{"id":1912939,"date":"2023-04-11T06:57:06","date_gmt":"2023-04-11T10:57:06","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/everything-you-need-to-know-about-the-case-freezing-the-fdas-abortion-pill-approval\/"},"modified":"2023-04-11T06:58:13","modified_gmt":"2023-04-11T10:58:13","slug":"everything-you-need-to-know-about-the-case-freezing-the-fdas-abortion-pill-approval","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/everything-you-need-to-know-about-the-case-freezing-the-fdas-abortion-pill-approval\/","title":{"rendered":"Everything You Need To Know About The Case Freezing The FDA\u2019s Abortion Pill Approval"},"content":{"rendered":"<aside class=\"mashsb-container mashsb-main mashsb-stretched\"><div class=\"mashsb-box\"><div class=\"mashsb-count mash-medium\" style=\"&quot;\"><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%2Feverything-you-need-to-know-about-the-case-freezing-the-fdas-abortion-pill-approval%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=1912939&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--><div class=\"article-content\">\n<p>In a 67-page opinion in <em>Alliance for Hippocratic Medicine v. FDA, <\/em>a federal judge on Friday \u201cstayed\u201d the FDA\u2019s Sept. 28, 2000, approval of the abortion pill and the agency\u2019s follow-up decisions from 2016, 2019, and 2021. <\/p>\n<p>The detailed opinion by Judge Matthew Kacsmaryk, a Trump appointee, <a href=\"https:\/\/thefederalist.com\/2023\/04\/10\/judges-abortion-pill-opinion-tells-the-truth-about-unborn-humans-and-the-left-cant-stand-it\/\" target=\"_blank\" rel=\"noreferrer noopener\">addresses an array<\/a> of complex legal issues. Here\u2019s what you need to know to understand the litigation.<\/p>\n<div class=\"fdrlst__b89e9-paragraph-2-long d-flex justify-content-center\" style=\"margin-left: auto; margin-right: auto; text-align: center; \" id=\"fdrlst__b89e9-1257581972\">\n<div id=\"div-gpt-ad-1379703300879-0\" class=\"mb-30\"><\/div>\n<\/div>\n<div  class=\"fdrlst__b89e9-f8fb395146923598eb13b84cff3f3c38 fdrlst__b89e9-paragraph-2\" id=\"fdrlst__b89e9-f8fb395146923598eb13b84cff3f3c38\"><\/div>\n<h2 class=\"wp-block-heading\">Facts First<\/h2>\n<p>In 1996, the Population Council filed an application with the FDA seeking approval of the abortion pill, which is really two pills: mifepristone, also known as RU-486, and misoprostol. Mifepristone blocks the production of progesterone causing the death of the unborn human, who is nurtured by progesterone in utero. Misoprostol then induces \u201ccramping and contractions to expel the unborn human from the mother\u2019s womb.\u201d<\/p>\n<p>The FDA told the Population Council in February of 2000 that it did not believe the evidence submitted adequately demonstrated that the drug, if distributed as proposed, was safe and effective for use. Accordingly, the FDA concluded, the \u201crestrictions on distribution will need to be amended.\u201d Yet a few months later, the FDA approved the abortion drug under its Subpart H \u201caccelerated approval\u201d process.\u00a0<\/p>\n<p>The FDA\u2019s approval was for use of the drug up to seven-weeks gestation and required three in-person office visits, first to administer mifepristone, second to administer misoprostol, and third to assess any complications and ensure the abortion had been complete. Additionally, prescribers were required to be properly trained and to report any adverse events.\u00a0<\/p>\n<p>In 2002, the plaintiffs filed a \u201ccitizen petition\u201d with the FDA, objecting to the agency\u2019s approval of the abortion drug. It was not until nearly 14 years later, however, on March 29, 2016, that the FDA rejected the plaintiffs\u2019 2002 petition. The same day the FDA rejected the petition challenging the initial approval of the abortion drug, the FDA removed several of the restrictions on its distribution.