{"id":308986,"date":"2024-03-21T16:34:26","date_gmt":"2024-03-21T21:34:26","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=308986"},"modified":"2024-03-24T22:45:42","modified_gmt":"2024-03-25T03:45:42","slug":"separating-fact-fiction-supreme-court-abortion-pill","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/separating-fact-fiction-supreme-court-abortion-pill\/","title":{"rendered":"Separating fact from fiction in the Supreme Court&#8217;s upcoming abortion pill case"},"content":{"rendered":"<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div><p>An abortion pill lawsuit set to be heard before the United States Supreme Court on March 26, 2024, <em><strong>will not<\/strong><\/em> result in the removal of the drug from the market, as some have suggested. Here&#8217;s what you need to know&#8230;<\/p>\n<h3><strong>FACT: Abortion drugs have been available since <a href=\"https:\/\/archive.liveaction.org\/news\/abortion-pill-21-years-secrecy-death\/\" target=\"_blank\" rel=\"noopener\">approval<\/a> in 2000 and will continue to be available after the case is heard<\/strong><\/h3>\n<p>The case, <em>Alliance for Hippocratic Medicine (AHM) v. Food and Drug Administration (FDA), <\/em>challenges the FDA&#8217;s more recent expansion of the drug mifepristone (Mifeprex). AHM Plaintiffs are represented by Alliance Defending Freedom (ADF).<\/p>\n<p>The FDA&#8217;s more <em>recent<\/em> expansions of the drug occurred when the FDA moved away from the required in-person visits to obtain the pills (where medical professionals would likely provide more comprehensive medical assessments or examinations prior to prescribing the pills), to approving the dispensing of abortion drugs virtually, by mail, or at the pharmacy counter \u2014 where little to no time would be spent evaluating the client.<\/p>\n<p>In AHM&#8217;s abortion pill lawsuit, \u201cThe Court is reviewing the FDA\u2019s recklessness in removing nearly all its original safety standards for the use of abortion drugs to the detriment of women\u2019s health and safety. Regardless of the outcome, abortion drugs will remain available in the United States. We are simply asking the Court to reinstate the original standards that were in effect for over 15 years,\u201d Alliance Defending Freedom Senior Counsel Erik Baptist told Live Action News.<\/p>\n<div class=\"video-container\">\n<blockquote class=\"twitter-tweet\" data-width=\"550\" data-dnt=\"true\">\n<p lang=\"en\" dir=\"ltr\">The abortion industry wants you to believe certain narratives about our upcoming Supreme Court case against the FDA.<\/p>\n<p>It&#39;s time to separate myth from fact. Let&#39;s dive in \ud83e\uddf5<\/p>\n<p>&mdash; Alliance Defending Freedom (@ADFLegal) <a href=\"https:\/\/twitter.com\/ADFLegal\/status\/1770483676045803837?ref_src=twsrc%5Etfw\">March 20, 2024<\/a><\/p><\/blockquote>\n<p><script async src=\"https:\/\/platform.twitter.com\/widgets.js\" charset=\"utf-8\"><\/script><\/div>\n<p><strong>Lawsuit Background<\/strong><\/p>\n<p>The <a href=\"https:\/\/archive.liveaction.org\/news\/plaintiffs-supreme-court-abortion-pill-fda-jeopardizing\/\" target=\"_blank\" rel=\"noopener\">lawsuit<\/a>, <em>Alliance for Hippocratic Medicine (AHM) v. Food and Drug Administration (FDA), <\/em>was <a href=\"https:\/\/lozierinstitute.org\/what-is-the-truth-about-the-alliance-for-hippocratic-medicine-v-u-s-food-and-drug-administration-lawsuit\/\" target=\"_blank\" rel=\"noopener\">initiated<\/a> in November of 2022 by a group of medical doctors and organizations who claimed the 2000 approval of the drug was illegal and the expanded use of the abortion pill was <a href=\"https:\/\/archive.liveaction.org\/news\/doctors-alarm-abortion-pill-complications\/\" target=\"_blank\" rel=\"noopener\">unsafe<\/a>.\u00a0 The doctors\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/doctors-fda-abortion-pill-decades-medical-negligence\/\" target=\"_blank\" rel=\"noopener\">testified<\/a>\u00a0to treating women with severe complications \u2014 \u201cmany who presented to the emergency room.\u201d<\/p>\n<p>On April 7, 2023, U.S. District Court Judge Matthew J. Kacsmaryk\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/district-court-judge-revoke-fda-abortion-pill\/\" target=\"_blank\" rel=\"noopener\">ruled<\/a> in favor of the plaintiffs to immediately suspend the 2000 approval and subsequent FDA changes to the abortion pill. But the case was appealed to the U.S. Court of Appeals for the Fifth Circuit, which issued a partial stay.