In the last Congress, the BIOSECURE Act (H.R. 8333, 118th) garnered significant attention despite not becoming law. However, support for a revised version of the BIOSECURE Act (BIOSECURE) — which has the potential to restrict or prohibit biopharmaceutical companies and others contracting with the federal government from collaborating or contracting with certain Chinese biotechnology entities as a condition for receiving federal funding — has now resurfaced for potential inclusion in the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2026. Because Congress prioritizes annual passage of the NDAA, and the revised text of BIOSECURE may alleviate concerns that prevented enactment in the prior Congress, the provisions and legislative progress of BIOSECURE call for close attention from life sciences companies and other entities affected by BIOSECURE's provisions relating to "biotechnology equipment or services."
FY26 NDAA Efforts
On July 31, 2025, Senators Bill Hagerty (R-TN) and Gary Peters (D-MI) submitted a new version of BIOSECURE as a floor amendment to the Senate FY26 NDAA (S. 2296). The draft incorporates changes aimed at addressing concerns of certain members — including Sen. Rand Paul (R-KY) and Rep. Jim McGovern (D-MA) — with many House Democrats supporting Rep. McGovern's position. Generally, those members opposed the previous iteration's explicit naming of certain entities and, in their view, its insufficient protections for due process. At this time, it is unclear if the changes in the updated draft will be sufficient to win over the opposition.
As Chairman of the Senate Committee of jurisdiction, Homeland Security and Governmental Affairs, Sen. Paul is uniquely well-positioned to prevent the amendment's inclusion into the NDAA if he believes his concerns have not been adequately addressed. We understand that Chairs and Ranking Members of Senate committees are now reviewing individual pieces of legislation in their jurisdiction to decide whether to sign off on their potential inclusion in the NDAA process, and that Sen. Paul may be seeking unrelated policy items elsewhere in order to secure his blessing.
What's Changed
Below, we outline the key provisions of the proposed BIOSECURE amendment and highlight important changes from the 2024 bill:
- Prohibitions. Like the prior version of BIOSECURE, the draft would prohibit the use of "biotechnology equipment or services" from a "biotechnology company of concern" (BCC) in performance of a federal "contract."
- No Named Companies. Unlike the prior version of BIOSECURE, the draft does not name specific entities as BCCs (i.e., BGI, MGI, Complete Genomics, WuXi AppTec, and WuXi Biologics).
- Reliance on 1260H List. The draft instead
establishes that any entity included in the annual list published
by the U.S. Department of Defense (DoD) as a Chinese military
company operating in the United States (known as the "1260H
List") qualifies as a biotechnology company of concern.
- The draft provides no grandfathering period for such companies.
BIOSECURE's prohibitions would take effect with respect to such
companies60 days after the Federal Acquisition
Regulation is revised with respect to such companies.
- H.R. 8333 (118th Congress) would have grandfathered certain activities and services with the named entities prior to January 1, 2032, provided they were contracted for (including previously negotiated contract options) before the bill's effective date (60 days after issuance of the relevant regulation).
- Depending on when the government issues revised regulations, BIOSECURE's prohibitions could become effective for 1260H companies as late as 970 days (approximately 32 months) after enactment (but could be earlier).
- The 1260H List published by DoD on January 7, 2025 includes, among other companies, the BGI Group (BGI Genomics Co., Ltd., Forensic Genomics International, and MGI Tech Co., Ltd.), but it does not include any WuXi entities at this time.
- This group of companies would also not enjoy the due process protections described below for companies added through a separate administrative process.
- The draft provides no grandfathering period for such companies.
BIOSECURE's prohibitions would take effect with respect to such
companies60 days after the Federal Acquisition
Regulation is revised with respect to such companies.
- Additional BCCs. Like the prior version of
BIOSECURE, the draft provides that the government may, through
annual review, identify additional BCCs that are (1) subject to the
control of a foreign adversary; (2) involved in the manufacturing
or distribution of a biotechnology equipment or service; and (3) a
risk to the national security of the U.S.
- BIOSECURE's prohibitions would become effective with
respect to these companies180 days after the
Federal Acquisition Regulation is revised.
- Depending on when the government issues revised regulations, BIOSECURE's prohibitions could become effective for these companies as late as two years after they are identified as BCCs (but could be earlier).
- The draft would establish a five-year grandfathering period for biotechnology equipment or services produced or provided by these companies, but only if such equipment or services are provided under a contract, or previously negotiated contract option, entered into before BIOSECURE's prohibitions became effective.
- The draft would also establish certain procedural protections for companies identified as potential additional BCCs, including the right to submit information and arguments in opposition to the designation, and, where practicable, implementing "mitigation steps" identified by the government to potentially rescind the designation.
- BIOSECURE's prohibitions would become effective with
respect to these companies180 days after the
Federal Acquisition Regulation is revised.
- Additional Exception. In addition to certain specified activities (certain intelligence activities, services, and procurements for U.S. employees overseas and commercially or publicly available multiomic data) excepted from the previous iteration's prohibitions, the amendment would also allow for the procurement of medical countermeasures and other products in direct response to a public health emergency.
- Definition of Biotechnology Equipment or Service. Like the prior version of BIOSECURE, the draft defines "biotechnology equipment or service" to include any equipment "that is designed for use in the research, development, production, or analysis of biological materials." The updated draft now omits combined mass spectrometry technologies and polymerase chain reaction machines from the definition.
Initial Considerations
Effective dates remain rather attenuated, depending upon how quickly the government takes specific actions post-enactment. In particular, the lack of grandfathering protections, as currently drafted, for the companies included on the 1260H list suggests that such activities and services would need to be terminated in as little as a few months (in the unlikely event the administration meets their obligations as expeditiously as possible) — or up to 970 days (approximately 32 months) after enactment (if the administration uses all of its allowable time pursuant to the legislation).
If the administration uses approximately half of its statutorily allowable time, which we view as more likely than the expedited timeline outlined above, companies would have roughly 17 months to come into compliance. Of note, the bill does not address how future additions to the 1260H list will be treated; the five-year grandfathering and due process provisions would appear not to apply to companies subsequently added by DoD to the 1260H list, although the 60 day period after the Federal Acquisition Regulation is amended to add such companies would presumably also apply before BIOSECURE's prohibitions would take effect with respect to such companies.
Furthermore, as in the 2024 version, the current NDAA amendment defines a federal "contract" as "any contract subject to the Federal Acquisition Regulation issued under section 1303(a)(1) of title 41, United States Code." This would include, for example, the Federal Supply Schedule contract. Our understanding from key sources is that the "contract" definition is not intended to impact the Medicaid National Drug Rebate Agreement or Medicare Part D Manufacturer Discount Program Agreement. There are concerns, however, that the current language needs additional revisions and clarity to achieve an enactment that implements this intent.
Status and Outlook
The Senate is expected to advance the NDAA when they return from the congressional recess in September. The House is expected to vote on their respective version of the NDAA in September as well, and we expect a similar push to include a variation of the BIOSECURE amendment. If the provision, which could be further amended, is included in both the House- and Senate-passed bills, it is a near certainty some variation will be retained in the final product signed by the president. If the bill is not included in the NDAA, we expect the sponsors to push for its inclusion in an end-of-year funding package or Continuing Resolution, though similar hurdles exist with that legislative vehicle as well.
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