\u00a0<\/p>\n<div  class=\"fdrlst__b89e9-ee0cbdda5b8c22f0474d2fb806251e27 fdrlst__b89e9-paragraph-6\" id=\"fdrlst__b89e9-ee0cbdda5b8c22f0474d2fb806251e27\"><\/div>\n<p>Specifically, in 2016, the FDA increased the maximum gestational age from seven weeks to 10 weeks. The FDA also reduced the number of office visits from three to one, allowed non-doctors to prescribe and administer the drug, changed the dosage, and eliminated the requirement that adverse events be reported, unless they proved fatal.<\/p>\n<p>Plaintiffs filed a second citizen petition with the FDA in 2019, challenging the FDA\u2019s 2016 removal of the various safety restrictions. On Dec. 16, 2021, the FDA denied the 2019 petition. In the interim, in 2019, the FDA approved the distribution of a generic version of the abortion pill. On April 12, 2021, the FDA announced it would allow mifepristone to be dispensed through the mail, ostensibly due to Covid, but the FDA has since made mail distribution a permanent option.\u00a0<\/p>\n<p>In November of 2022, the plaintiffs, who consist of doctors and national medical associations that provide health care for pregnant and post-abortive women and girls, sued the FDA, challenging the initial 2000 approval of the abortion drug, the removal of the safety precautions in 2016, the approval of the generic chemical-abortion drugs in 2019, and the 2021 decision to permit the distribution of the drug via the mail. Soon after, the plaintiffs filed a motion for a preliminary injunction, seeking a court order directing the defendants to withdraw or suspend the various FDA decisions.<\/p>\n<h2 class=\"wp-block-heading\">Do the Plaintiffs Have Standing?<\/h2>\n<p>Before addressing the merits of the case, the court analyzed the initial question of \u201cstanding,\u201d or whether the plaintiffs have the right to sue. To have standing, plaintiffs must generally show they suffered a concrete injury, caused by the defendant, that can be \u201credressed\u201d by the court.\u00a0<\/p>\n<div  class=\"fdrlst__b89e9-6d0fe50c2c2b945741b9ead0a7af2809 fdrlst__b89e9-paragraph-10\" id=\"fdrlst__b89e9-6d0fe50c2c2b945741b9ead0a7af2809\"><\/div>\n<p>The court held the plaintiffs had standing to sue as an association whose members had standing. Those members, who are doctors, have standing, the court held, because they alleged that the approval of the dangerous abortion drugs injures them by overwhelming the medical system and placing \u201cenormous pressure and stress\u201d on the doctors during emergencies and complications.\u00a0<\/p>\n<p>Friday\u2019s opinion further concluded the medical association members had standing to challenge the FDA\u2019s decision on behalf of their patients. Here, the court noted the Supreme Court has allowed abortion doctors to represent the interests of women seeking abortions, notwithstanding the conflict of interest between the two \u2014 with the abortionists often seeking to scrap laws designed to protect their patients. In this case, the court reasoned, the doctors\u2019 relationship with patients is at least as close, if not closer, further justifying standing.<\/p>\n<p>A third basis for standing exists, the court added, based on the harm to the association itself because the FDA\u2019s approval of the abortion drug forces the plaintiffs to redirect their resources from other activities to educate the public on the dangers of the abortion pill.\u00a0<\/p>\n<h2 class=\"wp-block-heading\">Did the Plaintiffs Wait Too Long to Sue?<\/h2>\n<p>A second preliminary question the court addressed concerns the timeliness of the lawsuit. The FDA argued the plaintiffs\u2019 challenge to the 2000 approval of the abortion pill was time-barred because it had rejected the citizen petition in 2016 and the statute of limitations is six years. The court rejected that argument, holding that by undertaking a full review of the safety provisions in 2019, the FDA had restarted the limitation period.