BETHESDA, MD — A panel of DC-focused lawyers predicted that the anti-China Biosecure Act is likely headed for final passage during the congressional “lame duck” period between the election and the changeover to the next administration.
The legislation has already passed the House and has bipartisan support in the Senate. It would essentially bar certain China-based biotech contractors like WuXi Biologics from working with US companies.
In an interview with the DC publication Punchbowl, House Speaker Mike Johnson (R-LA) said that he planned to attach the Biosecure legislation to the reauthorization of funds for the Department of Defense, which is likely to pass in the lame duck session. That follows the Senate’s decision to so far not include the Biosecure Act in its version of the defense spending bill.
At Monday’s conference, John Strom, special counsel at Foley & Lardner and former senior counsel on the US House Committee on Energy and Commerce, told attendees the bill has a 90% to 95% chance of final passage.
Strom added via email to Endpoints News that he thinks it’s likely to pass due to its bipartisan support in both chambers, lack of CBO score (limited budget impact), and because the “House version addressed many of industries’ publicly raised concerns about the Senate version.”
The three other lawyers on the panel agreed that the odds of Biosecure’s passage are high. Aaron Cummings, co-chair of the law firm Crowell’s government affairs group, told Endpoints in a phone interview that he thinks the chances are as good as 75%.
But major differences between the more vague Senate version and the more recently updated House version leave a lot of questions open.
“I suspect that the Senate will probably hew a little closer to the House version of the bill,” Cummings told Endpoints, because it’s “the latest iteration.” He said there was an effort in the House to try to keep the Senate informed of those changes to hopefully ease passage.
There are still details to work out, including what types of relationships with WuXi AppTec, WuXi Biologics and other Chinese companies of concern would be affected by the legislation. Lawmakers also need to decide how to structure a safe harbor for drug developers that already work with the Chinese companies.
“There’s been an effort in the safe harbor provision, for example, in some of the definitional sections, to try to give people a little bit of cover and just ensure people that if you already bought this equipment, you’re not going to have to worry about it,” Cummings said. “But it just gets gray and murky when you think about things like cell lines or tech transfers.”
Strom added during the panel that neither HHS nor FDA has weighed in yet on the legislation and what it would mean to end relationships with the Chinese firms.
“At the end of the day, it’s their stakeholders. It seems logical that there’s a role for the FDA to ease the decoupling,” he said.