We’re reading about BIOSECURE Act, FDA Covid vaccine data

Good morning, everyone, and welcome to another working week. We hope the weekend respite was refreshing and invigorating, because the time has come to return to the familiar treadmill of online meetings, phone calls, and deadlines. But you knew this would happen, yes? After all, the world continues to spin, no matter how we try to slow it down. So to cope, we are firing up the aging coffee kettle to brew another cup of stimulation. Our choice today is ever-flavorful blueberry cobbler. As always, you are invited to join us. Meanwhile, here is the latest menu of tidbits for you to digest. We hope your journey today is meaningful and productive. And of course, do keep in touch. We appreciate the feedback and ideas. …

Legislation to restrict U.S. drugmakers from using key Chinese contract manufacturers was dealt a major blow when senators left it out of a must-pass defense budget bill this weekend, STAT tells us. The BIOSECURE Act would prohibit pharmaceutical and biotechnology companies from using services or equipment from Chinese “companies of concern,” including WuXi AppTec and WuXi Biologics, in work that is contracted or funded by the U.S. federal government. Industry has come to rely heavily on those companies for contract manufacturing and other important services. Without the WuXi companies, costs for those services would rise. BIOSECURE has unusually strong bipartisan support as lawmakers in both parties want to maintain America’s dominance in biotechnology and reduce China’s importance to the drug supply chain. But the bill’s momentum slowed in the past few months. Lawmakers narrowed its scope and, when it came up for a House vote in September, 81 of them voted against it. All but two of the no-votes were Democrats, including some in leadership.

A U.S. judge ordered the U.S. Food and Drug Administration to publicly disclose more information underpinning its authorization of Covid-19 vaccines, after failing to persuade the court to end the public records lawsuit, Reuters reports. In a ruling, U.S. District Judge Mark Pittman in Fort Worth, Tx., ordered the agency to produce its “emergency use authorization” file to a group of scientists who wanted to see licensing information that the FDA relied on to approve the Pfizer-BioNTech coronavirus vaccine. “The Covid-19 pandemic is long passed and so has any legitimate reason for concealing from the American people the information relied upon by the government in approving the Pfizer vaccine,” wrote Pittman, appointed in 2019 by then-President Trump. The lawsuit, filed in late 2021, attracted attention after the FDA said it could take decades to process and disclose records to Public Health and Medical Professionals for Transparency, the group that brought the case. The FDA said in a court filing that it has produced more than 1 million pages of records in the lawsuit. The filing also said that it had set up “unprecedented and extraordinary operations” — spending more than $3.5 million — to comply with Pittman’s directives to speed its search and delivery of responsive records.