{"id":2572344,"date":"2026-02-22T07:44:01","date_gmt":"2026-02-22T12:44:01","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/rfk-jr-s-fda-makes-big-decision-designed-to-get-new-drugs-to-americans-faster\/"},"modified":"2026-02-22T07:46:57","modified_gmt":"2026-02-22T12:46:57","slug":"rfk-jr-s-fda-makes-big-decision-designed-to-get-new-drugs-to-americans-faster","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/rfk-jr-s-fda-makes-big-decision-designed-to-get-new-drugs-to-americans-faster\/","title":{"rendered":"RFK Jr.&#8217;s FDA Makes Big Decision Designed to Get New Drugs to Americans Faster"},"content":{"rendered":"<aside class=\"mashsb-container mashsb-main mashsb-stretched\"><div class=\"mashsb-box\"><div class=\"mashsb-count mash-medium\" style=\"float:left\"><div class=\"counts mashsbcount\">28<\/div><span class=\"mashsb-sharetext\">SHARES<\/span><\/div><div class=\"mashsb-buttons\"><a class=\"mashicon-facebook mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fwww.conservativenewsdaily.net%2Fbreaking-news%2Frfk-jr-s-fda-makes-big-decision-designed-to-get-new-drugs-to-americans-faster%2F\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Facebook<\/span><\/a><a class=\"mashicon-twitter mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/twitter.com\/intent\/tweet?text=&amp;url=https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=2572344&amp;via=ConservNewsDly\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Twitter<\/span><\/a><a class=\"mashicon-subscribe mash-medium mash-nomargin mashsb-noshadow\" href=\"#\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Subscribe<\/span><\/a><div class=\"onoffswitch2 mash-medium mashsb-noshadow\" style=\"display:none\"><\/div><\/div>\n            <\/div>\n                <div style=\"clear:both\"><\/div><\/aside>\n            <!-- Share buttons by mashshare.net - Version: 4.0.47--><p>The FDA plans to drop its long-standing two-trial requirement for approving new drugs, adopting a default position that one rigorous study plus supporting evidence can be enough for clearance. FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad argued in the New England journal of Medicine that advances in biology and data have made single studies more reliable,and that reducing the number of required trials could speed access to medicines,especially for common diseases. They emphasize that this shift will not apply uniformly to all products, with vaccines and certain gene therapies often still needing more evidence. The move reflects a broader effort to cut bureaucracy and accelerate approvals, while critics caution that implementation will be crucial to <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/transplanted-lungs-potentially-spread-deadly-legionella-infection-to-organ-recipients-cdc-study\/\" title=\"CDC ...: Transplanted Lungs May Transmit Deadly Legionella Infection\">ensure patient safety<\/a>. Historically, the two-study rule dates to the 1960s, but regulators have increasingly accepted single trials for rare or deadly diseases, and about 60% of first-in-class drugs were approved based on a single study in recent years. Industry reaction is mixed, and the actual impact will depend on how the policy is implemented and how closely the supporting data is scrutinized.  <\/p>\n<p class=\"readmore\">\n    <button onclick=\"showReadMore()\" id=\"readmorebtn\">Read more&#8230;<\/button>\n<\/p>\n<hr id=\"line\">\n<span id=\"more\"><\/p>\n<p><?xml encoding=\"utf-8\" ?><?xml encoding=\"utf-8\" ?><?xml encoding=\"utf-8\" ?><?xml encoding=\"utf-8\" ?><?xml encoding=\"utf-8\" ?><?xml encoding=\"utf-8\" ?><?xml encoding=\"utf-8\" ?><?xml encoding=\"utf-8\" ?><?xml encoding=\"utf-8\" ?><?xml encoding=\"utf-8\" ?><?xml encoding=\"utf-8\" ?><?xml encoding=\"utf-8\" ?><?xml encoding=\"utf-8\" ?><?xml encoding=\"utf-8\" ?><?xml encoding=\"utf-8\" ?><?xml encoding=\"utf-8\" ?><?xml encoding=\"utf-8\" ?><\/p>\n<section> \t\t\t\t<script>console.log(\"ad slot (AC1)\")<\/script><script>console.log(\"ad slot (IC1)\")<\/script><script>console.log(\"ad slot (IC2)\")<\/script><script>console.log(\"ad slot (IC3)\")<\/script><script>console.log(\"ad slot (IC4)\")<\/script><script>console.log(\"ad slot (REP_0)\")<\/script><\/p>\n<p>WASHINGTON (AP) &mdash; The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, the latest change from Trump administration officials vowing to speed up the availability of certain medical products.