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Food and drug management teams (FDA


In recent years, the Food and Drug Administration has rented experts in surgical robots and pioneers in artificial intelligence. The food chemists, safety screens in laboratories and diabetes specialists who helped make needle tingling and testing tapes in the past.

In an attempt to keep pace with Breakneck’s progress in medical technology and the requirements of the turbulent audience by additions such as food dyes, the agency has seduced dozens of Midcareer specialists with distant roles and an opportunity to create teams in their fields.

At a weekend of the mass shooting via the FDA, a lot of this effort disappeared. Most of them were confusing to many in launching hundreds whose jobs were not funded by taxpayers. Their positions were funded by approved congress agreements that direct fees from drugs, medical devices and tobacco industries to the agency.

Money known as user fee is known, and provides countless products for product reviews. While some, including the new Minister of Health in the country, criticized Robert F. Kennedy Junior, as a corruption force on the agency, is seen widely seen as indispensable: it now represents half of the agency’s budget of $ 7.2 billion.

Although the FDA has lost about 700 of its 18,000 employees, some discounts hit a small difference so deeply that employees believe that the safety of some medical devices can be at risk.

Among the demobilization of workers, scientists were backed by fees that monitor whether the tests capture advanced pathogens, including those that cause bird flu and Covid. They have stumbled on the teams that establish the safety of medical devices such as surgical Staples, new systems to control diabetes, artificial intelligence programs that examine millions of magnetic resonance imaging and other images to detect cancer outside the human eye. The discounts also canceled the positions of employees who played a role in evaluating the technology of the brain hideout in the ELON Musk Neulink technology.

Workers’ layoffs affected many major experts to the point that the major medical devices trade group asked the Trump administration to review job reducing jobs.

The separation operations also included lawyers who warned retailers of tobacco sales under the legal age and scientists who studied electronic cigarette safety and new heat burning devices. The tobacco department – which is fully funded by the cigarette tax tax – has lost about 85 employees.

Dr. Robert Calif, Commissioner of FDA, said during the era of President Biden that employee discounts seemed scattered. Dr. Calif said that the inaccurate goals to the Ministry of Governmental efficiency of Mr. Musk, which reduces the federal workforce, said that the demobilization of workers in fact “combating efficiency.”

“These are not arbitrary recruits,” he said. “They have ended to meet the need.”

A lawsuit challenged the shootings filed by unions, including one representing some of the FDA employees, failed to stop the demobilization of workers in a ruling issued on Thursday. Other discounts reduced the employees of the 2000 members of the FDA Food Department, which is supported by tax dollars.

Jim Jones, the former director of the department that resigned on Monday due to the discounts, said that the Trump transitional team had informed his efforts to create a new office that would review a major goal for Mr. Kennedy and his agenda to make America healthy again: food additions already in the market.

In an interview, Mr. Jones said that nine people from the 30 -year -old food and chemical safety crew have been given, including specialized toxicists and specialized.

“They have created a real pickles for themselves,” said Mr. Jones, by cutting the employees working on a major priority. “You cannot make a free evaluation and you can not block chemicals by Fiat.”

In interviews with 15 current and former agency employees, they said that those who were demobilized were employees under observation, a group that included ancient veterans who took new roles, were recently promoted or appointed in the past two years.

Those who have been defending to capture reviews from medical devices and proceeding with studies to anti -bullets to detect fatal bacteria during inspections at food production sites.

Divides that decline new medicines, vaccines and genetics have been largely rescued. Officials at the Mother’s FDA, the Ministry of Health and Humanitarian Services, did not respond to requests for suspension.

The FDA employees that were launched at the end of last week were notified in unified email messages that their skills were not required and that their performance was “not enough to justify more employment by the agency.” However, many of them said that the reviews of their performance said that they had exceeded expectations.

Tony Mayoana, 37, a chemist, worked on the approval of the product and safety in the field of rapid diabetes. In the past decade, the field has moved from the painful needle and tested strips to systems that measure glucose levels directly below the skin and implant the required insulin automatically.

Working new products is strenuous: new algorithms that measure and distribute insulin; The substances cultivated in the body should be evaded by rejection by the immune system; Millions of patients from young children to the elderly are at risk if the devices are a malfunction.

However, approximately half of the Dr. Maueana products review team was canceled.

He said: “If you are sick and complain, we are the ones who fulfill your complaints.” We are monitoring death reports. We who tell companies: “Hey, there is a great pattern of error that happens here. People die or end up in the hospital because of your device” and “What has changed? What happened?”

Dr. Mayorana said he expected his government job to be “cold”, but it turned out to be intense. His team had to assess whether new devices studies that were not used in humans were safe for adults and children. They also had to see online markets of unaccounted diabetes technology by the agency.

“This is the reason for the establishment of the Food and Drug Administration – to protect the public,” said Dr. Mayorana.

Albert Yi, 59, was launched, an expert in biomedic mechanics and robots, on Saturday. In its unit, four of the 11 employees were abandoned, who are displaying the integrity of the surgical robots.

Mechanism operates increasingly in operating rooms throughout the country, and is used in surgeries for heart disease, gynecology and obesity treatment. Dr. Yi was working in industry and academic circles before joining FDA

He said his team was very specialized, including a doctoral expert in medical robots and a doctor who performed automatic operations.

He said that the automatic devices have become so complex that the various experience of the team was decisive in assessing not only the integrity of these tools but also concerns about cybersecurity.

“All these devices now – if they are linked to the hospital network, they become a way to enter the hospital network or enter the device itself,” said Dr. Yi.

He said that the team also presented a flood of surgical applications that were developed abroad and that were similar to those that companies made in the United States. He said that requests require close attention to problems that may endanger patients.

“The institutional knowledge we lose is terrible,” he said. “I am concerned about public safety with this type of cleansing.”

Nathan Weidharam was a major reviewer of cardiovascular and other highly dangerous transplants.

He said that he was shocked and disappointed because of his discharge because he and other auditors in the devices section were partially through the fees created by the industry.

He said: “I naively thought that we were important, public officials and I would have me.”

It is clear that the demobilization of the workers did not exceed the employees ’openings and the financing of the agreements that were negotiated with industries and legislators in the Congress and the officials of the Food and Drug Administration. Industries provide billions of dollars for employees equipped to fulfill the strict final dates for the decisions of approvals on the products – although they do not reach the benefit of companies. Money is also used to make FDA competitive employer in specialized fields that require advanced grades.

Some of the final dates are seen by the FDA employees as difficult, especially the 30 -day hour that requires them to delegate or add comments to studies on devices that are planted in humans for the first time. If the agency does not respond during this time frame, the study will be given a green light under the law.

The depth of discounts prompted the staff of ADVAMED, a commercial association for industry, to a return to a letter to the Supreme Health and Humanitarian Services Officer.

The letter detailed about 180 medical staff, which included 25 artificial intelligence experts, a 20 percent decrease in biologists who evaluated new devices studies and the loss of molecular biologists with experience in diagnostic tests that determine a sub -type of cancer. The shooting was also applied to a senior official who was recently recruited to oversee about 10,000 products for products and meetings annually.

The group said it appreciated the Trump administration’s efforts to improve efficiency. “Maybe the mark has been accused of how it was put up,” said Scott Whitaker, Advamed, in an interview.

He added that medical devices companies benefit when the Food and Drug Administration is well owned by people with experience to direct the safe development of new technology.

He said: “One is slow and organized not good.” “One is not desirable and is not organized at all-this is not good either.”

Alice Calman The reports contributed.

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