In recent years, the Food and Drug Administration has hired surgical robotics experts and pioneers in artificial intelligence. It scooped up food chemists, lab safe monitors and diabetes experts who helped create past needle stab wounds and test strip artefacts.
Agency roles are far away and opportunities to bring about change in the field in order to keep up with the demands of the public who are troubled by fierce advances in medical technology and additives such as food dyes. I invited him.
A single weekend mass shooting across the FDA has left much of that effort gone. For many, most perplexity was the firing of hundreds of people whose jobs were not funded by taxpayers. Their position was funded through a council-approved agreement that routes fees from the pharmaceutical, medical devices and tobacco industries to institutions.
This money, known as user fees, provides proper staffing for reviews of countless products. Although criticised by some, including the country's new health secretary, Robert F. Kennedy Jr., the country's new health secretary, industry funding is widely regarded as essential as an institutional corrupt force. They currently account for almost half of the agency's $7.2 billion budget.
The FDA is believed to have lost about 700 of its 18,000 employees, but some cuts hit small teams so deeply that staff could compromise the safety of some medical devices. I think there is.
Among the layoffs were scientists supported by fees to monitor whether they would pick up evolving pathogens, including those that cause avian flu and covid. They have created the safety of medical devices such as surgical staplers, new systems for diabetes control, and AI software programs that scan millions of MRIs and other images to detect cancer across the human eye. It hindered the team to evaluate. The cut also eliminated the position of employees who played a role in assessing the brain implant technology of Elon Murralink devices.
The layoffs affected so many key experts that the major medical device trade groups have called for the Trump administration to reconsider cutting jobs.
The layoffs included lawyers warning retailers about selling minor cigarettes, and scientists who studied the safety of e-cigarettes and the safety of new heat-free devices. The Tobacco Division is fully funded by excise tax on cigarettes – lost about 85 staff.
Dr. Robert Caliph, FDA commissioner under President Biden, said it appears that cuts of staff appear to be scattered. Dr. Caliph said the layoffs were effectively “anti-efficient” with the aim of not being so subtle about the government's efficiency, which is reducing Musk's government efficiency.
“These are not voluntary employment,” he said. “They're doing it to meet their needs.”
The lawsuit challenging the dismissal filed by the union, which includes those representing FDA employees, failed to stop the layoffs in a ruling issued Thursday. Other cuts have reduced staff of 2,000 members in the FDA's food sector. This is supported by tax.
Jim Jones, former director of the division who resigned from Cut on Monday, has spoken to Trump's transition team about Kennedy and his efforts to create a new office that reviews key targets on his agenda to make America. He said he explained. Health again: Food additives already on the market.
In an interview, nine of the 30 food chemical safety staff members left.
“They created real pickles for themselves,” Jones said. “You can't just give a free evaluation and you can't ban chemicals by Fiat.”
In interviews with 15 current and former agency staff members, the fired people are a group that includes agency veterans who have assumed a new role and have been promoted or hired for probation over the past two years. He said he was an employee.
The remaining people said they are trying to advance their research by picking up a looming review of medical devices on bulletproof methods to detect deadly bacteria during testing at food production sites.
The department reviewing new drugs, vaccines and gene therapy has largely been spared. Officials from the Department of Health and Human Services, the FDA's parent agency, did not respond to requests for comment.
FDA employees fired last weekend have uniformly spoken emails that their skills are not needed and their performance is “not enough to justify further employment by agents.” was notified in. However, many of them said their performance reviews exceeded expectations.
Tony Maiorana, 37, is working on product approval and safety in the rapidly changing field of diabetes devices. Over the past decade, the field has moved from painful needle stings and test strips to a system that measures glucose levels just below the skin and automatically injects the necessary insulin.
Reviewing new products can be laborious. The new algorithm measures and distributes insulin. Materials embedded in the body must avoid rejection by the immune system. Millions of patients, from young children to elderly people, are also at risk when their devices become dysfunctional.
Still, he said about half of Dr. Maiorana's product review team had been eliminated.
“If you're a patient and you complain, we're the people who will resolve your complaints,” he said. “We're going to monitor death reports. We're telling businesses. “Hey, there's a big pattern going on here. People are dying for your device or hospitals Are you almost dying?” and “What's changed? What's wrong?’”
Dr. Maiolana said he had expected government work to be “cold” but that turned out to be intense. His team had to assess whether research into new devices that have never been used in humans is safe for adults and children. They also had to watch online markets for diabetes technology that were not approved by agents.
“This is why the FDA was established – to protect the public,” Dr. Maiorana said.
Albert Yi, 59, a biomechanics and robotics expert, was fired Saturday. In his unit, four of the 11 staff members reviewing the safety of the surgical robot were let go.
Robotic surgery is increasingly adopted in operating rooms nationwide and is used in cardiothoracic, gynecological and obesity surgeries. Dr. Yee worked in the industry and academia before joining the FDA.
He said his team is extremely specialized, including a doctoral degree in medical robotics and a doctor who ran a robotics business.
He said that the diverse expertise of the team is important to assess not only the safety of such tools but also cybersecurity concerns as well as the safety of cybersecurity.
“If all of these devices are currently connected to the hospital network, they're either going into the hospital network or the device itself,” Dr. Yee said.
He said the team also announced a flood of applications for surgical equipment developed overseas. He said that extreme care must be taken to capture issues that could put patients at risk.
“The institutional knowledge we are losing is just horrifying,” he said. “I'm worried about public safety with this type of purge.”
Nathan Weidenhamer was a lead reviewer of cardiovascular devices and other high-risk implants.
He said he was shocked and disappointed that he and other reviewers in the devices division were partially funded by fees generated by the industry, and he was disappointed.
“I thought we were just important and important civil servants, and I'm spared,” he said.
The layoffs clearly did not skip employee slots created and funded by agreements negotiated with industry, legislators and FDA officials. The industry offers billions of dollars in return for staff equipped to meet strict deadlines for product approval decisions, but not all in the favor of the company. This money is also used to make the FDA a competitive employer in a specialist field that requires a high degree.
Some deadlines are considered demanding by FDA staff. In particular, the 30-day watch requires that you allow or add comments to research devices embedded in humans for the first time. If the institution does not respond within that time frame, the study will be given green light under the law.
The depth of medical device cuts to staff has prompted Advamed, the industry association of industry, to push back letters to top health and human service officials.
We explained in detail the reduction in the number of approximately 180 medical device staff. This includes a 20% reduction in 25 artificial intelligence experts, biostatisticians who evaluated research on new devices, and a loss of molecular biologists with expertise in diagnostic testing identifying cancer subtypes. Included. The layoffs also applied to senior officials who were recently adopted and were recently adopted to oversee around 10,000 product applications and meeting requests per year.
The group said it is grateful for the Trump administration's efforts to improve efficiency. But “they may have missed the mark on how they unfolded,” Advamed President Scott Whitaker said in an interview.
Medical device companies are profiting when the FDA has adequately placed people with expertise to guide the safe development of new technologies, he added.
“It's not good to be slow and over-adjusted,” he said. “Some of them lack resources and are not regulated at all. That's not good either.”
Alice Callahan contributed to the report.
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