\u00a0<\/p>\n<p>Alternatively, the court concluded the plaintiffs\u2019 challenge to the 2000 approval is not time-barred based on the principle of equitable tolling. \u201cIt took FDA 13 years, 7 months, and 9 days to respond to the 2002 Petition,\u201d the court stressed. Then in responding, the FDA \u201cmoved the goalposts by substantially changing the regulatory scheme on the same day it issued its Response.\u201d <\/p>\n<p>Another delay soon followed, with the FDA taking almost three years to respond to the 2019 petition. \u201cThus, in the 20 years between the 2002 Petition and the filing of this suit, Plaintiffs were waiting on FDA for over 16 of those years,\u201d the court noted, saying fairness favored the plaintiffs under these circumstances.<\/p>\n<h2 class=\"wp-block-heading\">Must the Plaintiffs Wait Years More Before Suing?<\/h2>\n<p>The Biden administration presented one more preliminary challenge to the lawsuit, arguing the plaintiffs could not challenge the FDA\u2019s 2019 approval of a generic version of the abortion drug or the FDA\u2019s 2021 decision to allow the distribution of the drugs via the mail because they did not \u201cexhaust\u201d their administrative remedies, meaning they did not present these complaints to the FDA first.<\/p>\n<p>The court rejected this argument as well, finding exhaustion was not required for a variety of reasons \u2014 explained in detail in the opinion \u2014 including that seeking review by the FDA would be \u201cfutile.\u201d <\/p>\n<p>\u201cAny attempt by Plaintiffs to challenge Defendants\u2019 actions would likely be futile,\u201d the court reasoned, because \u201ceven if Plaintiffs did not endure sixteen years of delay, dawdle, and dithering, their efforts would surely \u2018be futile because the administrative agency will clearly reject the claim.\u2019\u201d Here, the court pointed to President Biden\u2019s emphasis post-<em>Dobbs <\/em>on \u201cthe need to protect access to mifepristone.\u201d\u00a0<\/p>\n<h2 class=\"wp-block-heading\">Next, the Merits<\/h2>\n<p>Of the legal challenges, the narrowest one concerns the FDA\u2019s decision to allow the distribution of the abortion pill via the mail. Kacsmaryk held that that decision violates the 1873 Comstock Act, which makes it illegal to send by mail: \u201c[e]very article or thing designed, adapted, or intended for producing abortion,\u201d and \u201c[e]very article, instrument, substance, drug, medicine, or thing which is advertised or described in a manner calculated to lead another to use or apply it for producing abortion.\u201d<\/p>\n<p>Notwithstanding this plain language, the Biden administration argued the Comstock Act only prohibits the mailing of abortion drugs if the sender intends them to be used \u201cunlawfully.\u201d But that is not what the Comstock Act says, and Kacsmaryk held that when the language of a statute is clear, the court must enforce it as written.<\/p>\n<h2 class=\"wp-block-heading\">Could FDA Approve the Drugs under Subpart H?<\/h2>\n<p>As noted above, the FDA approved the abortion pill in 2000 under the auspices of its Subpart H, titled, \u201cAccelerated Approval of New Drugs for Serious or Life-Threatening Illnesses.\u201d Approval under Subpart H requires drugs to satisfy two requirements. First, drug studies must establish its \u201csafety and effectiveness in treating serious or life-threatening illnesses.\u201d Second, the drug must \u201cprovide [a] meaningful therapeutic benefit to patients over existing treatments.\u201d\u00a0<\/p>\n<p>The court held the FDA\u2019s approval of the abortion pill in 2000 violated Subpart H first because it did not \u201ctreat\u201d a \u201cserious or life-threatening illness,\u201d and second because it did not provide a therapeutic benefit\u201d over surgical abortions. In reaching these conclusions, the court stressed that pregnancy is not a sickness, much less a \u201clife-threatening\u201d one, and that the FDA lacked any evidence showing the abortion pill provided a benefit over surgical abortion.