{"id":569309,"date":"2023-04-08T04:38:48","date_gmt":"2023-04-08T01:38:48","guid":{"rendered":"https:\/\/en.buradabiliyorum.com\/judge-suspends-fda-approval-of-mifepristone\/"},"modified":"2023-04-08T04:38:48","modified_gmt":"2023-04-08T01:38:48","slug":"judge-suspends-fda-approval-of-mifepristone","status":"publish","type":"post","link":"https:\/\/buradabiliyorum.com\/en\/judge-suspends-fda-approval-of-mifepristone\/","title":{"rendered":"#Judge suspends FDA approval of mifepristone"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_85 counter-hierarchy ez-toc-counter ez-toc-custom ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a3e213a0f7f7\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #dd3333;color:#dd3333\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #dd3333;color:#dd3333\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a3e213a0f7f7\" checked aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/buradabiliyorum.com\/en\/judge-suspends-fda-approval-of-mifepristone\/#The_case_could_be_a_new_test_for_the_Supreme_Court\" >The case could be a new test for the Supreme Court<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/buradabiliyorum.com\/en\/judge-suspends-fda-approval-of-mifepristone\/#Reactions_to_Kacsmaryks_decision\" >Reactions to Kacsmaryk\u2019s decision<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/buradabiliyorum.com\/en\/judge-suspends-fda-approval-of-mifepristone\/#An_unprecedented_legal_challenge_to_the_FDAs_approval_process\" >An unprecedented legal challenge to the FDA&#8217;s approval process<\/a><\/li><\/ul><\/nav><\/div>\n<div>\n<p class=\"\">In an unprecedented move, U.S. District Judge Matthew Kacsmaryk on Friday suspended the Food and Drug Administration&#8217;s longtime <a href=\"https:\/\/buradabiliyorum.com\/en\/category\/download-scripts-themes-apps\/\" data-internallinksmanager029f6b8e52c=\"9\" title=\"Download Scripts &amp; Themes &amp; Apps\" target=\"_blank\" rel=\"noopener\">app<\/a>roval of key abortion pill mifepristone, though he gave the government a week to appeal his decision. If the ruling does eventually go into effect, it would curtail access to the standard regimen for medication abortion nationwide.<\/p>\n<p class=\"\">The FDA approved mifepristone more than 20 years ago to be used in combination with a second drug, misoprostol, to terminate pregnancies at up to 10 weeks. Over half of U.S. abortions are done by medication abortion, according to the Guttmacher Institute, a research group that supports abortion rights. <\/p>\n<p class=\"\">The pills have become increasingly significant in the fights over abortion access that have ensued since Roe v. Wade was overturned.<\/p>\n<p class=\"\">President Joe Biden on Friday said his administration would fight the ruling, and the Justice Department signaled it would appeal.<\/p>\n<p class=\"\">A coalition of anti-abortion groups, collectively called the Alliance for Hippocratic Medicine, sued in November challenging the process through which the FDA evaluated and approved mifepristone. They argue that the government did not adequately assess the drug\u2019s safety and should not have made it accessible via telehealth during the pandemic.\u00a0<\/p>\n<p class=\"\">The plaintiffs sought an injunction \u2014  which the judge granted, in part \u2014  to halt the use of mifepristone nationwide while the case plays out. <\/p>\n<p class=\"\">&#8220;The Court does not second-guess FDA\u2019s decision-making lightly,&#8221; Kacsmaryk wrote. &#8220;But here, FDA acquiesced on its legitimate safety concerns \u2014 in violation of its statutory duty \u2014 based on plainly unsound reasoning and studies that did not support its conclusions.&#8221;\u00a0<\/p>\n<p class=\"\">If the stay on the FDA&#8217;s mifepristone approval goes into effect, the drug would no longer be available anywhere in the U.S. That would leave a surgical procedure or off-label use of misoprostol on its own as the only options in states where abortion is legal.\u00a0\u00a0<\/p>\n<p class=\"\">Misoprostol, which is not affected by the injunction, is not FDA-approved to terminate pregnancies on its own \u2014\u00a0doctors would have to prescribe it off-label for that purpose. Some abortion providers said they intend to do that if access to mifepristone is cut off, even though the one-drug approach has been shown in <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/journals.lww.com\/greenjournal\/Abstract\/2019\/01000\/Efficacy_of_Misoprostol_Alone_for_First_Trimester.19.aspx\">clinical trials<\/a> to be somewhat less effective than the two-pill regimen.\u00a0<\/p>\n<p class=\"\">Biden said the Texas ruling poses a risk to abortion rights everywhere in the nation.