{"id":7810,"date":"2025-02-21T17:30:35","date_gmt":"2025-02-21T17:30:35","guid":{"rendered":"https:\/\/site.itshrt.com\/worldnews\/firings-at-fda-decimated-teams-for-ai-and-food-safety-those-hires-are-now-gone\/"},"modified":"2025-02-21T17:30:35","modified_gmt":"2025-02-21T17:30:35","slug":"firings-at-fda-decimated-teams-for-ai-and-food-safety-those-hires-are-now-gone","status":"publish","type":"post","link":"https:\/\/site.itshrt.com\/worldnews\/firings-at-fda-decimated-teams-for-ai-and-food-safety-those-hires-are-now-gone\/","title":{"rendered":"Firings at FDA Decimated Teams for AI and Food Safety. Those Hires Are Now Gone."},"content":{"rendered":"<p> <script async src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-6606220950177433\"\r\n     crossorigin=\"anonymous\"><\/script>\r\n<!-- ItShrt World News -->\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block\"\r\n     data-ad-client=\"ca-pub-6606220950177433\"\r\n     data-ad-slot=\"1882483372\"\r\n     data-ad-format=\"auto\"\r\n     data-full-width-responsive=\"true\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\r\n<br \/>\n<\/p>\n<div data-testid=\"companionColumn-0\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Known as user fees, the money provides adequate staffing for reviews of myriad products. While <a class=\"css-yywogo\" href=\"https:\/\/www.nytimes.com\/2022\/09\/15\/health\/fda-drug-industry-fees.html\" title=\"\">criticized by some<\/a>, including the nation\u2019s 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\u2019s $7.2 billion budget.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-1\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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\u2019s Neuralink devices.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The layoffs affected so many key experts that a major medical device trade group has requested that the Trump administration reconsider the job cuts.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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 \u2014 which is fully funded by an excise tax on cigarettes \u2014 lost about 85 staff members.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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\u2019s Department of Government Efficiency, which is reducing the federal work force, Dr. Califf said the layoffs were, in effect, \u201canti-efficiency.\u201d<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-2\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">\u201cThese are not hires that are done arbitrarily,\u201d he said. \u201cThey\u2019re done to meet a need.\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">A lawsuit challenging the firings filed by unions, including one that represents some F.D.A. employees, failed to stop the layoffs in a <a class=\"css-yywogo\" href=\"https:\/\/www.nytimes.com\/2025\/02\/20\/us\/politics\/federal-worker-firings-trump-ruling.html\" title=\"\">ruling issued Thursday<\/a>. Other cutbacks reduced the 2,000-member staff of the F.D.A.\u2019s food division, which is supported by tax dollars.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Jim Jones, the former director of the division <a class=\"css-yywogo\" href=\"https:\/\/www.nytimes.com\/2025\/02\/18\/us\/politics\/fda-food-safety-jim-jones-resignation.html\" title=\"\">who resigned on Monday<\/a> 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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Nine people from that food-chemical-safety staff of 30 are gone, including specialized toxicologists and chemists, Mr. Jones said in an interview.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cThey\u2019ve created a real pickle for themselves,\u201d by cutting staff members working on a key priority, Mr. Jones said. \u201cYou just can\u2019t do an assessment for free and you can\u2019t ban chemicals by fiat.\u201d<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-3\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-4\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Divisions that review novel medications, vaccines and gene therapies were largely spared. Officials with the F.D.A.\u2019s parent agency, the Department of Health and Human Services, did not respond to requests for comment.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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 \u201cnot adequate to justify further employment by the agency.\u201d Yet many of them said that their performance reviews had said they exceeded expectations.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-5\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Still, about half of Dr. Maiorana\u2019s product-review team was eliminated, he said.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cIf you\u2019re a patient and you complain, we are the ones that field your complaints,\u201d he said. \u201cWe are the ones that monitor the death reports. We\u2019re the ones that are telling companies: \u2018Hey, there\u2019s a big pattern of error happening here. People are dying or ending up in the hospital because of your device\u2019 and \u2018What has changed? What happened?\u2019\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Dr. Maiorana said that he had expected his government job would be \u201cchill,\u201d 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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cThis is the reason the F.D.A. was founded \u2014 to protect the public,\u201d Dr. Maiorana said.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-6\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">He said his team was highly specialized, including an expert with a doctorate in medical robotics and a physician who had conducted robotic operations.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">He said that robotic devices had become so complex that the team\u2019s diverse expertise was critical to evaluate not just the safety of such tools but also concerns about cybersecurity.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cAll of these devices now \u2014 if they\u2019re attached to the hospital network, they become an avenue to get into the hospital network or get into the device itself,\u201d Dr. Yee said.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cThe institutional knowledge we\u2019re losing is just horrific,\u201d he said. \u201cI am concerned about public safety with this type of purge.\u201d<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-7\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">Nathan Weidenhamer was a lead reviewer of cardiovascular devices and other high-risk implants.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cI na\u00efvely thought we were important, critical public servants and I\u2019d be spared,\u201d he said.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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 \u2014 though not all go in companies\u2019 favor. The money is also used to make the F.D.A. a competitive employer in specialized fields that require advanced degrees.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-8\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The group said it appreciated the Trump administration\u2019s efforts to improve efficiency. But \u201cthey may have missed the mark on how they rolled it out,\u201d Scott Whitaker, the president of AdvaMed, said in an interview.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cOne that is slow and overregulates is not good,\u201d he said. \u201cOne that is under-resourced and doesn\u2019t regulate at all \u2014 that\u2019s not good either.\u201d<\/p>\n<p class=\"css-798hid etfikam0\">Alice Callahan<!-- --> contributed reporting.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<p><script async src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-6606220950177433\"\r\n     crossorigin=\"anonymous\"><\/script>\r\n<!-- ItShrt World News -->\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block\"\r\n     data-ad-client=\"ca-pub-6606220950177433\"\r\n     data-ad-slot=\"1882483372\"\r\n     data-ad-format=\"auto\"\r\n     data-full-width-responsive=\"true\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\r\n<br \/>\n<br \/><a href=\"https:\/\/www.nytimes.com\/2025\/02\/21\/health\/fda-trump-layoffs-device-and-food-safety.html\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In recent years, the Food and Drug Administration hired experts in surgical robots and pioneers in artificial intelligence. It scooped<\/p>\n","protected":false},"author":1,"featured_media":7811,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[38],"tags":[213,2906,929,114,960,232,235,144,1816,1035,915,1071,2503,364,219,916,2543,1756,626,113,111,2905],"class_list":["post-7810","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-science","tag-artificial-intelligence","tag-califf","tag-diabetes","tag-donald-j","tag-food","tag-food-and-drug-administration","tag-government-employees","tag-health-and-human-services-department","tag-hiring-and-promotion","tag-innovation","tag-kennedy","tag-layoffs-and-job-reductions","tag-medical-devices","tag-presidential-transition-us","tag-regulation-and-deregulation-of-industry","tag-robert-f-jr","tag-robert-m","tag-robots-and-robotics","tag-tests-medical","tag-trump","tag-united-states-politics-and-government","tag-wages-and-salaries"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Firings at FDA Decimated Teams for AI and Food Safety. Those Hires Are Now Gone. - World News<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/site.itshrt.com\/worldnews\/firings-at-fda-decimated-teams-for-ai-and-food-safety-those-hires-are-now-gone\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Firings at FDA Decimated Teams for AI and Food Safety. Those Hires Are Now Gone. - World News\" \/>\n<meta property=\"og:description\" content=\"In recent years, the Food and Drug Administration hired experts in surgical robots and pioneers in artificial intelligence. 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