{"id":31149,"date":"2025-06-17T23:00:58","date_gmt":"2025-06-17T23:00:58","guid":{"rendered":"https:\/\/financialrush.com\/?p=31149"},"modified":"2025-06-17T23:00:58","modified_gmt":"2025-06-17T23:00:58","slug":"fda-chief-seeks-to-soothe-us-biotech-fears-over-drug-approval-timeline","status":"publish","type":"post","link":"https:\/\/financialrush.com\/?p=31149","title":{"rendered":"FDA chief seeks to soothe US biotech fears over drug approval timeline"},"content":{"rendered":"<p> \n<\/p>\n<div>\n<p>Unlock the Editor\u2019s Digest for free<\/p>\n<p class=\"article__content-sign-up-topic-description o3-type-body-base\"><span>Roula Khalaf, Editor of the FT, selects her favourite stories in this weekly newsletter.<\/span><\/p>\n<p><iframe class=\"article__content-sign-up-iframe close\" scrolling=\"no\" id=\"signUpIframe\" data-prev-url=\"\/register\/in-article-sign-up?ft-content-uuid=ad98ff51-da9c-410f-8c7e-795f08ba2297\"><\/iframe><\/div>\n<div id=\"article-body\">\n<p>The head of the US Food and Drug Administration has sought to reassure biotechnology companies that drug approvals will not be delayed following the Trump administration\u2019s drastic workforce cuts, despite industry concerns that medicine approvals could be stuck in gridlock. <\/p>\n<p>\u201cWe are hiring scientists at the FDA,\u201d said Marty Makary, the agency\u2019s commissioner, speaking at a <a href=\"https:\/\/www.ft.com\/biotech\" data-trackable=\"link\">biotech<\/a> conference in Boston on Tuesday. \u201cI have reinstated people at the FDA.\u201d<\/p>\n<p>Makary, who was confirmed in late March, said \u201cit was a challenge\u201d for him to start work at the agency following the axing of staff by Elon Musk\u2019s so-called Department of Government Efficiency, but he said \u201cmorale is good and improving\u201d. While he said the people who were fired were support staffers, he acknowledged there were \u201ctremendous redundancies\u201d at the agency.<\/p>\n<p>However, the biotech community remains sceptical that the <a href=\"https:\/\/www.ft.com\/stream\/c76c7399-a454-4408-87fa-5ae31e5666f7\" data-trackable=\"link\">FDA<\/a> is running at full speed. \u201cThere have been a lot of delays across the industry [stemming from the FDA],\u201d Moderna chief executive St\u00e9phane Bancel said on June 11. Biotech company Solid Biosciences warned investors in May that \u201cdelays at the FDA\u201d could hurt its business.<\/p>\n<p>Biotech companies rely on the FDA to approve new medicines, and following President Donald Trump\u2019s inauguration, share prices have languished throughout the sector. The Nasdaq biotech index dropped after the FDA\u2019s top vaccine regulator Peter Marks abruptly resigned on March 28. The index is down 3 per cent for the year.\u00a0<\/p>\n<p>Vaccine makers like Moderna have been particularly hard hit since Trump took office. Health and human services secretary Robert F Kennedy Jr last week <a href=\"https:\/\/www.ft.com\/content\/ac991d13-a3c5-4cc3-b66f-1a848b52ac0d\" data-trackable=\"link\">fired all of a top vaccine committee panel<\/a> that makes recommendations to the government.<\/p>\n<p>The panel\u2019s first meeting with Kennedy\u2019s newly selected experts is scheduled for later this month, and it remains uncertain how hostile they might be to the US vaccine schedule.<\/p>\n<p>Makary said the FDA recommendations for Covid-19 vaccines \u201care moving closer to the European model\u201d, which are less aggressive than the US. In the UK, Covid vaccines were recommended for people 75 or older and individuals with high-risk health conditions, he said.<\/p>\n<p>The US, meanwhile, has recommended \u201cthat every 12-year-old healthy child in America needs another 60 doses for the rest of their life \u2014 one every year,\u201d Makary said. \u201c[That] is not supported with good clinical data for young, healthy people \u2014 the repeat booster strategy, in my personal opinion.\u201d<\/p>\n<p>Separately on Tuesday, the <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests\" data-trackable=\"link\">FDA announced<\/a> a programme to speed up drug development for certain medicines. The timeframe for review could be cut to 1-2 months from almost a year for these medicines, the FDA said. Although parts of the programme were already established, the announcement is likely to please those in the biotech industry.<\/p>\n<\/div>\n\n<br \/><a href=\"https:\/\/www.ft.com\/content\/ad98ff51-da9c-410f-8c7e-795f08ba2297\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"Unlock the Editor\u2019s Digest for free Roula Khalaf, Editor of the FT, selects her favourite stories in this&hellip;\n","protected":false},"author":5,"featured_media":31150,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[23],"tags":[],"class_list":["post-31149","post","type-post","status-publish","format-standard","has-post-thumbnail","category-us","cs-entry","cs-video-wrap"],"_links":{"self":[{"href":"https:\/\/financialrush.com\/index.php?rest_route=\/wp\/v2\/posts\/31149","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/financialrush.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/financialrush.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/financialrush.com\/index.php?rest_route=\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/financialrush.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=31149"}],"version-history":[{"count":0,"href":"https:\/\/financialrush.com\/index.php?rest_route=\/wp\/v2\/posts\/31149\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/financialrush.com\/index.php?rest_route=\/wp\/v2\/media\/31150"}],"wp:attachment":[{"href":"https:\/\/financialrush.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=31149"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/financialrush.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=31149"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/financialrush.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=31149"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}