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March 5, 2025
by Ferdous Al-Faruque

FDA’s St. Louis drug testing lab to remain open despite DOGE claim

Editor’s Note: This article has been updated to include confirmation from an HHS source.
 
The Department of Government Efficiency (DOGE) won’t cancel the lease on a US Food and Drug Administration (FDA) drug testing laboratory in St. Louis, according to sources. While there is no indication for the course reversal, several former FDA officials have highlighted its important role in ensuring the safety and efficacy of drugs that come to market.
 
Earlier this week, DOGE posted on its website that it was canceling leases for 30 FDA field offices, including a 52,000 sq ft drug testing facility described by former agency officials as the most important FDA drug testing lab. However, within a few days of making the announcement, it seems the department has reversed its decision to end the lease that it claimed was worth $2,457,367 annually and would save an estimated $19,249,372. (RELATED: DOGE claims $30M savings from canceling 30 FDA leases, Regulatory Focus, 4 March 2025)
 
Sources at FDA and the Department of Health and Human Services (HHS) have confirmed to Focus that FDA’s St. Louis laboratory facility will remain open. DOGE, however, still has the facility on its list of leases that it has or will cancel on its website.
 
The sources provided no further context regarding what prompted the course reversal. Focus also contacted the General Services Administration (GSA), and the White House but did not receive a response.
 
Howard Sklamberg, a partner at Arnold & Porter and a former FDA deputy commissioner for global regulatory operations and policy, told Focus he was concerned that in the medium- and long-term, closing the testing facility could increase the risk of unsafe or ineffective drugs coming to market in the US.
 
“That laboratory is FDA's most important pharmaceutical lab in the country,” he said. “That laboratory performs most of the testing program overseen by FDA's Center for Drug Evaluation and Research… [and] is an important part of the postmarket surveillance of drugs.”
 
Similarly, former FDA Commissioner Robert Califf told Focus the St. Louis facility was critical to understanding life-saving issues such as adulteration of the blood anticoagulant heparin and nitrosamine adulteration. He said shuttering the laboratory “could easily lead to a regrettable direct impact and serious harm to unsuspecting and vulnerable patients.”
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