{"id":84497,"date":"2025-10-17T14:47:09","date_gmt":"2025-10-17T14:47:09","guid":{"rendered":"https:\/\/www.newsbeep.com\/nz\/84497\/"},"modified":"2025-10-17T14:47:09","modified_gmt":"2025-10-17T14:47:09","slug":"fda-unveils-drugs-to-receive-expedited-review-in-support-of-national-priorities","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/nz\/84497\/","title":{"rendered":"FDA unveils drugs to receive expedited review in support of &#8216;national priorities&#8217;"},"content":{"rendered":"<p class=\"dist__Box-sc-1fnzlkn-0 dist__TextBase-sc-1fnzlkn-3 bYFsJw cuqaEv article-text\">WASHINGTON \u2013 The <a href=\"https:\/\/apnews.com\/hub\/us-food-and-drug-administration\" rel=\"nofollow noopener\" target=\"_blank\">Food and Drug Administration<\/a> on Thursday announced the first round of experimental drugs that will receive <a href=\"https:\/\/apnews.com\/article\/fda-drugs-makary-trump-accelerated-approval-752146d97521b1644c9b10f2c6361f33\" rel=\"nofollow noopener\" target=\"_blank\">drastically expedited reviews<\/a> at the agency, part of an effort to prioritize medicines the Trump administration deems as \u201csupporting U.S. national interests.\u201d<\/p>\n<p class=\"dist__Box-sc-1fnzlkn-0 dist__TextBase-sc-1fnzlkn-3 bYFsJw cuqaEv article-text\">The nine medicines announced by the FDA include potential treatments for <a href=\"https:\/\/apnews.com\/article\/3065a5f655e14a19bd0369109b9dabdf\" rel=\"nofollow noopener\" target=\"_blank\">vaping addiction<\/a>, deafness, pancreatic cancer and other conditions. <\/p>\n<p class=\"dist__Box-sc-1fnzlkn-0 dist__TextBase-sc-1fnzlkn-3 bYFsJw cuqaEv article-text\">Several of the drugs would compete with higher-priced drugs already on the U.S. market.<\/p>\n<p class=\"dist__Box-sc-1fnzlkn-0 dist__TextBase-sc-1fnzlkn-3 bYFsJw cuqaEv article-text\">At the White House, <a href=\"https:\/\/apnews.com\/article\/trump-ivf-drug-fertility-2c168dcc0ec7250db16b0a671aea9db8\" rel=\"nofollow noopener\" target=\"_blank\">President Donald Trump<\/a> highlighted the injectable infertility drug, Pergoveris, which is currently sold in Europe for patients going through <a href=\"https:\/\/apnews.com\/article\/ivf-vitro-fertilization-trump-executive-order-65972cc1b10151bf1a0d9390fe5754d9\" rel=\"nofollow noopener\" target=\"_blank\">IVF treatments<\/a>. Trump said FDA approval of the drug in the U.S. would help lower IVF costs for American families, one of his campaign pledges.<\/p>\n<p class=\"dist__Box-sc-1fnzlkn-0 dist__TextBase-sc-1fnzlkn-3 bYFsJw cuqaEv article-text\">Another drugmaker received the specialty review to expand U.S. manufacturing of <a href=\"https:\/\/apnews.com\/article\/ketamine-pain-drugs-psychedelic-fda-2c67eeac1932962a7b0affc07d24c09a\" rel=\"nofollow noopener\" target=\"_blank\">ketamine<\/a>, the powerful anesthetic that has grown into a trendy <a href=\"https:\/\/apnews.com\/article\/matthew-perry-death-cause-054e67f7495845804f801c57a1ae2522\" rel=\"nofollow noopener\" target=\"_blank\">psychedelic treatment.<\/a><\/p>\n<p class=\"dist__Box-sc-1fnzlkn-0 dist__TextBase-sc-1fnzlkn-3 bYFsJw cuqaEv article-text\">Under the program announced earlier this year, the FDA will aim to decide whether to approve the drugs in one to two months, an unprecedented pace for the in-depth safety and effectiveness reviews performed by agency scientists.<\/p>\n<p class=\"dist__Box-sc-1fnzlkn-0 dist__TextBase-sc-1fnzlkn-3 bYFsJw cuqaEv article-text\">FDA\u2019s accelerated approval program generally issues decisions in six months for drugs that treat <a href=\"https:\/\/apnews.com\/article\/health-cancer-business-congress-drug-approvals-e029b9f3f72b4282ad39d2d00902edfe\" rel=\"nofollow noopener\" target=\"_blank\">life-threatening diseases<\/a>. Regular drug reviews take about 10 months.<\/p>\n<p class=\"dist__Box-sc-1fnzlkn-0 dist__TextBase-sc-1fnzlkn-3 bYFsJw cuqaEv article-text\">Since arriving at the agency, <a href=\"https:\/\/apnews.com\/article\/fda-trump-makary-vaccines-ultraprocessed-food-safety-ce9df8eb4bba5c950e500c62d975afe2\" rel=\"nofollow noopener\" target=\"_blank\">FDA Commissioner Dr. Marty Makary<\/a> has suggested the agency could dramatically speed up approvals for certain high-priority drugs, pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed.<\/p>\n<p class=\"dist__Box-sc-1fnzlkn-0 dist__TextBase-sc-1fnzlkn-3 bYFsJw cuqaEv article-text\">Many aspects of the so-called <a href=\"https:\/\/www.fda.gov\/industry\/commissioners-national-priority-voucher-cnpv-pilot-program\" rel=\"nofollow noopener\" target=\"_blank\">Commissioner&#8217;s National Priority Voucher<\/a> program overlap with older FDA programs. But the broad criteria for awarding the vouchers gives Makary and other FDA officials unprecedented discretion in deciding which companies will benefit from the sped-up reviews.<\/p>\n<p class=\"dist__Box-sc-1fnzlkn-0 dist__TextBase-sc-1fnzlkn-3 bYFsJw cuqaEv article-text\">___<\/p>\n<p class=\"dist__Box-sc-1fnzlkn-0 dist__TextBase-sc-1fnzlkn-3 bYFsJw cuqaEv article-text\">The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute\u2019s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.<\/p>\n<p>Copyright 2025 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission.<\/p>\n","protected":false},"excerpt":{"rendered":"WASHINGTON \u2013 The Food and Drug Administration on Thursday announced the first round of experimental drugs that will&hellip;\n","protected":false},"author":2,"featured_media":84498,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[65,134,524,111,139,69,28083],"class_list":{"0":"post-84497","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-donald-trump","9":"tag-health","10":"tag-medication","11":"tag-new-zealand","12":"tag-newzealand","13":"tag-nz","14":"tag-washington-news"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/posts\/84497","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/comments?post=84497"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/posts\/84497\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/media\/84498"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/media?parent=84497"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/categories?post=84497"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/tags?post=84497"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}