{"id":31917,"date":"2025-06-11T06:03:24","date_gmt":"2025-06-11T06:03:24","guid":{"rendered":"https:\/\/site.itshrt.com\/worldnews\/f-d-a-to-use-a-i-in-drug-approvals-to-radically-increase-efficiency\/"},"modified":"2025-06-11T06:03:24","modified_gmt":"2025-06-11T06:03:24","slug":"f-d-a-to-use-a-i-in-drug-approvals-to-radically-increase-efficiency","status":"publish","type":"post","link":"https:\/\/site.itshrt.com\/worldnews\/f-d-a-to-use-a-i-in-drug-approvals-to-radically-increase-efficiency\/","title":{"rendered":"F.D.A. to Use A.I. in Drug Approvals to \u2018Radically Increase Efficiency\u2019"},"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\">The Food and Drug Administration is planning to use artificial intelligence to \u201cradically increase efficiency\u201d in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Another initiative involves a review of chemicals and other \u201cconcerning ingredients\u201d that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cThe F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,\u201d Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the <a class=\"css-yywogo\" href=\"https:\/\/jamanetwork.com\/journals\/jama\/fullarticle\/10.1001\/jama.2025.10116\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">JAMA article<\/a>.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration\u2019s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.<\/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\">Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cI don\u2019t want to be dismissive of speeding reviews at the F.D.A.,\u201d said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. \u201cI think that there is great potential here, but I\u2019m not seeing the beef yet.\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">A major A.I. rollout closely follows the release of a report by Mr. Kennedy\u2019s MAHA Commission, which uses an acronym for Make America Healthy Again, that was found to be rife with references to scientific research <a class=\"css-yywogo\" href=\"https:\/\/www.nytimes.com\/2025\/05\/29\/well\/maha-report-citations.html\" title=\"\">apparently fabricated<\/a> by an artificial intelligence program.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">For some cases, the F.D.A. officials proposed speeding major drug approvals by requiring only one major study in patients rather than two, a practice the agency has used in recent years. The pandemic provided a precedent, they said, for accelerating the process. <\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cWe believe this is clear demonstration that rapid or instant reviews are possible,\u201d Drs. Makary and Prasad wrote.<\/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\">But Mr. Holland pointed out that during the pandemic, many staff members were transferred from routine duties, including overseas inspections of food or drug facilities, and reassigned to hasten critical Covid product reviews.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The agency was also better staffed. In recent months, the F.D.A. shed about 1,940 employees, reducing the work force to 8,000 from roughly 10,000.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Last week, the agency introduced Elsa, an artificial intelligence large-language model similar to ChatGPT. The F.D.A. said it could be used to prioritize which food or drug facilities to inspect, to describe side effects in drug safety summaries and to perform other basic product-review tasks. The F.D.A. officials wrote that A.I. held the promise to \u201cradically increase efficiency\u201d in examining as many as 500,000 pages submitted for approval decisions.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Current and former health officials said the A.I. tool was helpful but far from transformative. For one, the model limits the number of characters that can be reviewed, meaning it is unable to do some rote data analysis tasks. Its results must be checked carefully, so far saving little time.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Staff members said that the model was hallucinating, or producing false information. Employees can ask the Elsa model to summarize text or act as an expert in a particular field of medicine.<\/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\">Dr. Makary said the A.I. models were not being trained by data submitted by the drug or medical device industry.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">When it comes to food oversight, Drs. Makary and Prasad said there would be a renewed focus on \u201cour increasingly chemically manipulated diet,\u201d a goal embraced by Republicans and Democrats. \u201cFor all additives,\u201d the article said, \u201cthe benefit-to-harm balance must be re-evaluated.\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Although the Trump administration is seeking steep cuts in the F.D.A.\u2019s budget for the next fiscal year, the food division is expected to receive additional funds.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Others noted the fine line agency officials were walking, given Mr. Kennedy\u2019s complaints that the F.D.A. is too close to the drug industry and the Trump administration\u2019s business-friendly approach.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Drs. Makary and Prasad wrote that the F.D.A. must be \u201cpartners with industry\u201d while avoiding \u201ca cozy relationship that has characterized the agency in the past.\u201d<\/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\">Dr. Reshma Ramachandran, a director of the Yale Collaboration for Regulatory Rigor, Integrity and Transparency, pointed out that Drs. Makary and Prasad were going on a six-city, <a class=\"css-yywogo\" href=\"https:\/\/www.fda.gov\/industry\/ceo-forums-fda-listening-tour-engage-pharma-ceos\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">closed-door listening tour<\/a> to meet with chief executives of the drug industry.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cHow is this guarding the agency \u2018against a cozy relationship\u2019 with industry?\u201d she asked. The F.D.A. priorities \u201cread as though they\u2019re straight out of PhRMA\u2019s playbook,\u201d she said, referring to the trade group.<\/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\/06\/10\/health\/fda-drug-approvals-artificial-intelligence.html\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Food and Drug Administration is planning to use artificial intelligence to \u201cradically increase efficiency\u201d in deciding whether to approve<\/p>\n","protected":false},"author":1,"featured_media":31918,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[213,114,139,884,960,232,144,915,3670,3671,2503,7518,219,916,113,111,7519],"class_list":["post-31917","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health-2","tag-artificial-intelligence","tag-donald-j","tag-drugs-pharmaceuticals","tag-federal-budget-us","tag-food","tag-food-and-drug-administration","tag-health-and-human-services-department","tag-kennedy","tag-makary","tag-marty","tag-medical-devices","tag-prasad","tag-regulation-and-deregulation-of-industry","tag-robert-f-jr","tag-trump","tag-united-states-politics-and-government","tag-vinayak-k"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.2 - 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