. Med. Assocs., LLC, 751 F. Supp. 3d 1293 (M.D. Fla. 2024). That decision, penned by District Judge Kathryn Kimball Mizelle, was the first success story for a legal theory that has been gaining steam ever since Justices Thomas, Barrett, and Kavanaugh indicated they would be willing to consider arguments about the constitutionality of the qui tam provisions in U.S. ex rel. Polansky v. Exec. Health Res., 599 U.S. 419 (2023). In her opinion, Judge Mizelle held (1) qui tam relators are officers of the U.S. who must be appointed under the Appointments Clause; and (2) historical practice treating qui tam and similar relators as less than “officers” for constitutional purposes was not enough to save the qui tam provisions from the fundamental Article II infirmity the court identified. That ruling was appealed and, after full briefing, including by the government and a bevy of amici, the litigants stepped up to the plate this morning for oral argument.

In March 2025, President Trump nominated John A. Squires for the positions of Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (USPTO). After being approved by the Senate Judiciary Committee by a vote of 20-2, Squires was confirmed by the Senate on September 17, 2025, by a vote of 51-47 after anti-filibuster measures were invoked. During and after the confirmation process, Squires emphasized several goals for the USPTO during his time as Director. Such goals included:

On 4 December 2025, the Court of Justice of the EU (CJEU) issued a landmark judgment in the joined cases C-580/23 (Mio v. Asplund) and C-795/23 (USM v. Konektra) concerning copyright protection for “works of applied art” (i.e., utilitarian objects such as tables, furniture, lighting fixtures, sofas, chairs, kitchen appliances, vases, and fashion items).

On December 8, 2025, the U.S. District Court for the District of Massachusetts in State of New York v. Trump held unlawful and vacated the U.S. Department of the Interior’s “Wind Order” implementing President Trump’s January 20, 2025, “Temporary Withdrawal of All Areas on the Outer Continental Shelf From Offshore Wind Leasing and Review of the Federal Government’s Leasing and Permitting Practices for Wind Projects,” 90 Fed. Reg. 8363 (Wind Memo, discussed further in a prior alert). This lawsuit, brought by a coalition of states with Alliance for Clean Energy New York intervening on their behalf, challenges Interior’s implementation, through the Wind Order, of the Wind Memo’s direction to pause processing permits and other approvals necessary to onshore and offshore wind energy development. Notably, the lawsuit does not challenge the other element of the Wind Memo, which withdrew unleased offshore areas from future leasing under the Outer Continental Shelf Lands Act (OCSLA). (Note, even though the Wind Order indicates its effect is temporary, the Wind Memo instructs relevant agencies not to advance wind development projects until a “comprehensive assessment” is completed, and the district court’s order confirms that the affected agencies had no plans to restart permitting activities until that assessment was complete.)

On December 5, 2025, the Small Business Administration (SBA) sent letters to 4,300 current and recent participants in the 8(a) Business Development Program requiring production by January 5, 2026, of financial records, contracting and subcontracting agreements, and employee records.  Below we discuss the genesis of the U.S. Government’s focus on fraud in small business programs, the new SBA request for documents, the coming Treasury audit of preference-based contracts, and more.

In an effort to boost its clinical research industry, Germany has enacted the Medical Research Act or “MRA” (Medizinforschungsgesetz). The MRA introduces significant changes to various German healthcare laws and procedures.

This news bulletin is provided by the International Trade Group of Crowell & Moring. If you have questions or need assistance on trade law matters, please contact Anand Sithian or Simeon Yerokun or any member of the International Trade Group.

California continues its blistering pace in enacting artificial intelligence regulations. In 2024 alone, California enacted 18 AI-related bills seeking to regulate AI tools and increase transparency around AI data disclosure.