Senate Advances Revised BIOSECURE Act — What it Means for Biotech and Biopharma

On October 9, 2025, the U.S. Senate took a major step toward embedding a retooled BIOSECURE Act into national policy by approving it as an amendment to the National Defense Authorization Act (NDAA). While the House’s version of the NDAA does not yet include BIOSECURE, the Senate’s move marks a renewed push for legislation that would reshape how federally funded biotechnology and pharmaceutical actors engage with certain foreign firms. 

Below is a deeper dive into the changes, the stakes, and what’s next. 

The BIOSECURE Act has been in the congressional headlights since late 2023. Its earlier iterations provoked strong opposition from the biopharma industry, largely over the risk of disruption to complex supply chains and research relationships. A key flashpoint was that the original bill explicitly named Chinese firms like BGI, MGI, WuXi AppTec, and WuXi Biologics as “biotechnology companies of concern,” automatically subjecting any deal with them (direct or indirect) to prohibition.  lack of carve-outs or more gradual transition paths drew criticism that it threatened existing contracts, delayed development, and stifled collaboration. 

Though the House passed its version of BIOSECURE in September 2024, the Senate version of the NDAA that year did not include it.  

The new Senate-approved draft attempts to address industry concerns by removing the fixed company list and instead linking the definition of a “biotechnology company of concern” to the annual DoD “1260H” list of Chinese military companies. Under that list (as of the January 2025 edition), BGI and MGI are included, but currently WuXi entities are not. In other words, the amendment replaces static targeting with a dynamic linkage to an existing national security list. 

Another major adjustment: the updated draft drops explicit references to mass spectrometry and PCR machines from the prohibited “biotechnology equipment or service” definition. Because those methods are nearly universal in pharmaceutical R&D and manufacturing, their exclusion markedly narrows the bill’s footprint.  

Other refinements include technical changes to how OMB (Office of Management and Budget) may designate additional companies of concern, as well as adjustments in timing and implementation provisions. Some observers view these changes as calibrated to make the legislation more digestible to stakeholders.  The Senate passed the defense bill (with this amendment) by a 77–20 vote.  

What the Revised BIOSECURE Act Would Do (If Enacted) 

At its core, the BIOSECURE Act aims to limit how federal funds and contracts may flow to biotechnology or life sciences actors tied to entities that pose national security risks. Some of the key elements: 

• Procurement and contracting limits: Federal agencies would be prohibited from procuring or obtaining biotechnology equipment or services from a “company of concern.” They would also be barred from contracting (or renewing contracts) with entities that use such equipment or services in fulfilling federal work.  

• Designation authority: OMB, in coordination with DoD and other relevant agencies, would compile and publish a list of biotechnology companies of concern. The DoD’s “Chinese military companies” (1260H) list would serve as a baseline.  

• Effective dates and transition periods: The timing when prohibitions take effect depends on whether a firm is already on the list, newly added, or designated via the OMB process. In earlier drafts, existing contracts were often grandfathered or given a wind-down window (e.g. up to five years).  

• Waivers and exceptions: The legislation allows for case-by-case waivers (with OMB involvement) and narrowly defines safe harbors (for example, if a company sells off an affected product line).  

• Scope limitations: Intelligence activities and certain health services (for federal employees or contractors overseas) are carved out.  

It’s worth noting, even though the Senate approved the amendment, the bill is not law yet. The House must include the same language during reconciliation, and the final NDAA must gain presidential assent.  

Likely Impact on Biopharma & Service Providers 

• Supply chain re-engineering: Firms relying on Chinese CDMOs, CROs, or equipment vendors will need to assess whether current relationships might fall under prohibition. Strategic diversification or alternate sourcing plans will become more urgent.   

• Contracting risk: Entities with federal contracts must ensure that downstream subcontracts or supplier relationships do not trigger violations. The ripple effect could reach into academic labs, manufacturing, and assay providers.   

• Uncertainty and timing: Because the effective dates can vary depending on designation, organizations may face abrupt cutoffs requiring rapid transitions.  

• Competitive repositioning: Some non-Chinese CDMOs or biotech suppliers may gain new business opportunities, especially from U.S. firms seeking “safe” partnerships.   

Challenges and Critical Unknowns 

• Transparency and appeals: The act provides limited procedural mechanisms for firms to contest designations or be informed of underlying evidence. Some designees may receive notice only after listing, with restricted rights to challenge.  

• Regulatory implementation: OMB guidance, revisions to the Federal Acquisition Regulation (FAR), and other implementing rules will shape the practical reach of the law. Delays or ambiguities in those rules could leave companies scrambling.  

• International and scientific ripple effects: Because biotech and biopharma operate globally, cutting ties with certain Chinese entities could compromise access to talent, cross-border collaboration, or reagents.  

• Policy dynamics & politics: Senate committees (notably the chair of Homeland Security and Governmental Affairs) retain leverage to hold up or alter content during markup.  

Practical Considerations for Stakeholders 

1. Audit current relationships – Map all vendors, suppliers, subcontractors, and collaborators that perform biotechnology-related work and assess risk exposure under the revised definitions. 

2. Engage proactively – Provide feedback through industry associations, meet with congressional staff, and advocate for clarity, procedural protections, and transition flexibility. 

3. Prepare mitigation plans – Identify alternative partners, domestic suppliers, or dual sourcing strategies to reduce reliance on any entity that may be designated. 

4. Monitor guidance and rulemaking – Closely follow OMB, DoD, and FAR updates to understand compliance timing and evolving interpretations. 

5. Scenario planning – Simulate worst-case disruption, including abrupt contract terminations, to stress-test business continuity plans. 

The Road Ahead 

The Senate’s approval of BIOSECURE as a defense amendment is an important signaling event. Because the NDAA is a must-pass vehicle, it provides a plausible path to law—but that path is far from guaranteed. As things stand: 

• The House must accept or reconcile the BIOSECURE language in its version of the NDAA.  

• Committee chairs have power to block or reshape the bill during markup, and debate over procedure, transparency, and transition terms remains active.  

• Even if included in the final Defense Authorization, implementation rules (OMB guidance, FAR updates, agency waivers) will determine how rigid or flexible the requirements become. 

• The biotechnology, pharmaceutical, and life sciences sectors should anticipate further refinements, industry pushback, and perhaps additional compromise amendments. 

For those in Michigan’s biosciences ecosystem, whether biotech startups, service providers, CDMOs, or research labs - now is a critical moment to evaluate exposure, plan ahead, and engage. The contours of national security policy are reshaping the regulatory environment for biotech, and with that comes both risk and opportunity.