<\/p>\n<p>In May of 2023, AHM\u2019s abortion pill lawsuit <a href=\"https:\/\/archive.liveaction.org\/news\/judges-abortion-pill-approval-pregnancy-illness\/\" target=\"_blank\" rel=\"noopener\">went back<\/a> to be heard again by the Fifth Circuit where a <a href=\"https:\/\/www.ca5.uscourts.gov\/opinions\/pub\/23\/23-10362-CV1.pdf\">62-page decision<\/a>\u00a0issued August 16, 2023, by the Appeals Court\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/court-fda-abortion-pill-safety-supreme\/\" target=\"_blank\" rel=\"noopener\">ruled<\/a>\u00a0to allow mifepristone to remain \u201cavailable to the public under the conditions for use that\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/fda-abortion-pill-timeline-events\/\" target=\"_blank\" rel=\"noopener\">existed<\/a>\u201d\u00a0<em>prior to 2016<\/em>. That decision would therefore remove mail-order and <a href=\"https:\/\/archive.liveaction.org\/news\/fda-retail-pharmacies-abortion-pills-prescription\/\" target=\"_blank\" rel=\"noopener\">pharmacy dispensing<\/a> of the drug while leaving in place the FDA\u2019s 2000 approval as well as its 2019 approval of the generic version (GenBioPro).<\/p>\n<p>The pill has remained available under an <a class=\"c-link\" href=\"https:\/\/www.bloomberg.com\/news\/articles\/2023-04-21\/us-supreme-court-puts-abortion-pill-restrictions-on-hold\" target=\"_blank\" rel=\"noopener noreferrer\" data-stringify-link=\"https:\/\/www.bloomberg.com\/news\/articles\/2023-04-21\/us-supreme-court-puts-abortion-pill-restrictions-on-hold\" data-sk=\"tooltip_parent\">April order<\/a> from the U.S. Supreme Court and will stay in effect until the high court hears the case later this month.<\/p>\n<h3><strong>FACT: The FDA Removed Essential Safeguards for the Abortion Pill<\/strong><\/h3>\n<p>AHM&#8217;s <a href=\"https:\/\/adfmedialegalfiles.blob.core.windows.net\/files\/AHM-OpeningBrief.pdf\" target=\"_blank\" rel=\"noopener\">brief<\/a>\u00a0claimed that the \u201cFDA\u2019s removal of safeguards for abortion drugs was arbitrary, capricious, an abuse of discretion, and otherwise unlawful.\u201d<\/p>\n<p>Alliance Defending Freedom, which is representing AHM, claimed that its clients are &#8220;on the front lines witnessing the harms the FDA has caused&#8221; by caring for women and girls &#8220;facing severe health complications because of the FDA\u2019s illegal actions.&#8221;<\/p>\n<p>According to ADF, the FDA&#8217;s <a href=\"https:\/\/archive.liveaction.org\/news\/abortion-pill-dangerous-safety-requirement\/\" target=\"_blank\" rel=\"noopener\">2000 approval<\/a> identified as essential that:<\/p>\n<ul>\n<li>Women must be seven weeks pregnant or less to take the drugs;<\/li>\n<li>Women must have at least three in-person doctor visits to prevent severe and even life-threatening complications;<\/li>\n<li>A doctor must prescribe the drugs; and<\/li>\n<li>A doctor must report all complications women suffer from the drugs.<\/li>\n<\/ul>\n<p>AHM&#8217;s abortion pill lawsuit is asking the Supreme Court to reinstate &#8220;essential safeguards&#8221; put in place on the abortion pill in a safety system called REMS by the FDA prior to <a href=\"https:\/\/archive.liveaction.org\/news\/fda-abortion-pill-timeline-events\/\" target=\"_blank\" rel=\"noopener\">2016<\/a>, when the FDA chose to \u201celiminate the requirement that prescribers report all serious adverse events,\u201d AHM claimed in its brief.<\/p>\n<p style=\"text-align: center;\"><iframe loading=\"lazy\" title=\"YouTube video player\" src=\"https:\/\/www.youtube.com\/embed\/gnEHZiud8dg?si=ntJJwjBPBeW_xht4\" width=\"640\" height=\"355\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><span data-mce-type=\"bookmark\" style=\"display: inline-block; width: 0px; overflow: hidden; line-height: 0;\" class=\"mce_SELRES_start\">\ufeff<\/span><\/iframe><\/p>\n<p>AHM added that \u201cfor 2016, FDA failed to consider a major aspect of the problem: \u2018the cumulative effect\u2019 of the interrelated changes.\u201d The FDA\u2019s changes, according to AHM, \u201cincreased the risk that more women taking abortion drugs will need emergency care\u201d in three ways:<\/p>\n<ul>\n<li>The FDA \u201cincreased the gestational-age limit from seven to ten weeks\u201d where the \u201c\u2018failure rate\u2019 climbs from roughly 2 to 7 percent, as confirmed by FDA\u2019s label.\u201d<\/li>\n<li>The \u201cFDA\u2019s removal of the Day 14 in-person follow-up visit\u201d will \u201cnaturally result[] in more women report[ing] to the emergency room.