<\/p>\n<h2 class=\"wp-block-heading\">Did FDA Act Arbitrarily and Capriciously?<\/h2>\n<p>The final question before the court concerned the legality of the FDA\u2019s approval of the abortion pill and its generic offspring. By statute, the FDA must deny approval of a new drug application if the agency has insufficient information to determine if the drug is safe for use as intended.\u00a0<\/p>\n<p>In seeking approval of the abortion pill, the applicant, the Population Council, relied on U.S. trials that required: <\/p>\n<blockquote class=\"wp-block-quote\">\n<p>(1) each woman receive an ultrasound to confirm gestational age and exclude an ectopic pregnancy; (2) physicians have experience in performing surgical abortions and admitting privileges at medical facilities that provide emergency care; (3) all patients be within one hour of emergency facilities or the facilities of the principal investigator; and (4) women be monitored for four hours to check for adverse events after taking misoprostol.<\/p>\n<\/blockquote>\n<p>Yet the original 2000 approval and then the later modifications lacked these basic safety precautions. These omissions, the court stressed, and especially the FDA\u2019s failure to require an ultrasound to identify ectopic pregnancies, increased the danger of the abortion pill. The court also noted the FDA \u201centirely failed to consider an important aspect of the problem\u201d by omitting any evaluation of the psychological or long-term medical consequences of the drug.\u00a0<\/p>\n<p>What the court found most significant, however, was the FDA\u2019s initial conclusion that it lacked adequate information \u201cto demonstrate that the drug, when marketed in accordance with the terms of distribution proposed, is safe and effective for use as recommended.\u201d Notwithstanding that finding, the FDA, after political pressure, altered course and approved the abortion pill.\u00a0<\/p>\n<p>The court concluded that, under these circumstances, the FDA had acted arbitrarily and capriciously by acquiescing \u201con its legitimate safety concerns \u2014 in violation of its statutory duty.\u201d And because the generic approval relied on the flawed 2000 approval, that decision likewise was arbitrary and capricious, the court held.<\/p>\n<p>The FDA has already filed a notice of appeal to the Fifth Circuit Court of Appeals. On appeal, the Biden administration will reassert these various arguments. Whether the Fifth Circuit will agree with the FDA remains to be seen. But Kacsmaryk\u2019s thorough analysis of the record will make it difficult for the appellate court to hide behind the FDA\u2019s discretion because his opinion exposes the lack of scientific support for the FDA\u2019s approval of the abortion pill.\u00a0<\/p>\n<p>Time will tell, though \u2014 and maybe, too, the Supreme Court.<\/p>\n<div  class=\"fdrlst__b89e9-c79e090bb6ad1bb35bad556565f6d740 fdrlst__b89e9-after-post-content\" id=\"fdrlst__b89e9-c79e090bb6ad1bb35bad556565f6d740\"><\/div>\n<hr class=\"wp-block-separator\">\n<div class=\"article-author-description fst-italic\">   Margot Cleveland is The Federalist&#8217;s senior legal correspondent. She is also a contributor to National Review Online, the Washington Examiner, Aleteia, and Townhall.com, and has been published in the Wall Street Journal and USA Today.     Cleveland is a lawyer and a graduate of the Notre Dame Law School, where she earned the Hoynes Prize\u2014the law school\u2019s highest honor. She later served for nearly 25 years as a permanent law clerk for a federal appellate judge on the Seventh Circuit Court of Appeals. Cleveland is a former full-time university faculty member and now teaches as an adjunct from time to time.     