Inspectors accused of drug conservation in America say they feel a large number of deep cuts on food and medicines, despite the promises of the Trump administration for the maintenance of the agency’s investigative forces.
Dozens of people who help coordinate trips to complex inspections of foreign drugs were released, and although some have since been re -inspectors, stated that the constant stress of the police industry, widespread in more than 90 countries, has exhausted employees and may endure the safety of medicines.
Over the years, inspectors have discovered dirty equipment, contaminated materials and false testing at some foreign factories – serious security and quality disorders that can ache or kill consumers. Last month, Propublica reportsWhat a genetic immunosuppression drug for patients with transplantation can dissolve too quickly when taken inward, increasing the risk of renal failure. Drugs were made at the Indian factory with the history of qualitative violations that were launched from the US market. The company has previously said Propublica that he believed that the medicine is safe.
In April more than 3500 FDA officers were fired as part of the US Ministry, as well as Robert F. Kennedy -Jellish, about 15% of the power decrease, as well as the Health and Human Services Secretary Robert. “We don’t just reduce the bureaucratic distribution. We rearrange the organization with its main mission and our new priorities in the abolition of the chronic illness epidemic,” – said Kennedy.
At the time, the agency said the reduction would not affect the inspectors. Since then, Kennedy has announced that HHS cancel 20% of the agency’s reduction. Among News reports Describing dismissal in the FDA, Kennedy did not specify how many people would be restored.
In recent weeks, Propublica has made a 10 -present FDA and former employees of the FDA, including inspectors who said the loss of support staff slowed down critical investigations and that little assistance had come true. Most refused to be called because they had no right to talk publicly or afraid of reactions in the field, looking for new jobs.
One of the veterans -the inspectors said that nearly 70 people were shot to organize trips, budgets, translators and emergency plans for investigations. Only about a third were returned, forcing several employed executives to coordinate checks and visas to check the weeks and include stops in several countries.
“It’s hard to check,” the investigator said. “The pace slowed down. You can’t inspect so many sites.”
In the email, the HHS press secretary said the inspection was not affected by the reduction. The agency did not consider the questions about how many people have been released or whether further assistance will be provided.
“To make it clear, the FDA inspectors were not injured, and this critical work is ongoing,” the agency said.
Two former FDA commissioners and long -standing drug heads of the agency said the loss of support staff undermined one of the most important FDA missions at a time when Americans receive most of their common drugs from foreign manufacturers. These include chemotherapy procedures, sedatives, antibiotics and medicines on hospital cracks.
“It’s like saying,” Oh, we didn’t focus any of the doctors and nurses at the hospital, but we fired all laboratory equipment, all the order, all the phlebotomes … Oh, but doctors and nurses are still left, so it’s normal, “said Janet Woodcock, who managed the drug center and more than two years. Things will be missing. “
In addition to reducing employees, the trips of some long -standing investigators and leaders have left less experienced people involved in the introduction of dangerous and sometimes deceptive production practices.
In the investigative department, which deals with potential security problems with drugs, vaccines, medical devices and other products, had problems with maintenance for years. Inspectors leave so often that even when the blitz is stitched, the FDA could not go forward.
Between 2022 and 2024, the agency hired 105 inspectors, but about 230 people left about 230, leaving the inspection pool, Office of Government accountabilityCongress observer.
About a third had no experience conducting independent foreign inspections, Gao revealed.
Two FDA inspectors said the agency requires additional 100 to 200 experienced investigators.
Work can be grueling. Some inspectors traveling to the overseas factories may be within 15 weeks a year. Some described the threats of violence by the heads of companies, days on planes and trains in depressing heat and long nights, preparing reports on inspection before they head to the next stop.
The loss of experienced investigators and the reduction to support employees also stolen other inspectors.
“I am in full shock that they do not support or promote those of us who can do a decent check,” said one investigator who studies the factories that produce vaccines, cell therapy and other biological products. “You add to chaos.”
Dozens of employees who supported technology, facilities, supplies and equipment were also rejected, leaving some daily operations in the agency. One current employee reminded how a colleague could not find a replacement batteries for a computer mouse and how one more closed from his office and could not return because there was no one to open the door.
Still before layoff, investigative force FDA fought for control Drug factories in countries that include India and China, especially during the COVID-19 pandemic pandemic, have a Congress’ signaling that serious production failures may have been left without control. The FDA received more than 1 million reports from doctors, patients and others in 2023 about product quality issues or consumers who had adverse drug reactions, FDA data shows.
“Things will be missed,” said former FDA inspector Patrick Stone about dismissal. “We will have much less safe drugs.”
In recent weeks Trump administration has said little about dismissal Kennedy said Congress At the end of last month, more than 900 staff of the Centers for Disease Control and Prevention and the National Institute of Health were restored.
Fda announced in May that it will expand the use of unproven inspections at foreign factories and it was some members of Congress push For years. And Commissioner FDA Marty Makari announced The fact that the new AI instrument known as the Alsha will help determine the goals of the inspection.
The current and former staff others say they do not replenish the loss.
“You can’t just expect that the inspector will take care of all the difficulties of organizing his trips abroad,” said former FDA commissioner Margaret Hamburg, which served in Obama administration. “Although we can say that we kept the inspectors, it does not mean that they have retained the infrastructure … which actually supports safe and significant checks.”
Brandon Roberts Data analysis is made.
