Heparin Calcium

Two days after announcing plans to shut down an FDA lab devoted to ensuring the US drug supply remains safe and potent, the Trump administration has changed plans and will leave the lab open, Endpoints News has learned. The St. Louis lab, known as the Office of Testing and Research, is one of the drug agency’s most important facilities for ensuring drugs are of high quality. In addition to its day-to-day work, the lab has been called in to investigate high-profile drug safety issues. In 2008, for example, it led a probe into contaminated supplies of the blood thinner heparin, which likely killed dozens of Americans and was eventually traced back to a supplier in China. More recently, it led a probe into common heartburn medications that were found to have unsafe levels of nitrosamine, a carcinogen. That investigation helped lead to popular products like Zantac and related over-the-counter drugs being pulled from shelves. “They are the FDA’s premier drug analysis lab,” former FDA Acting Commissioner Janet Woodcock told Endpoints by email. “Congress has been constantly on FDA to make sure imported drugs are of adequate quality, and the St. Louis lab is the foundation of that.” The lab was one of about 30 FDA facilities whose leases were marked for termination by Elon Musk’s Department of Government Efficiency, or DOGE, which has been charged with slashing government spending but has sometimes had to reverse course on its actions when it has taken steps to shut down critical government functions. As of Wednesday afternoon, the lease for the lab was still posted on DOGE’s “Wall of Receipts.” DOGE claimed on the site that ending the lease on the 50,000 square-foot St. Louis lab, which recently underwent a $10 million renovation, would save $20 million. In some other cases, DOGE’s inaccurate claims of cost savings have been pulled from its website. DOGE has also said it has reversed other sudden cuts — such as to an Ebola prevention program (reporting by the Washington Post has shown that the Ebola program hadn’t been restored , as of last week). FDA and HHS spokespeople didn’t immediately respond to requests for comment. A spokesperson from the federal government’s General Services Administration did not respond to Endpoints’ inquiry on the St. Louis lab and instead said it’s working to secure suitable alternative space for any canceled leases. Additional details of the planned closure, and then the action to reverse it two days later, were relayed to Endpoints by two scientists at the facility who had been briefed by FDA leadership. Endpoints is not naming them to protect them from retaliation. “We’re relieved our lab won’t close,” one of the researchers said. But they added that they expect more cuts to come to the agency: “We know we are not in the clear … regarding our jobs or our work.” On Monday, staff at the lab were told that the lease for the facility was being terminated. It wasn’t clear where staff would go, or if their jobs would remain. Equally important, it wasn’t clear what would happen to hundreds of millions of dollars in characterization and testing equipment that’s used to evaluate drugs, or where those activities would be redirected. “The decision to terminate the St. Louis lab will cost more money than it saves,” one scientist at the lab told Endpoints on Tuesday. The two scientists, and other people familiar with the lab’s work, described the research and testing conducted there as essential for ensuring the availability of complex generics and biosimilars in the US. The ISO-certified testing and research lab in St. Louis serves the FDA’s wide-ranging Office of Pharmaceutical Quality.