Congress Enacts BIOSECURE Act: What it Means for the Life Sciences Sector

In late December 2025, Congress completed action on the FY 2026 National Defense Authorization Act (NDAA)and with it, the long-debated BIOSECURE Act has been enacted into law as part of that broader defense package. This development marks a significant policy shift at the intersection of national security, biotechnology, and federal procurement — and life sciences companies should be preparing now for its real-world impacts.

What the BIOSECURE Act Does 

At its core, the BIOSECURE Act directs federal agencies and recipients of federal funds to limit federal contracting, grants, loans, and procurement involving biotechnology equipment or services that pose a risk to U.S. national security. Life science companies will need to understand and adapt to a series of new prohibitions and compliance requirements affecting how federal dollars are spent.   

Key provisions of the enacted law include: 

• Prohibitions on equipment and services from “biotechnology companies of concern.” Federal agencies are barred from procuring or obtaining biotechnology equipment or services from entities deemed a national security risk — particularly those linked to foreign adversaries such as China — and contractors using such equipment in performance of federal contracts are also restricted.   

• Designation authority: The Office of Management and Budget (OMB), in coordination with the Department of Defense (DoD), will publish and maintain a list of “biotechnology companies of concern.” This list will be updated at least annually, and companies can expect opportunities for advance notice and challenge before designation.   

• Phased implementation: After the law’s enactment, OMB has up to a year to publish the first designated list, followed by the Federal Acquisition Regulation (FAR) Council’s revisions to implement the prohibitions. The restrictions take effect 60 days after the updated FAR for DoD-listed entities and 90 days for others.  

• Grandfathering: Existing federal contracts, grants, and loans that involve affected biotechnology equipment/services entered into before the law’s effective dates are generally “grandfathered” for up to five years, giving companies transition time.   

• Limited carve-outs: Certain activities — such as U.S. intelligence operations, some overseas health services for federal personnel, and responses to declared public health emergencies — are excluded from the prohibitions.   

Taken together, these provisions aim to reduce U.S. dependency on foreign biotechnology inputs that might compromise data security or critical research infrastructure, while funneling federal support toward domestic capabilities and vetted partners. 

Why the Law Matters 

For life science companies, the BIOSECURE Act represents more than a new piece of national security legislation — it will reshape how companies interact with federal funding and compliance landscapes. 

1. Federal Funding and Contract Eligibility Will Change 
   If your company relies on federal grants, loans, or defense contracts, you will now need to ensure that neither your own operations nor your upstream vendors use excluded biotechnology equipment or services. Entities that continue to work with designated companies of concern may find themselves ineligible for new or renewing federal awards.  

2. Supply Chain and Vendor Due Diligence Is Essential 
   Life science firms must begin now to thoroughly map their supply chains, identifying where potentially restricted equipment or services may be used — whether in R&D, diagnostics, clinical manufacturing, or data analysis — and plan for alternatives. Given the phased implementation schedule, early action will allow smoother transitions.   

3. Compliance Frameworks Will Evolve 
   Expect new contract clauses tied to the FAR revisions, updated vendor eligibility criteria, and agency guidance documents. Companies should build compliance programs that incorporate list-based screening, supply chain documentation, and risk assessment tools to manage evolving obligations.  

4. Domestic Innovation and Strategic Partnerships May Gain Incentives 
   By restricting access to certain foreign biotechnology services and tools in federally supported contexts, the law may indirectly stimulate stronger domestic biotech ecosystems and partnerships with trusted technology providers. Strategically positioning your company within these networks can be a competitive advantage.   
   

What’s Next for Life Science Companies 

With the BIOSECURE Act now law, the policy focus will shift toward implementation and enforcement. The timeline for OMB’s initial list, FAR updates, and phased prohibitions provides a runway for life science firms to prepare, but the message from policymakers is clear: national security considerations now play a key role in federal biotechnology investment and procurement decisions.  

Companies that proactively assess risk exposure, reconsider supply chain dependencies, and rethink relationships with designated vendors will be best positioned to navigate this new regulatory landscape while maintaining access to federal funding and strategic contracts.