Nearly two years after its introduction as a bill during the last U.S. Congress, the Biosecure Act has survived an election and a presidential transition and appears poised to become law. But this version, tucked into the nation's annual defense bill, features some changes from the first iteration.
Both the House of Representatives and the Senate have passed the $901 billion defense bill, sending it to the president's desk for a signature. The White House has said President Donald Trump plans to sign the massive defense package, Reuters reports.
Within the mammoth bill, the Biosecure Act has the potential to raise new hurdles for certain life sciences companies from China, as well as their partners, although the exact effects of the legislation remain tough to fully assess at this stage.
Like the prior version, the updated Biosecure Act prohibits executive U.S. agencies from tapping “biotechnology companies of concern” for equipment or services, according to a summary from the law firm Hogan Lovells.
Importantly, the prohibition extends to federal contracts with drugmakers that would involve using equipment and services from those "companies of concern" under certain circumstances and after effective dates that are laid out in the bill's full text.
Previously, there was a worry among many in the industry that drugmakers could be barred from interacting with federal health insurers—relationships that form a sizable chunk of the industry's U.S. sales—based on broad contracting prohibitions laid out in prior legislation.
The new bill does not broadly apply to "reimbursement/payer contracts such as those supporting federal health programs," according to Hogan Lovells. But the firm says there could be some "collateral" effects around supplying products that rely on inputs from Biosecure-targeted companies.
In addition, under the first version of the Biosecure Act, several China life sciences companies were named and directly targeted. The new bill changes the approach and taps the Office of Management and Budget with coming up with a list of relevant companies "of concern" while also utilizing the Pentagon's Section 1260H list of firms associated with the Chinese military.
On the latter front, biopharma development and manufacturing contracting juggernaut WuXi AppTec could face mounting scrutiny, as Bloomberg recently reported the company is being considered for inclusion in the Pentagon list. A company spokesperson told Fierce that WuXi AppTec is "not affiliated with any government or military institutions and does not meet the statutory criteria for designation on the 1260H List."
The Biosecure Act first surfaced in January 2024 and quickly gained support from lawmakers in both major parties as well as the industry trade group BIO. In the months that followed, discussion emerged about the negative ramifications of a sudden decoupling from Chinese biopharma contracting juggernauts. A later version of the legislation set a 2032 decoupling deadline to address this concern.
Still, the legislation failed to pass into law last year, missing the cut in the 2025 defense spending bill after taking flak from lawmakers like Massachusetts Democratic Rep. Jim McGovern and Kentucky Republican Sen. Rand Paul. Some criticism concerned the prior version's "whack-a-mole" approach of naming individual companies and an overall lack of due process.
The Senate voted to include the new version of Biosecure in the U.S.’ annual defense spending bill back in October.