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On Thursday, October 9, 2025, the Senate passed its version of the 2026 National Defense Authorization Act (the "NDAA"), which includes the latest version of the BIOSECURE Act (the "Amendment") as an amendment.1 The House version of the NDAA does not include the Amendment, and negotiations will be ongoing regarding the contents of the final NDAA.2 The legislation, if enacted, would prevent federal agencies and contractors from using biotechnology equipment or services provided by companies owned or controlled by foreign adversary governments.3 Specifically, it would prohibit federal agencies from procuring, contracting with, or utilizing biotechnology equipment or services from designated "biotechnology companies of concern" ("BCCs") and would bar contractors and grant recipients from using such equipment or services in the performance of federal contracts or grants.4
Updates from the 2024 BIOSECURE Act: WuXi No Longer Named
The current Amendment reflects The current Amendment reflects key updatesfrom prior versions of the BIOSECURE Act, which received bipartisan support in 2024 but was not enacted. Notably, the Amendment has been revised to address concerns raised on the 2024 version's approach in naming specific companies. Unlike the 2024 version, the Amendment does not specifically name WuXi AppTec, WuXi Biologics, BGI, MGI, or Complete Genomics as BCCs.5 Instead, it refers to entities included in the "List of Chinese Military Companies" maintained by the U.S. Department of Defense.6 This list includes BGI Group (BGI Genomics Co., Ltd., Forensic Genomics International, and MGI Tech Co., Ltd.), which was named in the 2024 version of the proposed BIOSECURE Act, but does not include Complete Genomics, WuXi AppTec, or WuXi Biologics.7
Consistent with the 2024 version of the bill, the second manner in which an entity may be identified as a BCC is by the Director of the Office of Management and Budget (the "OMB") designating a company as (i) being subject to the control of the government of a foreign adversary, (ii) involved in the manufacturing, distribution, provision, or procurement of biotechnology equipment or services, and (iii) posing a risk to the national security of the United States.8 The third factor is determined based on the entity's engagement with, support from, or affiliation with a foreign military; providing multiomic data obtained by biotechnology equipment or services to the government of a foreign adversary; or obtaining human multiomic data by biotechnology equipment or services without express, informed consent.9 The OMB will publish a list of entities that constitute BCCs no later than one year after the Amendment's enactment based on a list of entities suggested by the Secretary of Defense in coordination with the U.S. Attorney General and other agencies involved with national safety and security.10
In addition, unlike the 2024 version of the bill, the Amendment excludes the procurement of medical countermeasures, medical products, and related supplies in direct response to a declared public health emergency from the prohibitions on federal contracting or funding.11 We also note that the current Amendment as included in the NDAA is nearly identical to the version re-introduced to the Senate in July 2025, as discussed in our September 2025 Alert.12
Notable Features of the BIOSECURE Act
The majority of the bill has remained unchanged from the 2024 version passed by the House of Representatives, which included the following features described in our September 2024 Alert:
- Companies given five-year grandfathering window. The bill contains a grandfathering clause for contracts entered into with BCCs prior to the "effective date" of the Act (the effective date being the date 180 days following such date that the Federal Acquisition Regulation ("FAR") is revised).13 These contracts would be excluded from complying with the Act until five years after the FAR is revised.14
- A safe harbor provision is included. The bill offers a "safe harbor" provision that clarifies that "biotechnology equipment or services" will not include those that were formerly, but no longer, produced or provided by BCCs.15
- "Contract" is defined using the Federal Acquisition Regulation. The bill defines "contract" as "any contract subject to the Federal Acquisition Regulation issued under section 1303(a)(1) of title 41, United States Code."16 Medicaid national drug rebate agreements and Medicare Part D manufacturer discount agreements are not FAR-based contracts, as they do not provide for federal government procurement of goods or services. However, FAR applies to nearly all government contracts for the procurement of goods and services, including potential supply agreements with the Department of Veterans Affairs and certain contracts with the Centers for Disease Control and Prevention.17
- A waiver program is included. The head of an executive agency may waive the operative prohibitions of the Act, with approval from the OMB.18 The duration of a waiver is a year, with an option for a one-time 180-day extension.19 An agency head may provide a waiver only if such extension is in the national security interests of the United States, including overseas health care that supports the mission of U.S. government employees.20
- Exceptions. The bill contains exceptions for activities that are categorically excepted from the prohibitions, including intelligence activities, certain overseas health care services, and commercially/publicly available multiomic data.21 The Amendment adds declared public health emergencies to the list of exceptions.22
Biotechnology Industry Takeaways
By not including WuXi AppTec and WuXi Biologics in the list of initial BCCs, the Amendment would be much less impactful on life sciences companies, if enacted, than the 2024 version of the bill would have been. Nonetheless, if the Amendment becomes law, life sciences companies and institutions would want to assess their supply chains and existing business practices to identify equipment and services sourced from BCCs or potential BCCs. If enacted, federal agencies would be barred from procuring, contracting with, or using biotechnology equipment or services from BCCs and from contracting with or extending grants to entities using such equipment or services in the performance of such federal contracts or grants. To maintain eligibility for doing business with the federal government, biotechnology companies and institutions would need to monitor companies of concern and consider exiting contractual arrangements with actual or potential BCCs.23
Businesses and institutions would also have to determine whether materials or services provided by BCCs used in federal contracts fall under the Amendment's definition of "biotechnology equipment or services," which includes items and services related to genetic and biological materials.24 The OMB, in consultation with other agencies, may periodically expand this definition for national security, so companies should monitor the list for changes.25
Footnotes
1. S. Amdt. 3841 to S. 2296, 119th Cong. (2025).
2. H.R. 3838, 119th Cong. (2025).
3. S. Amdt. 3841 to S. 2296, 119th Cong. (2025) § (b).
4. Id.
5. S. Amdt. 3841 to S. 2296, 119th Cong. (2025); S. 3558, 118th Cong. (2024).
6. S. Amdt. 3841 to S. 2296, 119th Cong. (2025) § (f)(2)(A).
7. S. Amdt. 3841 to S. 2296, 119th Cong. (2025) § (f)(2)(A); Press Release, Jan. 7, 2025, U.S. Department of Defense, DOD Releases List of Chinese Military Companies in Accordance with Section 1260H of the National Defense Authorization Act for Fiscal Year 2021, https://www.defense.gov/News/Releases/Release/Article/4023145/dod-releases-list-of-chinese-military-companies-in-accordance-with-section-1260/.
8. S. Amdt. 3841 to S. 2296, 119th Cong. (2025) § (f)(2)(B).
9. Id. at § (f)(2)(B)(iii)(I)-(III).
10. Id. at § (f)(1).
11. Id. at § (e)(4).
12. S. Amdt. 3841 to S. 2296, 119th Cong. (2025) § (c)(3)(A); S. 3558, 118th Cong. (2024).
13. S. Amdt. 3841 to S. 2296, 119th Cong. (2025) §§ (c)(3)(A), (c)(2).
14. Id. at § (c)(3)(A).
15. Id. at § (c)(3)(B).
16. Id. at § (k)(3).
17. 48 C.F.R. 2.101.
18. S. Amdt. 3841 to S. 2296, 119th Cong. (2025) § (f)(2)(A) and § (d)(1)(A).
19. Id. at § (d)(1)(B).
20. Id.
21. Id. at § (e).
23. Id. at § (e)(4).
24. See Id. at §§ (a)(1)-(2), (b)(1)-(2).
25. Id. at § (k)(2).
26. Id. at § (f)(1).
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