<\/p>\n<p>Going forward, the FDA&rsquo;s &ldquo;default position&rdquo; will be to require one study for new drugs and other novel health products, FDA Commissioner Dr. Marty Makary and a top deputy, Dr. Vinay Prasad, wrote in a New England Journal of Medicine <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMsb2517623\">piece<\/a> published Wednesday.<\/p>\n<p>The announcement is the latest example of Makary and his team changing longstanding FDA standards and procedures with the goal of slashing bureaucracy and accelerating the availability of new medicines.<\/p>\n<p>Since arriving at the agency last April, Makary has launched a series of directives that he says will shorten FDA reviews, including mandating the use of artificial intelligence by staffers and offering one-month drug assessments for new medications that serve &ldquo;national interests.&rdquo;<\/p>\n<p>It contrasts with the FDA&rsquo;s more restrictive approach to other products, including vaccines.<\/p>\n<p> <script type=\"text\/javascript\"> \t\t\tif ( getCookie( \"ff_subbed\" ) ) { \t\t\t\tdocument.getElementById(\"anyclipvideo\").remove() \t\t\t} else { \t\t\t\tdocument.addEventListener(\"DOMContentLoaded\", function() { \t\t\t\t\tfunction loadAnyclip() { \t\t\t\t\t\tconst container=document.getElementById(\"anyclipvideo\"); 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\t\t\t\t\tobserveElement(paragraphToObserve); \t\t\t\t}); \t\t\t} \t\t<\/script> <\/p>\n<p>In their piece published Wednesday, Makary and Prasad state that dropping the two-trial requirement reflects modern advances that have made drug research &ldquo;increasingly precise and scientific.&rdquo;<\/p>\n<p>&ldquo;In this setting, overreliance on two trials no longer makes sense,&rdquo; they wrote. &ldquo;In 2026 there are powerful alternative ways to feel assured that our products help people live longer or better than requiring manufacturers to test them yet again.&rdquo;<\/p>\n<p>The FDA officials predicted the shift would lead to &ldquo;a surge in drug development.&rdquo;<\/p>\n<p>Dr. Janet Woodcock, the FDA&rsquo;s former drug director, said the change makes sense and reflects the FDA&rsquo;s decades-long move toward relying on one trial, combined with supporting evidence, for various life-threatening diseases, including cancer.<\/p>\n<p>&ldquo;The scientific point is well taken that as we move toward greater understanding of biology and disease we don&rsquo;t need to do two trials all the time,&rdquo; Woodcock, who led the FDA&rsquo;s drug center for about 20 years before retiring in 2024, said of the move.<\/p>\n<p>The two-study standard for drugs dates to the early 1960s, when Congress passed a law requiring the FDA to review data from &ldquo;adequate and well-controlled investigations&rdquo; before clearing new medications. For decades, the agency interpreted that requirement as meaning at least two studies, preferably with a large number of patients and significant follow-up time.<\/p>\n<p>The reason for requiring the second study was to confirm that the first trial&rsquo;s results weren&rsquo;t a fluke and could be reproduced.<\/p>\n<p>But beginning in the 1990s, the FDA increasingly began accepting single studies for the approval of treatments for rare or fatal diseases that companies often struggle to test in large numbers of patients.<\/p>\n<p>Over the last five years, roughly 60 percent of first-of<a href=\"https:\/\/amzn.to\/3YuVZYV\" >-a-kind drugs approved<\/a> each year have been cleared based on a single study. The shift reflects laws passed by Congress that directed regulators to be more flexible when reviewing drugs for serious or hard-to-treat conditions.<\/p>\n<p>Woodcock said the new policy announced Wednesday will mainly impact drugs for common diseases that previously weren&rsquo;t eligible for reduced testing standards.<\/p>\n<p>&ldquo;It&rsquo;s not the cancers and the rare diseases that will be affected by this,&rdquo; she noted. &ldquo;The agency has been approving those on a single trial already.&rdquo;<\/p>\n<p>The latest approach from FDA leadership contrasts with the agency&rsquo;s recent actions on vaccines, gene therapies, and other treatments.<\/p>\n<p>Last week, the FDA&rsquo;s vaccine division, headed by Prasad, refused to accept Moderna&rsquo;s application for a new mRNA flu shot, saying its clinical trial was insufficient. Then on Wednesday, the agency reversed course, saying it would review the vaccine after Moderna agreed to conduct an additional study in older people.