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Firings at FDA Decimated Teams Reviewing AI and Food Safety

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Firings at FDA Decimated Teams Reviewing AI and Food Safety

In recent years, the Food and Drug Administration hired experts in surgical robots and pioneers in artificial intelligence. It scooped up food chemists, lab-safety monitors and diabetes specialists who helped make needle pricks and test strips relics of the past.

Trying to keep up with breakneck advances in medical technology and the demands of a public troubled by additives like food dyes, the agency enticed scores of midcareer specialists with remote roles and the chance to make a difference in their fields.

In one weekend of mass firings across the F.D.A., much of that effort was gone. Most baffling to many were the firings of hundreds whose jobs were not funded by taxpayers. Their positions were financed through congressionally approved agreements that routed fees from the drug, medical device and tobacco industries to the agency.

Known as user fees, the money provides adequate staffing for reviews of myriad products. While criticized by some, including the nation’s new health secretary, Robert F. Kennedy Jr., as a corrupting force on the agency, the industry funds are also widely viewed as indispensable: They now account for nearly half of the agency’s $7.2 billion budget.

Though the F.D.A. is believed to have lost about 700 of its 18,000 employees, some cuts hit small teams so deeply that staff members believe the safety of some medical devices could be compromised.

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Among the layoffs were scientists supported by the fees who monitor whether tests pick up ever-evolving pathogens, including those that cause bird flu and Covid. They hobbled teams that evaluate the safety of medical devices like surgical staplers, new systems for diabetes control and A.I. software programs that scan millions of M.R.I.s and other images to detect cancer beyond the human eye. The cuts also eliminated positions for employees who have played a role in assessing the brain-implant technology in Elon Musk’s Neuralink devices.

The layoffs affected so many key experts that a major medical device trade group has requested that the Trump administration reconsider the job cuts.

The dismissals also included lawyers who warned retailers about underage tobacco sales and scientists who studied the safety of e-cigarettes and new heat-not-burn devices. The tobacco division — which is fully funded by an excise tax on cigarettes — lost about 85 staff members.

Dr. Robert Califf, the F.D.A. commissioner under President Biden, said the personnel cutbacks seemed scattershot. Taking a not-so-subtle aim at Mr. Musk’s Department of Government Efficiency, which is reducing the federal work force, Dr. Califf said the layoffs were, in effect, “anti-efficiency.”

“These are not hires that are done arbitrarily,” he said. “They’re done to meet a need.”

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A lawsuit challenging the firings filed by unions, including one that represents some F.D.A. employees, failed to stop the layoffs in a ruling issued Thursday. Other cutbacks reduced the 2,000-member staff of the F.D.A.’s food division, which is supported by tax dollars.

Jim Jones, the former director of the division who resigned on Monday over the cuts, said that he had briefed the Trump transition team on his efforts to create a new office that would review a premier target of Mr. Kennedy and his agenda to Make America Healthy Again: food additives that are already on the market.

Nine people from that food-chemical-safety staff of 30 are gone, including specialized toxicologists and chemists, Mr. Jones said in an interview.

“They’ve created a real pickle for themselves,” by cutting staff members working on a key priority, Mr. Jones said. “You just can’t do an assessment for free and you can’t ban chemicals by fiat.”

In interviews with 15 current and former agency staff members, they said those who were laid off had been probationary employees, a group that included agency veterans who took on new roles, were recently promoted or were hired in the last two years.

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Those who remained said that they had been scrambling to pick up pressing medical device reviews and move forward with studies to bulletproof methods for detecting deadly bacteria during inspections at food production sites.

Divisions that review novel medications, vaccines and gene therapies were largely spared. Officials with the F.D.A.’s parent agency, the Department of Health and Human Services, did not respond to requests for comment.

The F.D.A. employees fired last weekend were notified in uniformly worded emails that their skills were not needed and that their performance was “not adequate to justify further employment by the agency.” Yet many of them said that their performance reviews had said they exceeded expectations.

Tony Maiorana, 37, a chemist, worked on product approval and safety in the fast-changing field of diabetes devices. In the last decade, the field has moved from painful needle pricks and test strips to systems that measure glucose levels just below the skin and automatically infuse the needed insulin.

The work of reviewing new products is painstaking: Novel algorithms measure and dispense insulin; materials implanted in the body must evade rejection by the immune system; and millions of patients from toddlers to the elderly are at risk if devices malfunction.

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Still, about half of Dr. Maiorana’s product-review team was eliminated, he said.

“If you’re a patient and you complain, we are the ones that field your complaints,” he said. “We are the ones that monitor the death reports. We’re the ones that are telling companies: ‘Hey, there’s a big pattern of error happening here. People are dying or ending up in the hospital because of your device’ and ‘What has changed? What happened?’”

Dr. Maiorana said that he had expected his government job would be “chill,” but it turned out to be intense. His team had to assess whether studies of new devices that had never been used in humans were safe for adults and children. They also had to watch online marketplaces for diabetes technology that had not been approved by the agency.

“This is the reason the F.D.A. was founded — to protect the public,” Dr. Maiorana said.