<\/p>\n<p class=\"\">\u201cThis does not just affect women in Texas \u2014 if it stands, it would prevent women in every state from accessing the medication, regardless of whether abortion is legal in a state,\u201d Biden <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.whitehouse.gov\/briefing-room\/statements-releases\/2023\/04\/07\/statement-from-president-joe-biden-on-decision-in-alliance-for-hippocratic-medicine-v-fda\/\">said in a statement<\/a>. \u201cIt is the next big step toward the national ban on abortion that Republican elected officials have vowed to make law in America.\u201d<\/p>\n<p class=\"\">On Friday night, the Department of Justice filed a notice of appeal to the Fifth Circuit Court of Appeals, indicating that the government plans to appeal. Attorney <a href=\"https:\/\/buradabiliyorum.com\/en\/category\/general\/\" data-internallinksmanager029f6b8e52c=\"3\" title=\"General\" target=\"_blank\" rel=\"noopener\">General<\/a> Merrick Garland also said in a statement that the DOJ plans to appeal Kacsmaryk\u2019s decision.<\/p>\n<p class=\"\">\u201cToday\u2019s decision overturns the FDA\u2019s expert judgment, rendered over two decades ago, that mifepristone is safe and effective. The Department will continue to defend the FDA\u2019s decision,\u201d Garland said.<\/p>\n<p class=\"\">Defendant Danco Laboratories, which manufactures mifepristone, also filed a notice of appeal to the Fifth Circuit on Friday.<\/p>\n<h2 class=\"\"><span class=\"ez-toc-section\" id=\"The_case_could_be_a_new_test_for_the_Supreme_Court\"><\/span>The case could be a new test for the Supreme Court<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"\">The Supreme Court is likely to have the final word on whether the Texas ruling goes into effect.<\/p>\n<p class=\"\">Even if the Fifth Circuit Court in New Orleans does block Kacsmaryk\u2019s ruling, the challengers could ask the Supreme Court to overturn that decision.<\/p>\n<p class=\"\">So either way, the case is likely to test the Supreme Court\u2019s pronouncement last summer when it overturned Roe v. Wade on a 5-4 vote that it was leaving the issue of abortion to the states and other branches of government to decide as a policy question. <\/p>\n<section class=\"embed-widget embedWidget embed-widget--medium\"><\/section>\n<p class=\"\"> In his concurring opinion, Justice Brett Kavanaugh stressed that the ruling \u201cdoes not prevent the numerous states that readily allow abortion from continuing to allow abortion.\u201d <\/p>\n<p class=\"\">The votes of Kavanaugh and Chief Justice John Roberts, who voted against overturning Roe, could be pivotal.\u00a0<\/p>\n<h2 class=\"\"><span class=\"ez-toc-section\" id=\"Reactions_to_Kacsmaryks_decision\"><\/span>Reactions to Kacsmaryk\u2019s decision<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"\">Vice President Kamala Harris said on Friday that the Biden administration \u201cwill stand with the women of America.&#8221; <\/p>\n<p class=\"\">&#8220;Today\u2019s unprecedented decision threatens the rights of women nationwide to make decisions about their health care and the ability to access medication prescribed to them by their doctors,&#8221; she said in a statement. &#8220;Simply put: this decision undermines the FDA\u2019s ability to approve safe and effective medications \u2014 from chemotherapy drugs, to asthma medicine, to blood pressure pills, to insulin \u2014 based on <a href=\"https:\/\/buradabiliyorum.com\/en\/category\/sciencee\/\" data-internallinksmanager029f6b8e52c=\"5\" title=\"Science\" target=\"_blank\" rel=\"noopener\">science<\/a>, not politics. This decision threatens the rights of Americans across the country, who can look in their medicine cabinets and find medication prescribed by a doctor because the FDA engaged in a process to determine the efficacy and safety of that medication.&#8221;<\/p>\n<p class=\"\">Erik Baptist, senior counsel for the Alliance Defending Freedom, which represents the plaintiffs in the Texas case, said the FDA never had the authority to approve abortion pills. <\/p>\n<p class=\"\">\u201cThis is a significant victory for the doctors and medical associations we represent, and more importantly the health and safety of women and girls,\u201d he said.<\/p>\n<p class=\"\">However, Nancy Northup, president and CEO at the Center for Reproductive Rights, said in a statement that the decision &#8220;has no basis in law or fact.&#8221;<\/p>\n<p class=\"\">&#8220;This lawsuit was manufactured as part of an orchestrated campaign to deny all women in the U.S. access to abortion, even those living in states with strong abortion rights protections,&#8221; she said.<\/p>\n<h2 class=\"\"><span class=\"ez-toc-section\" id=\"An_unprecedented_legal_challenge_to_the_FDAs_approval_process\"><\/span>An unprecedented legal challenge to the FDA&#8217;s approval process<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"\">In the lawsuit, the Alliance for Hippocratic Medicine alleges that medication abortion has \u201cpotentially serious and life-threatening effects.\u201d However, studies suggest that when mifepristone and misoprostol are used together in consultation with doctors, the regimen successfully terminates pregnancies up to <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/26241252\/\">99.6% of the time<\/a> and has a <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/22898359\/\">0.4% risk of major complications<\/a>.