FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say
by Victoria Malis, Katherine Dailey and Sadie Leite, Medill Investigative Lab, and Debbie Cenziper and Megan Rose, ProPublica ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as theyre published. Inspectors charged with safeguarding Americas drug supply say they are reeling from deep cuts at the Food and Drug Administration despite promises by the Trump administration to preserve the work of the agencys investigative force.Dozens of people who help coordinate travel for complex inspections of foreign drug-making factories have been let go, and though some have since been rehired, inspectors said the ongoing strain of policing an industry spread across more than 90 countries has exhausted staff and could compromise the safety of medications used by millions of people.For years, inspectors have uncovered dirty equipment, contaminated supplies and fraudulent testing records in some overseas factories serious safety and quality breaches that can sicken or kill consumers. Last month, ProPublica reportedthat a generic immunosuppression drug for transplant patients could dissolve too quickly when ingested, increasing the risk of kidney failure. The drug was made at an Indian factory with a history of quality violations that wasbanned from the U.S. market. The company previously told ProPublica it believes the medication is safe. In April, more than 3,500 FDA employees were laid off under U.S. Department and Health and Human Services Secretary Robert F. Kennedy Jr., a roughly 15% reduction in force. We arent just reducing bureaucratic sprawl. We are realigning the organization with its core mission and our new priorities in reversing the chronic disease epidemic, Kennedy said.At the time, the agency said the reductions would not impact inspectors. Kennedy has since announced that HHS would reverse 20% of the cuts across the agency. Amid news reports describing the layoffs at the FDA, Kennedy did not specify how many people would be reinstated.ProPublica spoke to 10 current and former FDA staff members and leaders in recent weeks, including inspectors who said that the loss of support staff has slowed critical investigations and that little relief has materialized. Most declined to be named because they were not authorized to speak publicly or feared backlash within the industry as they search for new jobs.One veteran drug inspector said nearly 70 people who helped arrange travel, budgets, translators and contingency plans for investigations were laid off. Only about one-third have been brought back, forcing a handful of busy managers to coordinate travel clearances and visas for inspections that can span weeks and include stops in multiple countries.Its difficult to get inspections done, the investigator said. The pace has slowed down. You cant inspect as many sites.In an email, an HHS spokesperson said inspections have not been affected by downsizing. The agency did not address questions about how many people have been let go or reinstated or whether additional help will be brought on.To be clear, FDA inspectors were not impacted, and this critical work continues, the agency said.Two former FDA commissioners and the agencys longtime head of drug safety, however, said that the loss of support staff has undermined one of the FDAs most essential missions at a time when Americans get most of their generic drugs from overseas manufacturers. That includes chemotherapy treatments, sedatives, antibiotics and medications on hospital crash carts.Its like saying, Oh we didnt fire any of the doctors or nurses at the hospital, but we fired all the lab techs, all the orderlies, all the phlebotomists oh, but the doctors and nurses are still left so its fine, said Janet Woodcock, who ran the agencys Center for Drug Evaluation and Research for more than two decades and retired in 2004. A lot of the connective tissue that deals with drug safety and similar things are going to be missing.Beyond the staff cuts, the departures of some longtime investigators and leaders in recent months have left less experienced people tasked with rooting out dangerous and sometimes deceptive manufacturing practices.The investigative unit, which looks into potential safety issues with drugs, vaccines, medical devices and other products, has had a retention problem for years. Inspectors leave so often that even with hiring blitzes, the FDA has been unable to get ahead.Between 2022 and 2024, the agency hired 105 inspectors but about the same number left, leaving the inspection pool with about 230 people, according to the Government Accountability Office, the watchdog arm of Congress.About one-third did not have the experience to conduct independent foreign inspections, the GAO found.Two FDA inspectors said the agency needs an additional 100 to 200 experienced investigators to do the work.The job can be grueling. Some inspectors who travel to overseas drug-making factories can be away for as long as 15 weeks a year. Some have described threats of violence by company managers, days on planes and trains in oppressive heat and long nights preparing inspection reports before they head to the next stop.The loss of experienced investigators and cuts to support staff have also hamstrung other inspectors.I am in utter shock that they dont support and promote those of us who can do a decent inspection, said one investigator who scrutinizes factories that produce vaccines, cell therapies and other biological products. Youre adding to the chaos. Dozens of employees who handled technology support, facilities, supplies and equipment were dismissed as well, snarling some day-to-day operations at the agency. One current employee recalled how a colleague couldnt find replacement batteries for a computer mouse and how another locked herself out of her office and couldnt get back in because there was no one to open the door.Even before the layoffs, the FDAs investigative force struggled to monitor drug-making factories in countries that include India and China, particularly during the COVID-19 pandemic, raising alarms in Congress that serious manufacturing lapses may have gone unchecked. The FDA received more than 1 million reports from doctors, patients and others in 2023 about product quality issues or consumers who had adverse reactions to drugs, FDA data shows.Things will be missed, former FDA inspector Patrick Stone said about the layoffs. We are going to have a lot less safe drugs.The Trump administration has said little about the layoffs in recent weeks, though Kennedy told Congress late last month that more than 900 employees at the Centers for Disease Control and Prevention and the National Institutes of Health had been reinstated.The FDA announced in May that it would expand the use of unannounced inspections at overseas factories, a move that some members of Congress have been pushing for years. And FDA Commissioner Marty Makary announced that a new AI tool known as Elsa would help identify inspection targets.Current and former employees others say that wont make up for the losses.You cant just expect the inspector to take care of all the complexities of organizing their trips overseas, said former FDA Commissioner Margaret Hamburg, who served under the Obama administration. Even though it might be said weve kept the inspectors, that doesnt mean that theyve kept the infrastructure that actually supports safe and meaningful inspections. Brandon Roberts contributed data analysis.
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