<\/p>\n<p>Separately, Prasad has rejected a string of experimental gene therapies and biotech drugs, citing the need for additional studies or more definitive evidence. The trend has weighed on the stocks of many biotech companies and clashed with Makary&rsquo;s public statements promoting the speed and flexibility of the FDA&rsquo;s reviews.<\/p>\n<p>Woodcock said the drug industry will have to wait and see whether the FDA&rsquo;s approach to promising experimental therapies changes.<\/p>\n<p>&ldquo;Implementation will be everything,&rdquo; she said. &ldquo;Since the agency&rsquo;s approach is unclear, and the industry is already baffled, I don&rsquo;t think this adds any illumination.&rdquo;<\/p>\n<p>___<\/p>\n<p><em>The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute&rsquo;s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.<\/em><\/p>\n<p style=\"font-style: italic;\">The Western Journal has not reviewed this Associated Press story prior to publication. Therefore, it may contain editorial bias or may in some other way not meet our <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/harrison-ford-announces-end-of-iconic-character-i-need-to-sit-down-and-rest-a-little-bit\/\" title=\"Harrison Ford retires iconic character, needs rest.\">normal editorial standards<\/a>. It is provided to our readers as a service from The Western Journal.<\/p>\n<div style=\"position: relative;\">\n<div class=\"ff-fancy-header-container\"> \t\t\t \t<\/div>\n<div class=\"entry-submit-correction inner-content\">\n<div class=\"correction-form\">\n<form style=\"display: none;\">\n<div class=\"sc-name-field\"> \t\t\t\t\t\t<label>* Name<\/label> \t\t\t\t\t\t<br \/> \t\t\t\t\t\t<input type=\"text\" name=\"name\" required> \t\t\t\t\t<\/div>\n<div class=\"sc--field\"> \t\t\t\t\t\t<label>* <\/label> \t\t\t\t\t\t<br \/> \t\t\t\t\t\t<input type=\"text\" name=\"\" required> \t\t\t\t\t<\/div>\n<p> \t\t\t\t\t<label>* Message<\/label> \t\t\t\t\t<br \/> \t\t\t\t\t<textarea name=\"message\" required><\/textarea> \t\t\t\t\t \t\t\t\t\t<\/p>\n<div class=\"required-message\" style=\"display: none; padding-bottom: 15px;\">* All fields are required.<\/div>\n<p> \t\t\t\t\t<input type=\"submit\" value=\"Submit\" onclick=\"event.preventDefault(); firefly_sc();\"> \t\t\t\t\t \t\t\t\t\t<\/p>\n<div class=\"firefly-sc-confirm\" style=\"display: none;\">Success!<\/div>\n<\/p><\/form>\n<\/p><\/div>\n<\/p><\/div>\n<p> \t\t<script> \t\t\tfunction firefly_sc() { \t\t\t\tif( typeof window.captchaPublicKey==typeof undefined ){ \t\t\t\t\tconsole.error('window.captchaPublicKey is not defined'); \t\t\t\t} \t\t\t\tgrecaptcha.execute( window.captchaPublicKey, { action: 'submit_correction' } ).then( function( token ) { \t\t\t\t\tvar opts={ \t\t\t\t\t\taction:    'firefly_sc_submit', \t\t\t\t\t\tname:      document.querySelector( '.entry-submit-correction [name=\"name\"]' ).value, \t\t\t\t\t\t:     document.querySelector( '.entry-submit-correction [name=\"\"]' ).value, \t\t\t\t\t\tmessage:   document.querySelector( '.entry-submit-correction [name=\"message\"]' ).value, \t\t\t\t\t\tpost_id:   firefly_post_id, \t\t\t\t\t\tcap_token: token \t\t\t\t\t}  \t\t\t\t\tvar inputs=[ 'name', '', 'message' ];  \t\t\t\t\tfor( var i=0; i <inputs.length; i++ ) if( ! ( opts[inputs[i]]=document.querySelector( '.entry-submit-correction [name=\"' + inputs[i] + '\"]' ).value ) ) { \t\t\t\t\t\tdocument.querySelector( '.entry-submit-correction .required-message' ).style.display='block'; \t\t\t\t\t\treturn; \t\t\t\t\t}  \t\t\t\t\tdocument.querySelector( '.entry-submit-correction input[type=\"submit\"]' ).style.display='none'; \t\t\t\t\tdocument.querySelector( '.entry-submit-correction .firefly-sc-submitting-img' ).src=firefly_loading_gif_url; \t\t\t\t\tdocument.querySelector( '.entry-submit-correction .firefly-sc-submitting-img' ).style.display='inline-block';  \t\t\t\t\tconsole.log( 'ma subbing' );  \t\t\t\t\tif( firefly_post_id ) opts['post_id']=firefly_post_id;  \t\t\t\t\t\/* Send the data using post with element id name and name2*\/ \t\t\t\t\tvar posting=jQuery.post( firefly_ajax_url, opts );  \t\t\t\t\t\/* Alerts the results *\/ \t\t\t\t\tposting.done( function( response ) { \t\t\t\t\t\tif( response.success ) { \t\t\t\t\t\t\tconsole.log( response.data ); \t\t\t\t\t\t\tdocument.querySelector( '.entry-submit-correction .firefly-sc-submitting-img' ).style.display='none'; \t\t\t\t\t\t\tdocument.querySelector( '.entry-submit-correction .firefly-sc-confirm' ).style.display='block';  \t\t\t\t\t\t\tdataLayer.push( { 'event': 'submit-correction' } ); \t\t\t\t\t\t} \t\t\t\t\t}); \t\t\t\t}); \t\t\t} \t\t<\/script> \t     \t\t\t\t\t\t     \t\t\t\t\t<\/div>\n<p style=\"border: 1px solid #f5f5f5; padding: 16px;\">Advertise with The Western Journal and reach millions of highly engaged readers, while supporting our work. <a href=\"https:\/\/www.westernjournal.com\/advertise-us\/?wj_source=article\">Advertise Today<\/a>.