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Inspectors accused of protecting America’s drug supply say they are upset by the Food and Drug Administration’s deep cuts, despite the Trump administration’s promise to maintain the government’s investigative power.
Dozens of people have been let go of helping to coordinate travel for complex testing in foreign drug manufacturing plants, but some have been rehired, but inspectors said the ongoing tensions in the industry, spreading across more than 90 countries, could run out of staff and undermine the safety of the drugs used by millions of people.
For years, inspectors have discovered dirty equipment, contaminated supplies and fraudulent test records at some overseas factories. This is a serious violation of safety and quality that will make consumers sick or kill them. Last month, Propublica reported that generic immunosuppressants for transplant patients could be too fast when taken and increase the risk of renal failure. The drug was made in an Indian factory and had a history of quality violations, seasoned from the US market. The company previously told Propublica it believes the drug is safe.
In April, more than 3,500 FDA employees were fired under US Department and Health and Human Services Secretary Robert F. Kennedy Jr. “We’re not just reducing bureaucratic sprawl, we’re reconciliating our organization with core missions and new priorities to reverse the chronic disease epidemic,” Kennedy said.
At the time, the agency said the cuts would not affect inspectors. Kennedy has since announced that HHS will reverse 20% of agency-wide cuts. In news reports describing the layoffs at the FDA, Kennedy did not specify how many people would be revived.
Propublica has spoken to 10 current and former FDA staff and leaders in recent weeks. This said the loss of support staff slowed critical investigations and little relief was realized. When they were searching for a new job, they most refused to be named because they were not allowed to speak publicly within the industry or were not allowed to speak publicly.
A veteran drug inspector said nearly 70 people who helped arrange a contingency plan for travel, budgets, translators and investigations have been fired. Only about a third were taken home, so travel clearance and visa adjustments were made for weeks of testing, and forced by a few busy managers for testing that could include stops in multiple countries.
“It’s difficult to complete the test,” the investigator said. “The pace has slowed down. We can’t inspect many sites.”
A HHS spokesperson said in an email that the tests were not affected by downsizing. The agency did not address questions about how many people were let go, resurrected, or whether additional support would be raised.
“To be clear, this important work continues as FDA inspectors were not affected,” the agency said.
However, two former FDA committee members and the agency’s longtime drug safety director said the loss of support staff is undermining one of the FDA’s most important missions when Americans acquire most of the generic drugs from overseas manufacturers. This includes chemotherapy treatments, sedatives, antibiotics and drugs from hospital crash carts.
“We didn’t fire doctors or nurses in the hospital, we fired all lab technicians, all order, all phlebotomists, but oh, but the doctors and nurses are still there,” said Janet Woodcock, who ran the agency’s centre for drug evaluations. He’ll be missing. ”
Beyond staff cuts, the departures of long-standing investigators and leaders over the past few months have led to fewer experienced people tasked with eradicating dangerous and sometimes deceptive manufacturing practices.
Research forces examining potential safety issues with drugs, vaccines, medical devices and other products have had retention issues for many years. Inspectors leave frequently, so hiring Denghibition did not allow the FDA to move forward.
Between 2022 and 2024, the agency hired 105 inspectors, but roughly the same number remains, with the testing pool leaving around 230 people, according to the Government Accountability Office, the Congress’s watchdog division.
About a third of GAOs had no experience in conducting independent foreign testing.
Two FDA inspectors said the agency would need to add between 100 and 200 experienced investigators to perform the work.
The work may be tough. Some inspectors travelling to drug manufacturing plants overseas are 15 weeks apart a year. Some people describe the threat of violence by company managers, day on airplanes, trains in oppressive heat and the long nights preparing inspection reports before heading to the next stop.
The loss of cuts to experienced investigators and support staff also beat other inspectors.
“I’m totally shocked that they don’t support or promote our people who can do decent testing,” said an investigator who scrutinizes factories that produce vaccines, cell therapy and other biological products. “You’re added to the chaos.”
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Dozens of employees who processed technology support, facilities, supplies and equipment were also rejected, narrating their daily operations at the agency. One current employee recalled that a colleague was unable to find a replacement battery for a computer mouse and that he couldn’t return because others had locked themselves from their office and had no one to open the door.
Even before the layoffs, the FDA’s investigative power struggled to monitor drug manufacturing plants in countries, including India and China, particularly during the Covid-19 pandemic, increasing alarms that serious manufacturing lapses may not be checked in Congress. In 2023, the FDA received more than a million reports from doctors, patients and others about consumers who suffered product quality issues and side effects on drugs, FDA data shows.
“Things will be overlooked,” former FDA inspector Patrick Stone said of the layoffs. “We’re going to have less safe medicines.”
The Trump administration has spoken little about layoffs in recent weeks, but Kennedy told Congress later last month that more than 900 employees at the Centers for Disease Control and Prevention and the National Institutes of Health have recovered.
In May, the FDA announced that it would expand its use of unpublished inspections at overseas factories. FDA Commissioner Marty McCurry has announced that a new AI tool known as ELSA will help identify testing goals.
Current and former employees say that other employees will not make up for the loss.
“We cannot expect inspectors to cherish all the complexities of organizing travel abroad,” said Margaret Hamburg, a former FDA committee member who served under the Obama administration. “You might be told we’re maintaining inspectors, but that doesn’t mean they’ve maintained the infrastructure…it actually supports safe and meaningful inspections.”
Brandon Roberts provided data analysis.
