Senate Passes Revised Version of the BIOSECURE Act

On October 9, 2025, the U.S. Senate voted in favor of including a revised version of the BIOSECURE Act as an amendment to the National Defense Authorization Act (NDAA). The bill was not included in the version of the NDAA passed by the U.S. House of Representatives and will be subject to the reconciliation process. The last version of the BIOSECURE Act narrowly failed to pass during last year’s Congress due in part to fervent opposition by the biopharma industry, which would have seen enormous disruption of development and manufacturing operations if the bill was enacted.

Readers can revisit our blog post from last year for detailed background on the Act, but in short, the Act prohibits the government from procuring or funding, or contracting with entities that perform government contracts through the use of, certain “biotechnology equipment or services” from a “biotechnology company of concern.”

Previously, the companies of concern included a specific list of Chinese companies—BGI (formerly Beijing Genomics Institute), MGI, Complete Genomics, WuXi Apptec, and affiliates—and there was a process for the government to add new companies to the list that met certain criteria having to do with control of those companies by “foreign adversaries” (China, Iran, Cuba, North Korea, and Russia) and associated national security risks. This list of companies was the subject of much of the pushback from industry, most acutely the inclusion of WuXi and affiliates, which provide an outsize volume of CDMO services to U.S. biopharma companies.

The new version of the Act that passed the Senate removes this specific list of companies and 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. Although the 1260H List published by DoD on January 7, 2025 includes BGI and MGI, it does not include any WuXi entities at this time. This could be viewed as a limited win for some in the biopharma industry, but a note of caution that in February 2024 a bipartisan group of House and Senate members sent a letter to the Biden administration requesting that WuXi be investigated and potentially added to the 1260H list. Additionally, the revised bill maintains the original process for OMB to designate additional biotechnology companies of concern that meet the criteria under the Act.

Another notable change in the new bill is the narrowing of the “biotechnology equipment or service” that are subject to the Act’s prohibition to include any equipment. While the general definition is still equipment or service “that is designed for use in the research, development, production, or analysis of biological materials,” the updated draft now omits the specific reference to combined mass spectrometry technologies and polymerase chain reaction machines from the prior definition. Carving out these two technologies was a high priority for the biopharma industry due to their ubiquity in product development and manufacturing. For example, in our experience something like 90% of manufacturers use mass spectrometry during the manufacture of small molecule drugs.

The exact effective date of the Act’s prohibitions can vary widely (a few months to a few years) depending on whether the company of concern is currently on the 1260H list, added later to the 1260H list or is added through the OMB process defined in the Act. Additionally, the time can vary depending on how quickly the federal government meets its obligation to issue revised Federal Acquisition Regulations.

We are monitoring whether the BIOSECURE Act makes it through the reconciliation process with the House and any changes to the bill if it is enacted.