The cuts to support the staff of the Food and Drug Administration transfer work to the agency inspectors.
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Stefani Reynolds / Bloomberg via Getty Images
When the Secretary of Health and Social Services, Robert F. Kennedy Jr., announced in March that he would eliminate thousands of jobs from federal health agencies, he promised that he would spare inspectors who would provide food and drugs from America by examining factories around the world.
Kennedy kept his word and was not fire inspectors, but key support employees who managed travel arrangements, reimbursements and others left, according to two current inspectors who spoke under the cover of anonymity because they were not allowed to speak to the media.
Some support staff were invited to come back temporarily. But last week, they were told to go home, the current inspectors said.
This loss of support could make much more difficult to inspect factories producing things like baby formula, eye drops, cinnamon and a range of generic drugs, which have all had manufacturing problems that have led to reminders in recent years. In some cases, people have been injured or died.
“This is the first American defense line for the safety of their food and their medicines,” said a current pharmaceutical inspector.
In response to NPR questions, HHS said in a statement: “The FDA monitored inspection trips and guarantees that the necessary support is in place to continue these functions.”
Travel planning change the inspections
But some inspectors cancel their trips due to staff cuts. A food inspector for food and animals that was not authorized to speak publicly told NPR that they were still waiting to be reimbursed for thousands of dollars in recent travel expenses related to inspection. “I don’t trust the process,” said the inspector.
FDA staff have received an email on April 7 telling them that they are now responsible for their own travel provisions, offering office hours for people who need help. Inspectors say it’s not that simple.
“International trips are extremely complicated,” said food and food inspector. “Some countries need visas, others not. Coordinators have maintained a main list and helped process visa documents. While I made inspections, they kept everything behind the scenes.”
An email of March 11 for FDA staff said that the administration had lowered the limits of the government’s credit card to $ 1. Now, to reserve trips, inspectors need prior approval to increase the credit limit. The drug inspector said that the administrator he had sent by email for authorization had been dismissed. “It is difficult to believe that work will do,” said the inspector.
Inspections were already lacking in goals
The support reduced to inspectors could exacerbate longtime problems.
According to a recent report by the government of the government, endowment problems have caused the FDA to cause less medication inspections in 2023 than before the COVVI-19 pandemic, when such inspections were interrupted. “Since its resumption of inspections, the FDA has struggled to keep the staff,” said the report. “From November 2021 to June 2024, the vacancy rate among investigators who inspected foreign and national manufacturers increased from 9% to 16% – which resulted in fewer inspections.” The concerns concerning remuneration and the balance of work-life have contributed to turnover, according to the report.
The agency has also not achieved its objectives of foreign or national food inspection since 2018, according to another GAO report.
Peter Baker, who spent 10 years as a FDA drug inspector before leaving in 2019, said that he was unable to inspect the facilities, especially in countries like China and India, it’s “really a big problem”.
“This matters a lot because most of our generic products are manufactured in the world regions that are semi-regulated or unregulated,” said Baker, who is now heading a consulting company called Live Oak Quality Insurance. “Thus, the only external eyes that will examine the quality system that supports these drugs that these patients will possibly take is the investigator of the FDA. They can be the only person with an independent lens which will examine the conditions under which these products are manufactured.”
For example, during an inspection of two weeks of a drug factory in India which ended last September, the FDA inspectors observed an inadequate cleaning of the equipment, problems of air treatment systems (including bird excrement and feathers on air purification units) and 15 bags of waste containing torn quality registers, according to an agency alert letter March. The company, India Limited granules, did not respond to the request for NPR comments.
International trips take additional support
Licensed support employees used to manage plane trips, hotels and land transport – all for inspectors’ trips worldwide. “It was a full -time job for someone for a reason – it’s a ton of work,” said food and food inspector.
“It seems that it will slow down the ability of inspectors to do their job,” said Baker. “The quality of the inspections will inevitably decrease, which is a sad situation for public health. And I think that overall, patients who are the most vulnerable, who are generally young children and the elderly, will bear the consequences.”
International inspection trips generally last three weeks, involve several facilities and cost more than $ 10,000, the current inspectors and Baker at NPR told. Sometimes it is the cost of the plane ticket alone.
Wonderful trips take place on government credit cards in the names of the inspectors. If the government does not reimburse them quickly, the inspectors are worried about having to pay the stiff invoices themselves.
“It’s very stressful,” said Baker. “They will probably have to contract loans from family members or perhaps even a bank to be able to fulfill their obligations on these credit cards if these payments of expenditure reports are delayed.”
Uncertainty is a problem because the FDA was already short and has trouble attracting and keeping people who can earn more money in the private sector.
Chris Middendorf, who spent most of his more than two decades at the FDA as an inspector, said that if the inspectors had to spend at least a week to manage travel logistics themselves, it is time that they cannot write previous inspection reports, discover new technologies and prepare for their next inspection. “So everything will simply slow down the inspection process.”
Middendorf, who is now principal director of pharmaceutical and biotechnological compliance at the Hogan Lovells law firm, said that inspections in person remain the Order to ensure quality. With regard to drugs, the largest risk factor for contamination is human error.
“What you do not want to see are essentially operators who touch (their faces), playing with their mask by touching things with their hands, they should not be,” he said, explaining that these errors can cause bacteria to embark on sterile products. “But the only way to see them is to stand outside the production window and look for hours.”
