Biotechnology companies of concern have the opportunity, within 90 days of receipt of designation notice, to contest designation and may be removed from the list in the case that mitigation steps are possible.
On December 7, 2025, Congress released a final version of the Biosecure Act for congressional consideration, as included in the National Defense Authorization Act for Fiscal Year 2026 (NDAA). Then, on December 10, 2025, the U.S. House of Representatives passed the NDAA, containing the final Biosecure Act language.
Evolution of the Biosecure Act
First proposed in the 2023-2024 legislative session, the Biosecure Act defined companies of concern to include specific companies such as BGI, MGI, Complete Genomics, WuXi AppTec and WuXi Biologics. This, however, could have had a significant impact on the biotechnology industry due to reliance on foreign contract manufacturing organizations, and the bill ultimately failed.
In October, the U.S. Senate passed the Biosecure Act as an amendment to Senate Bill 2296, the NDAA. The bill would prohibit executive agencies from contracting with entities using biotechnology equipment or services produced or provided by biotechnology companies of concern. In September, the U.S. House of Representatives passed its NDAA version (HR 3838), which did not contain Biosecure Act language. Thus, Congress needed to reconcile the two bills.
The October amendment seemed to address this issue. The amendment would prohibit contracting with entities listed on the Department of Defense (DoD) Section 1260H list of Chinese military companies, and their affiliates, subsidiaries or parent companies. As it stands, the DoD Section 1260H list does not include WuXi or Complete Genomics. The October amendment additionally would prohibit contracting with entities engaged in biotechnology research, development, manufacturing or related activities that are considered a national security threat.
This October amendment was pending a House vote before the Rules Committee issued a final draft for review. This final draft of the Biosecure Act, as included in the NDAA, closely reflects the October amendment and continues to restrict the federal government from contracting with (including for loan and grant purposes) entities using biotechnology equipment or services from companies of concern. Biotechnology companies could be designated as companies of concern either by an Office of Management and Budget (OMB) rulemaking based on a list of suggested entities from various agency heads, or the annually published DoD Section 1260H list. The OMB listing would be reviewed annually or upon receipt of a company of concern’s removal request. Biotechnology companies of concern have the opportunity, within 90 days of receipt of designation notice, to contest designation and may be removed from the list in the case that mitigation steps are possible.
The proposed bill would require agency guidance be issued no more than 180 days after publication of the OMB listing.
Notably, the bill contains a safe harbor for drug manufacturers participating in the Medicaid Drug Rebate Program. Such manufacturers would remain compliant with program requirements if deemed to have been eligible to enter into a master agreement with the Secretary of Veterans Affairs, aside from its use of biotechnology equipment or services produced or provided by biotechnology companies of concern.
The Senate is likely to vote on the bill in the coming week.
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