<\/p>\n<p class=\"\">In court filings, the FDA said that it \u201cextensively reviewed the scientific evidence and determined that the benefits of mifepristone outweigh any risks\u201d and that the \u201cpublic interest would be dramatically harmed\u201d if the drug were removed from the market.\u00a0<\/p>\n<p class=\"\">It also called the lawsuit \u201cextraordinary and unprecedented.\u201d<\/p>\n<p class=\"\">There is little legal precedent for a court to overturn an FDA approval of a drug. <\/p>\n<p class=\"\">However, some abortion rights advocates expected this decision from Kacsmaryk, a Trump appointee who earlier in his career represented a Christian conservative legal group called First Liberty Institute. The group sued the federal government challenging the part of the Affordable Care Act that required employers to provide free insurance coverage for birth control.<\/p>\n<p class=\"\"><strong>Biden in his statement Friday said that \u201cthe Court in this case has substituted its judgment for FDA, the expert agency that approves drugs.\u201d<\/strong><\/p>\n<p class=\"\"><strong>\u201cIf this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks,\u201d Biden said.<\/strong><\/p>\n<p class=\"\">The legal fight over abortion pills going forward may be complicated by a second ruling that came minutes after the Texas decision. In a separate case, a federal judge in Washington state issued a preliminary injunction barring the FDA from &#8220;altering the status quo and rights as it relates to the availability of mifepristone.&#8221;<\/p>\n<p class=\"\">In that case, a coalition of Democratic attorneys general in February challenged the FDA\u2019s regulations on mifepristone and asked the court to remove \u201cunnecessary\u201d restrictions that could limit access to it. <\/p>\n<p class=\"endmark\">However, the ruling from the judge in Washington state applies only to the 18 states that sued.<\/p>\n<\/div>\n<blockquote><p><strong><span style=\"color: #ff6600;\">If you liked the article, do not forget to share it with your friends. Follow us on\u00a0<span style=\"color: #ff0000;\"><a style=\"color: #ff0000;\" href=\"https:\/\/news.google.com\/publications\/CAAqBwgKMLG0nwswvr63Aw\" target=\"_blank\" rel=\"nofollow noopener noreferrer\">Google News<\/a><\/span>\u00a0too, click on the star and choose us from your favorites.<\/span><\/strong><\/p><\/blockquote>\n<blockquote>\n<p style=\"text-align: center;\">For forums sites go to <span style=\"color: #ff9900;\"><a style=\"color: #ff9900;\" href=\"https:\/\/forum.buradabiliyorum.com\/\" target=\"_blank\" rel=\"noopener\">Forum.BuradaBiliyorum.Com<\/a><\/span><\/strong><\/p>\n<\/blockquote>\n<blockquote>\n<p style=\"text-align: center;\"><strong>If you want to read more <a href=\"https:\/\/buradabiliyorum.com\/en\/category\/news\/\" data-internallinksmanager029f6b8e52c=\"2\" title=\"News\" target=\"_blank\" rel=\"noopener\">News<\/a> articles, you can visit our <span style=\"color: #ff9900;\"><a style=\"color: #ff9900;\" href=\"https:\/\/en.buradabiliyorum.com\/news\/\" target=\"_blank\" rel=\"noopener\">News category.<\/a><\/span><\/strong><\/p>\n<\/blockquote>\n<p><span style=\"color: black;\"><a style=\"color: #ff9900;\" href=\"https:\/\/www.nbcnews.com\/news\/us-news\/abortion-pill-case-texas-judge-halts-access-mifepristone-rcna72117\" target=\"_blank\" rel=\"noopener\">Source<\/a><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In an unprecedented move, U.S. District Judge Matthew Kacsmaryk on Friday suspended the Food and Drug Administration&#8217;s longtime approval of key abortion pill mifepristone, though he gave the government a week to appeal his decision. If the ruling does eventually go into effect, it would curtail access to the standard regimen for medication abortion nationwide&#8230;.<\/p>\n","protected":false},"author":1,"featured_media":569310,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"fifu_image_url":"https:\/\/media-cldnry.s-nbcnews.com\/image\/upload\/t_nbcnews-fp-1200-630,f_auto,q_auto:best\/rockcms\/2022-06\/220628-abortion-pill-Mifepristone-mn-2225-54ab78.jpg","fifu_image_alt":"","footnotes":""},"categories":[70897],"tags":[],"class_list":["post-569309","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts\/569309","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/comments?post=569309"}],"version-history":[{"count":0,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts\/569309\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/media\/569310"}],"wp:attachment":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/media?parent=569309"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/categories?post=569309"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/tags?post=569309"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}