Albert Yee, 59, an expert in biomechanics and robotics, was fired on Saturday. In his unit, four of 11 staff members, who review the safety of surgical robots, were let go.

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Robotic surgery is increasingly employed in operating rooms across the country, used in cardiothoracic, gynecological and bariatric surgeries. Dr. Yee had worked in the industry and in academia before joining the F.D.A.

He said his team was highly specialized, including an expert with a doctorate in medical robotics and a physician who had conducted robotic operations.

He said that robotic devices had become so complex that the team’s diverse expertise was critical to evaluate not just the safety of such tools but also concerns about cybersecurity.

“All of these devices now — if they’re attached to the hospital network, they become an avenue to get into the hospital network or get into the device itself,” Dr. Yee said.

He said the team also fielded a flood of applications for surgical apparatus developed abroad that were similar to those made by companies based in the United States. He said the applications required close attention to catch problems that could endanger patients.

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“The institutional knowledge we’re losing is just horrific,” he said. “I am concerned 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 to be laid off because he and other reviewers in the device division were partly funded by industry-generated fees.

“I naïvely thought we were important, critical public servants and I’d be spared,” he said.

The layoffs clearly did not skip over employee slots created and funded by the agreements negotiated with the industries, congressional lawmakers and F.D.A. officials. The industries provide billions of dollars in return for staff equipped to meet strict deadlines for decisions on product approvals — though not all go in companies’ favor. The money is also used to make the F.D.A. a competitive employer in specialized fields that require advanced degrees.

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Some of the deadlines are viewed by F.D.A. staff members as demanding, particularly the 30-day clock requiring them to authorize or add comments to studies of devices that are being implanted in humans for the first time. If the agency does not respond within that time-frame, the study is given a green light under the law.

The depth of cuts to medical device staff prompted AdvaMed, a trade association for the industry, to push back in a letter to a top Health and Human Services official.

The letter detailed about 180 medical device staff cuts, which included 25 experts in artificial intelligence, a 20 percent reduction in biostatisticians who evaluated studies of novel devices and the loss of molecular biologists with expertise in diagnostic tests that pinpoint a cancer subtype. The firings also applied to a top official who was recently recruited to oversee about 10,000 product applications and meeting requests per year.

The group said it appreciated the Trump administration’s efforts to improve efficiency. But “they may have missed the mark on how they rolled it out,” Scott Whitaker, the president of AdvaMed, said in an interview.

Medical device companies benefit when the F.D.A. is well staffed with people who have the expertise to guide the safe development of new technology, he added.

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“One that is slow and overregulates is not good,” he said. “One that is under-resourced and doesn’t regulate at all — that’s not good either.”

Alice Callahan contributed reporting.

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Experts Call It 2026’s Best Diet— ‘The Results Are Often Stunning’

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Experts Call It 2026’s Best Diet— ‘The Results Are Often Stunning’


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Deadly ‘superbug’ is spreading across US as drug resistance grows, researchers warn

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Deadly ‘superbug’ is spreading across US as drug resistance grows, researchers warn

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A deadly, drug-resistant fungus already spreading rapidly through U.S. hospitals is becoming even more threatening worldwide, though there may be hope for new treatments, according to a new scientific review.

Candida auris (C. auris), often described as a “superbug fungus,” is spreading globally and increasingly resisting human immune systems, Hackensack Meridian Center for Discovery and Innovation (CDI) researchers said in a review published in early December.

The findings reinforce prior CDC warnings that have labeled C. auris an “urgent antimicrobial threat” — the first fungal pathogen to receive that designation — as U.S. cases have surged, particularly in hospitals and long-term care centers.

DANGEROUS SPIKE IN SUPERBUG INFECTIONS SURGES ACROSS US AS EXPERTS SHARE CAUTIONS

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Approximately 7,000 cases were identified across dozens of U.S. states in 2025, according to the CDC, and it has reportedly been identified in at least 60 countries.

Candida auris is a drug-resistant fungus spreading in hospitals worldwide. (Nicolas Armer/Picture Alliance via Getty Images)

The review, published in Microbiology and Molecular Biology Reviews, helps explain why the pathogen is so difficult to contain and warns that outdated diagnostics and limited treatments lag behind. It was conducted by Dr. Neeraj Chauhan of the Hackensack Meridian CDI in New Jersey, Dr. Anuradha Chowdhary of the University of Delhi’s Medical Mycology Unit and Dr. Michail Lionakis, chief of the clinical mycology program at the National Institutes of Health.

Their findings stress the need to develop “novel antifungal agents with broad-spectrum activity against human fungal pathogens, to improve diagnostic tests and to develop immune- and vaccine-based adjunct modalities for the treatment of high-risk patients,” the researchers said in a statement.

GROWING ANTIBIOTIC CRISIS COULD TURN BACTERIAL INFECTIONS DEADLY, EXPERTS WARN

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“In addition, future efforts should focus on raising awareness about fungal disease through developing better surveillance mechanisms, especially in resource-poor countries,” they added. “All these developments should help improve the outcomes and prognosis of patients afflicted by opportunistic fungal infections.”

