{"id":17806,"date":"2026-05-21T16:13:21","date_gmt":"2026-05-21T16:13:21","guid":{"rendered":"https:\/\/www.europesays.com\/france\/17806\/"},"modified":"2026-05-21T16:13:21","modified_gmt":"2026-05-21T16:13:21","slug":"sanofi-seeks-to-pull-drug-from-makary-fda-speedy-review-program","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/france\/17806\/","title":{"rendered":"Sanofi seeks to pull drug from Makary FDA speedy review program"},"content":{"rendered":"<p class=\"author-bio\">Lizzy leads STAT\u2019s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency\u2019s ability to protect and promote public health. Confidential tips can be sent on Signal at lizzylaw.53.<\/p>\n<p>WASHINGTON \u2014 Sanofi has asked the Food and Drug Administration to pull its type 1 diabetes drug, teplizumab, out of Commissioner Marty Makary\u2019s new speedy drug review program.\u00a0<\/p>\n<p>The move comes after acting Center for Drug Evaluation and Research Director Tracy Beth H\u00f8eg disagreed with a staff decision to approve the drug, according to sources familiar with the dispute who requested anonymity due to fear of reprisal. The agency has missed its goal date of April 21 to deliver a decision to Sanofi.<\/p>\n<p>Such decisions are typically made by career scientists. It\u2019s rare for a center director to become involved in scientific review of a single drug, and particularly a political appointee like H\u00f8eg. Makary <a href=\"https:\/\/www.cnbc.com\/2026\/05\/05\/fda-commissioner-marty-makary-defends-himself-under-pressure-.html\" target=\"_blank\" rel=\"noopener nofollow\">recently told CNBC<\/a> that he stands behind review teams, and that \u201cdisaster\u201d occurs whenever political leaders overrule scientific staff.\u00a0<\/p>\n<p class=\"restricted-text\">STAT+ Exclusive Story<\/p>\n<p class=\"restricted-login\">Already have an account? <a href=\"https:\/\/www.statnews.com\/login\/\" data-stat-login=\"\" data-stat-paywall-cta=\"breaker login cta\" rel=\"nofollow noopener\" target=\"_blank\">Log in<\/a><\/p>\n<p>\t\t\t<img decoding=\"async\" class=\"restricted-content-breaker-bg\" src=\"https:\/\/www.europesays.com\/france\/wp-content\/uploads\/2026\/05\/stat-plus-breaker-bg.png\" alt=\"STAT+\"\/><\/p>\n<p>\t\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" rel=\"nofollow noopener\" target=\"_blank\"><br \/>\n\t\t\t\t\t\t<img decoding=\"async\" class=\"stat-plus-logo\" src=\"https:\/\/www.statnews.com\/wp-content\/themes\/stat\/images\/stat-plus-logo-white.svg\" alt=\"STAT+\"\/><br \/>\n\t\t\t\t\t<\/a><\/p>\n<p>\t\t\t\tThis article is exclusive to STAT+ subscribers<br \/>\n\t\t\t\tUnlock this article \u2014 plus in-depth analysis, newsletters, premium events, and news alerts.<\/p>\n<p class=\"restricted-content-breaker-wrapper-cta mobile\">Already have an account? <a href=\"https:\/\/www.statnews.com\/login\/\" data-stat-login=\"\" data-stat-paywall-cta=\"breaker login cta mobile\" rel=\"nofollow noopener\" target=\"_blank\">Log in<\/a><\/p>\n<p>\t\t\t\t\t\tIndividual plans<\/p>\n<p>\t\t\t\t\t\tGroup plans<\/p>\n<p>\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" class=\"stat-button view-all\" data-stat-paywall-cta=\"breaker view all plans\" aria-label=\"View All Plans\" rel=\"nofollow noopener\" target=\"_blank\">View All Plans<\/a><\/p>\n<p class=\"restricted-content-text\">\n\t\t\t\t\t\tTo read the rest of this story subscribe to STAT+.\t\t\t\t\t<\/p>\n<p>\t\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" class=\"stat-button restricted-button\" data-stat-paywall-cta=\"breaker subscribe cta 1\" rel=\"nofollow noopener\" target=\"_blank\">Subscribe<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"Lizzy leads STAT\u2019s coverage of the FDA. Her stories explore the relationship between politics and science at the&hellip;\n","protected":false},"author":2,"featured_media":17807,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[12983],"tags":[13376,13377,13012,13378],"class_list":["post-17806","post","type-post","status-publish","format-standard","has-post-thumbnail","category-sanofi","tag-diabetes","tag-fda","tag-sanofi","tag-stat"],"_links":{"self":[{"href":"https:\/\/www.europesays.com\/france\/wp-json\/wp\/v2\/posts\/17806","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/france\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/france\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/france\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/france\/wp-json\/wp\/v2\/comments?post=17806"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/france\/wp-json\/wp\/v2\/posts\/17806\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/france\/wp-json\/wp\/v2\/media\/17807"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/france\/wp-json\/wp\/v2\/media?parent=17806"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/france\/wp-json\/wp\/v2\/categories?post=17806"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/france\/wp-json\/wp\/v2\/tags?post=17806"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}