As a stay-at-home homeschooling mom of a young son with cystic fibrosis, Cleveland frequently writes on cultural issues related to parenting and special-needs children. Cleveland is on Twitter at @ProfMJCleveland. The views expressed here are those of Cleveland in her private capacity.<\/div>\n<div class=\"article-tags bdr-top-black mt-30 mt-sm-60 pt-15 pt-md-45\">\n<ul class=\"list-unstyled d-flex flex-wrap align-items-center mb-0 mx-n10 p-0\">\n<li class=\"mt-10 mx-10\"><a href=\"https:\/\/thefederalist.com\/tag\/abortion\/\" class=\"btn btn-black btn-small\">Abortion<\/a><\/li>\n<li class=\"mt-10 mx-10\"><a href=\"https:\/\/thefederalist.com\/tag\/abortion-pill\/\" class=\"btn btn-black btn-small\">abortion pill<\/a><\/li>\n<li class=\"mt-10 mx-10\"><a href=\"https:\/\/thefederalist.com\/tag\/biden-administration\/\" class=\"btn btn-black btn-small\">Biden administration<\/a><\/li>\n<li class=\"mt-10 mx-10\"><a href=\"https:\/\/thefederalist.com\/tag\/chemical-abortion\/\" class=\"btn btn-black btn-small\">chemical abortion<\/a><\/li>\n<li class=\"mt-10 mx-10\"><a href=\"https:\/\/thefederalist.com\/tag\/drugs\/\" class=\"btn btn-black btn-small\">drugs<\/a><\/li>\n<li class=\"mt-10 mx-10\"><a href=\"https:\/\/thefederalist.com\/tag\/ectopic-pregnancy\/\" class=\"btn btn-black btn-small\">ectopic pregnancy<\/a><\/li>\n<li class=\"mt-10 mx-10\"><a href=\"https:\/\/thefederalist.com\/tag\/fda\/\" class=\"btn btn-black btn-small\">FDA<\/a><\/li>\n<li class=\"mt-10 mx-10\"><a href=\"https:\/\/thefederalist.com\/tag\/food-and-drug-administration\/\" class=\"btn btn-black btn-small\">Food and Drug Administration<\/a><\/li>\n<li class=\"mt-10 mx-10\"><a href=\"https:\/\/thefederalist.com\/tag\/health-care-2\/\" class=\"btn btn-black btn-small\">health care<\/a><\/li>\n<li class=\"mt-10 mx-10\"><a href=\"https:\/\/thefederalist.com\/tag\/mifepristone\/\" class=\"btn btn-black btn-small\">mifepristone<\/a><\/li>\n<li class=\"mt-10 mx-10\"><a href=\"https:\/\/thefederalist.com\/tag\/misoprostol\/\" class=\"btn btn-black btn-small\">misoprostol<\/a><\/li>\n<li class=\"mt-10 mx-10\"><a href=\"https:\/\/thefederalist.com\/tag\/roe-v-wade\/\" class=\"btn btn-black btn-small\">Roe v. Wade<\/a><\/li>\n<li class=\"mt-10 mx-10\"><a href=\"https:\/\/thefederalist.com\/tag\/surgical-abortion\/\" class=\"btn btn-black btn-small\">surgical abortion<\/a><\/li>\n<\/ul><\/div>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>In a 67-page opinion in Alliance for Hippocratic Medicine v. FDA, a federal judge on Friday \u201cstayed\u201d the FDA\u2019s Sept. 28, 2000, approval of the abortion pill and the agency\u2019s follow-up decisions from 2016, 2019, and 2021. The detailed opinion by Judge Matthew Kacsmaryk, a Trump appointee, addresses an array of complex legal issues. Here\u2019s<\/p>\n","protected":false},"author":499,"featured_media":1912940,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","fifu_image_alt":"","footnotes":""},"categories":[546],"tags":[4310,4886,16415,11831,15128],"class_list":["post-1912939","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-the-federalist","tag-abortion","tag-approval","tag-fdas","tag-freezing","tag-pill"],"fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","_links":{"self":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1912939","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\/499"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=1912939"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1912939\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/1912940"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=1912939"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=1912939"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=1912939"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}