Candida auris can survive on skin and hospital surfaces, allowing it to spread easily. (iStock)

First identified in 2009 from a patient’s ear sample in Japan, C. auris has since spread to dozens of countries, including the U.S., where outbreaks have forced some hospital intensive care units to shut down, according to the researchers.

The fungus poses the greatest risk to people who are already critically ill, particularly those on ventilators or with weakened immune systems. Once infected, about half of patients may die, according to some estimates.

FLU BY STATE: WHERE THIS SEASON’S HIGHLY CONTAGIOUS VARIANT IS SPREADING THE MOST

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Unlike many other fungi, C. auris can survive on human skin and cling to hospital surfaces and medical equipment, allowing it to spread easily in healthcare settings.

“It is resistant to multiple antifungal drugs, and it tends to spread in hospital settings, including on equipment being used on immunocompromised and semi-immunocompromised patients, such as ventilators and catheters,” Dr. Marc Siegel, Fox News senior medical analyst and clinical professor of medicine at NYU Langone, previously told Fox News Digital.

Scientists say the unique cell wall structure of C. auris makes it harder to kill. (iStock)

It is also frequently misdiagnosed, delaying treatment and infection control measures.

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“Unfortunately, symptoms such as fever, chills and aches may be ubiquitous, and it can be mistaken for other infections,” Siegel said.

In September, he said intense research was ongoing to develop new treatments.

Only four major classes of antifungal drugs are currently available, and C. auris has already shown resistance to many of them. While three new antifungal drugs have been approved or are in late-stage trials, researchers warn that drug development has struggled to keep pace with the fungus’s evolution.

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Despite the sobering findings, there is still room for cautious optimism.

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The fungus can cling to skin and hospital surfaces, aiding its spread. (iStock)

In separate research published in December, scientists at the University of Exeter in England discovered a potential weakness in C. auris while studying the fungus in a living-host model. 

The team found that, during infection, the fungus activates specific genes to scavenge iron, a nutrient it needs to survive, according to their paper, published in the Nature portfolio journal Communications Biology in December.

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Because iron is essential for the pathogen, researchers believe drugs that block this process could eventually stop infections or even allow existing medications to be repurposed.

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“We think our research may have revealed an Achilles’ heel in this lethal pathogen during active infection,” Dr. Hugh Gifford, a clinical lecturer at the University of Exeter and co-author of the study, said in a statement.

New research is underway to develop better treatments and diagnostics for C. auris. (iStock)

As researchers race to better understand the fungus, officials warn that strict infection control, rapid detection and continued investment in new treatments remain critical.

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Health experts emphasize that C. auris is not a threat to healthy people.

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Fox News Digital has reached out to the CDI researchers and additional experts for comment.

Fox News Digital’s Angelica Stabile contributed reporting.

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Record-breaking flu numbers reported in New York state, sparking warnings from officials

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Record-breaking flu numbers reported in New York state, sparking warnings from officials

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The New York State Department of Health reported a record surge in influenza activity, with 71,123 positive flu cases recorded statewide during the week ending December 20.

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Health officials said the figure represents the highest number of flu cases ever reported in a single week since influenza became a reportable disease in New York in 2004.

State health data show the weekly total reflects a 38% increase from the previous reporting period, signaling a rapidly intensifying flu season.

There have been 189,312 reported positive flu cases so far this season, while influenza-related hospitalizations rose 63% in the most recent week.

FLU BY STATE: WHERE THIS SEASON’S HIGHLY CONTAGIOUS VARIANT IS SPREADING THE MOST

New York reported the highest weekly total of cases ever recorded since influenza became reportable in 2004. (iStock)

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“We are seeing the highest number of flu cases ever recorded in a single week in New York state,” Health Commissioner Dr. James McDonald said in a press release.

There have been 189,312 reported flu cases so far this season, with influenza-related hospitalizations increasing 63% in the most recent week. (iStock)

Earlier this month, the department declared influenza prevalent statewide, a designation that requires unvaccinated health care workers to wear masks in patient care settings.

SURGE IN WHOOPING COUGH CASES IN SOUTHERN STATE PROMPTS HEALTH ALERTS

Health officials continue to emphasize that vaccination remains the most effective way to prevent severe illness and hospitalization from influenza.

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New Yorkers who have not yet received a seasonal flu shot are still encouraged to do so, with experts saying vaccination can offer protection even later in the season.

Health officials continue to urge New Yorkers to take preventive steps, including vaccination and staying home when sick, to limit further spread. (iStock)

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To help limit further spread, the department advises individuals experiencing flu-like symptoms — including fever, cough, sore throat, or body aches — to stay home. State health officials also recommend frequent handwashing, using hand sanitizer, and avoiding close contact with sick individuals.

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For those who become ill, officials say antiviral medications are available and are most effective when started within 48 hours of symptom onset.

Health officials also added that people at higher risk for complications should contact a health care provider promptly for evaluation and possible treatment.

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The department noted that flu activity typically peaks in January, meaning case counts could continue to climb in the weeks ahead.

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