According to a report by foreign media Endpoints News, a group of lawyers from Washington, D.C., predicts that the "Biosecure Act" is likely to be passed during the Congress "lame-duck" session, which falls between the election and the change of the next government.

The bill has already passed the House of Representatives and has bipartisan support in the Senate. On September 19, 2024, the U.S. Senate's official website released the final version of the "Fiscal Year 2025 National Defense Authorization Act" (NDAA), which included 93 amendments. However, it is worth noting that S. Amdt. 2166 (the Biosecure proposal) was not included.

Currently, only three working periods remain for both chambers this year: September 23-27, November 12-22, and December 2-20. On November 5, the U.S. will hold elections for the President, all 435 seats in the House of Representatives, and 33 of the 100 Senate seats.

In an interview, Speaker of the House Mike Johnson stated that he plans to attach the Biosecure legislation to the Defense Department's reauthorization bill, which is likely to pass during the "lame-duck" session. At a meeting on Monday, John Strom, special counsel at Foley & Lardner and former senior adviser to the U.S. House Energy and Commerce Committee, told attendees that there is a 90% to 95% chance of the bill being passed. He added in an email to Endpoints News that he believes the bill is likely to pass because it has bipartisan support in both chambers, lacks a CBO score (indicating limited budgetary impact), and "the House version addresses many concerns raised publicly by the industry regarding the Senate version."

Three other lawyers on the panel also agreed that the chances of the Biosecure Act passing are high. Aaron Cummings, co-chair of the government affairs group at Crowell Law Firm, said in a phone interview with Endpoints that he believes the chances of passage are as high as 75%.

However, the Senate version is more vague, while the House version was recently updated, leaving significant differences between the two that leave many issues unresolved. Cummings told Endpoints: "I suspect the Senate will likely move closer to the House version of the bill," as it is "the most recent version." He said that the House is working to help the Senate understand these changes in hopes of making the bill easier to pass.

Some details remain to be worked out, including how the relationship with companies such as WuXi AppTec, WuXi Biologics, and other related Chinese firms will be affected by the legislation. Lawmakers also need to decide how to provide a safe harbor for drug developers that already have partnerships with Chinese companies.

Strom added during the panel discussion that both HHS and the FDA have yet to comment on the legislation or the potential termination of relationships with Chinese companies. He said, "At the end of the day, these are their stakeholders. It seems logical that the FDA would play a role in easing the decoupling process."

Notably, due to strong concerns from industry insiders, the revised draft of the bill includes a grandfather clause, allowing designated companies to continue fulfilling contracts funded by the U.S. government until 2032. Even American politicians admit that WuXi AppTec plays a crucial role in the global pharmaceutical industry, making it difficult to "decouple" quickly.

Highlights

• Bipartisan support exists for the Biosecure Act, which has passed the House and is anticipated to be attached to the Defense Department's reauthorization bill.
• Only three congressional working periods remain this year: September 23-27, November 12-22, and December 2-20.
• Legal experts estimate a 90% to 95% chance for the bill’s passage, citing bipartisan backing and limited budgetary impact.
• There are unresolved differences between the House and Senate versions of the bill, which may hinder progress.
• Lawmakers must address the impact on U.S.-China partnerships in the pharmaceutical sector, particularly concerning WuXi AppTec and related companies.
• The revised bill includes a grandfather clause, allowing certain companies to fulfill U.S. government contracts until 2032.