{"id":188065,"date":"2025-11-19T00:45:25","date_gmt":"2025-11-19T00:45:25","guid":{"rendered":"https:\/\/www.europesays.com\/ie\/188065\/"},"modified":"2025-11-19T00:45:25","modified_gmt":"2025-11-19T00:45:25","slug":"what-comes-after-the-fdas-drug-monopoly","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ie\/188065\/","title":{"rendered":"What Comes After the FDA\u2019s Drug Monopoly?"},"content":{"rendered":"<p data-type=\"paragraph\" data=\"[object Object]\" class=\"css-1akm6h5-Paragraph e1e4oisd0\">The FDA\u2019s monopoly over drug and device approval\u2014created by the 1938 Food, Drug, and Cosmetic Act and expanded by later amendments\u2014wasn\u2019t inevitable and is long overdue for reform (\u201cAdvice for Makary\u2019s FDA: Get Out of the Way,\u201d <a data-type=\"link\" href=\"https:\/\/www.wsj.com\/opinion\/advice-for-makarys-fda-get-out-of-the-way-pharma-drug-review-b6465516?mod=letterstoeditor_more_article_pos31&amp;mod=article_inline\" target=\"_blank\" class=\"ekxajjj0 css-i0lbhy-OverridedLink\" rel=\"nofollow noopener\">Letters<\/a>, Nov. 7). Before the government seized that authority, private organizations like the American Medical Association and the U.S. Pharmacopeia helped certify safety and effectiveness. These voluntary systems informed consumers without restricting access to care.<\/p>\n<p data-type=\"paragraph\" data=\"[object Object]\" class=\"css-1akm6h5-Paragraph e1e4oisd0\">The 1962 Kefauver-Harris Amendments, enacted after the thalidomide tragedy, required the agency to judge a drug\u2019s safety and effectiveness\u2014an expansion that has slowed innovation and delayed patients\u2019 access to lifesaving treatments. Today\u2019s \u201cdrug lag\u201d and \u201cdrug loss\u201d mean Americans wait years and pay billions more for medicines already available overseas.<\/p>\n<p>Copyright \u00a92025 Dow Jones &amp; Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8<\/p>\n","protected":false},"excerpt":{"rendered":"The FDA\u2019s monopoly over drug and device approval\u2014created by the 1938 Food, Drug, and Cosmetic Act and expanded&hellip;\n","protected":false},"author":2,"featured_media":188066,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[275],"tags":[105379,28610,41572,41573,105383,105380,41570,13782,49577,89492,41565,715,89493,105378,105381,13250,18,41571,3334,135,475,474,82483,19,41586,17,86819,3544,105382,40592,1539,2336,2856,2900,9436,44285,1143,1057,26243,384,41580],"class_list":{"0":"post-188065","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-healthcare","8":"tag-anti-competition-issues","9":"tag-bureaucracy","10":"tag-ce-executive-news-filter","11":"tag-ce-industry-news-filter","12":"tag-commentaries","13":"tag-commentaries-opinions","14":"tag-content-types","15":"tag-corporate","16":"tag-corporate-crime","17":"tag-corporate-crime-legal-action","18":"tag-corporate-industrial-news","19":"tag-crime","20":"tag-crime-legal-action","21":"tag-drug-approvals","22":"tag-editorials","23":"tag-efficacy","24":"tag-eire","25":"tag-factiva-filters","26":"tag-general-news","27":"tag-health","28":"tag-health-care","29":"tag-healthcare","30":"tag-healthcare-life-sciences","31":"tag-ie","32":"tag-industrial-news","33":"tag-ireland","34":"tag-legal-action","35":"tag-life-sciences","36":"tag-linki1-sb12640923844299794195604592481033015336726","37":"tag-monopoly","38":"tag-north-america","39":"tag-opinion","40":"tag-opinions","41":"tag-pharmaceuticals","42":"tag-political","43":"tag-political-general-news","44":"tag-reviews","45":"tag-safety","46":"tag-synd","47":"tag-united-states","48":"tag-wsj-pro-wsj-com"},"share_on_mastodon":{"url":"","error":"Validation failed: Text character limit of 500 exceeded"},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts\/188065","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/comments?post=188065"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts\/188065\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/media\/188066"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/media?parent=188065"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/categories?post=188065"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/tags?post=188065"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}