<\/p>\n<p><script>console.log(\"ad slot (BA1)\")<\/script> \t\t<\/p>\n<div class=\"ff-fancy-header-container\"> \t\t\t \t<\/div>\n<\/section>\n<p><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Food and Drug Administration has said it will drop its long-standing rule that new drugs must be supported by two rigorous trials to win approval. Instead, the agency\u2019s default will be one solid study, with additional supporting evidence, for many new medications and other innovative health products. The announcement is laid out in a New England Journal of Medicine piece by FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, published Wednesday.<\/p>\n<p>This move is part of a broader effort under the current administration to speed up access to certain medical products by reducing what officials view as unnecessary bureaucracy. Since taking the helm last year, Makary has issued several orders aimed at shortening review times and broadening the use of tools like artificial intelligence, while proposing faster assessments for drugs deemed to serve national interests. The approach marks a shift from how the FDA has historically handled vaccines and other high-profile therapies.<\/p>\n<p>The two-trial standard traces back to the 1960s, when Congress required the FDA to rely on data from adequate and well-controlled studies before approving new drugs. For decades the agency interpreted that as requiring at least two trials, especially for drugs with large patient numbers and long follow-ups, to guard against a fluke result. Starting in the 1990s, however, the FDA increasingly approved treatments for rare or deadly diseases based on a single study when large trials were impractical. In the past five years, about six in ten first-of-a-kind drugs were cleared on a single study.<\/p>\n<p>Officials say the new policy will mostly affect drugs for more common diseases that previously didn\u2019t qualify for reduced testing. It is not expected to change approvals for cancers and the rarest diseases, which have already often been approved based on a single trial. Janet Woodcock, the FDA\u2019s former drug chief, agreed that as our understanding of biology and disease advances, two trials aren\u2019t always necessary.<\/p>\n<p>The FDA\u2019s shift appears to diverge from recent actions on vaccines, gene therapies, and other treatments. For instance, the agency recently rejected Moderna\u2019s application for a new mRNA flu shot due to insufficient data, then later said it would review the vaccine after Moderna agreed to an additional study in older adults. Separately, Vinay Prasad has repeatedly called for more data on experimental gene therapies and biotech drugs. Industry observers warn that implementation details will be crucial, and the overall impact remains to be seen.<\/p>\n<p>Note: This summary is based on coverage of the FDA announcement and related commentary<\/p>\n","protected":false},"author":1,"featured_media":2572345,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"https:\/\/www.westernjournal.com\/wp-content\/uploads\/2026\/02\/3ee7b78db88a49dfad0ab39f50424cdb-1-scaled-e1771536493541.jpg","fifu_image_alt":"","footnotes":""},"categories":[33651],"tags":[39633,60278,74301,8468,50401],"class_list":["post-2572344","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-the-western-journal","tag-american-healthcare","tag-drug-approvals","tag-expedited-drug-approvals","tag-fda","tag-rfk-jr-2"],"fifu_image_url":"https:\/\/www.westernjournal.com\/wp-content\/uploads\/2026\/02\/3ee7b78db88a49dfad0ab39f50424cdb-1-scaled-e1771536493541.jpg","_links":{"self":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2572344","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=2572344"}],"version-history":[{"count":3,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2572344\/revisions"}],"predecessor-version":[{"id":2572348,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2572344\/revisions\/2572348"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/2572345"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=2572344"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=2572344"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=2572344"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}