\u2019\u201d<\/li>\n<li>The FDA\u2019s decision to end the \u201crequirement that licensed doctors prescribe and provide ongoing care to women using abortion drug\u201d results \u2014 as the FDA concedes \u2014\u00a0in \u201cOB\/GYNs, OB\/GYN hospitalists, and emergency room doctors like Respondents \u2018who must manage the aftermath.\u2019\u201d<\/li>\n<\/ul>\n<p>ADF emphasized that it is the FDA\u2019s job to keep people safe, but claimed that the FDA abandoned that responsibility when it recklessly removed its own safety standards for abortion drugs.<\/p>\n<p>&#8220;After requiring critical safety standards for 16 years, the FDA removed them without sufficiently evaluating the impact on women\u2019s health. That failure violated the agency\u2019s duty to women and girls,&#8221; the organization claimed.<\/p>\n<h3><strong>FACT: Abortion Drug Label Suggests Potential Risks\u00a0<\/strong><\/h3>\n<p><a href=\"https:\/\/archive.liveaction.org\/news\/plaintiffs-supreme-court-abortion-pill-fda-jeopardizing\/\" target=\"_blank\" rel=\"noopener\">AHM<\/a>\u00a0has\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/emergency-room-visits-abortion-pill-tens-thouands\/\" target=\"_blank\" rel=\"noopener\">claimed<\/a>\u00a0in its\u00a0<a href=\"https:\/\/adfmedialegalfiles.blob.core.windows.net\/files\/AHM-OpeningBrief.pdf\" target=\"_blank\" rel=\"noopener\">brief<\/a>\u00a0that abortion pill-related emergency room visits are estimated to be in the tens of thousands, based on published percentages for ER visits on the drug\u2019s\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/020687Orig1s026lbl.pdf\" target=\"_blank\" rel=\"noopener\">2023 label<\/a>\u00a0which state that \u201c2.9 to 4.6 percent of women who take abortion drugs end up in the emergency room.\u201d<\/p>\n<p>This, AHM claimed, suggests \u201croughly one in 25 women who take mifepristone will end up in the emergency room.\u201d<\/p>\n<div class=\"video-container\">\n<blockquote class=\"twitter-tweet\" data-width=\"550\" data-dnt=\"true\">\n<p lang=\"en\" dir=\"ltr\">MYTH 2: \u201cThis case could take abortion drugs off the market.\u201d<\/p>\n<p>TRUTH: SCOTUS is not considering the drug\u2019s approval, which means it won\u2019t be taken off the market. We\u2019re asking for the restoration of basic safety standards the FDA illegally removed, like in-person doctor visits.<\/p>\n<p>&mdash; Alliance Defending Freedom (@ADFLegal) <a href=\"https:\/\/twitter.com\/ADFLegal\/status\/1770483678717632938?ref_src=twsrc%5Etfw\">March 20, 2024<\/a><\/p><\/blockquote>\n<p><script async src=\"https:\/\/platform.twitter.com\/widgets.js\" charset=\"utf-8\"><\/script><\/div>\n<p>In <a href=\"https:\/\/archive.liveaction.org\/news\/emergency-room-visits-abortion-pill-tens-thouands\/\" target=\"_blank\" rel=\"noopener\">addition<\/a>, AHM claimed that the FDA\u2019s\u00a0<a href=\"https:\/\/www.earlyoptionpill.com\/wp-content\/uploads\/2023\/03\/DANCO_MedGuide_ENG_Web.pdf\" target=\"_blank\" rel=\"noopener\">medication guide<\/a>\u00a0acknowledges that as many as seven percent (7%) of women will need surgery after taking mifepristone \u2018to stop bleeding\u2019 or to complete the abortion.<\/p>\n<div id=\"attachment_307576\" style=\"width: 859px\" class=\"wp-caption aligncenter\"><img aria-describedby=\"caption-attachment-307576\" decoding=\"async\" loading=\"lazy\" class=\"wp-image-307576\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2024\/02\/Mifepristone-Jan-2023-label-shows-percentage-of-women-taking-abortion-pill-visit-ER.jpg\" alt=\"Mifepristone Jan 2023 label shows percentage of women taking abortion pill visit Emergency room (ER)\" width=\"849\" height=\"1031\" aria-describedby=\"caption-attachment-307576\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2024\/02\/Mifepristone-Jan-2023-label-shows-percentage-of-women-taking-abortion-pill-visit-ER.jpg 959w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2024\/02\/Mifepristone-Jan-2023-label-shows-percentage-of-women-taking-abortion-pill-visit-ER-247x300.jpg 247w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2024\/02\/Mifepristone-Jan-2023-label-shows-percentage-of-women-taking-abortion-pill-visit-ER-576x700.jpg 576w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2024\/02\/Mifepristone-Jan-2023-label-shows-percentage-of-women-taking-abortion-pill-visit-ER-768x933.jpg 768w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2024\/02\/Mifepristone-Jan-2023-label-shows-percentage-of-women-taking-abortion-pill-visit-ER-500x607.jpg 500w\" sizes=\"(max-width: 849px) 100vw, 849px\" \/><p id=\"caption-attachment-307576\" class=\"wp-caption-text\">Mifepristone Jan 2023 label shows percentage of women taking abortion pill visit ER<\/p><\/div>\n<p>\u201cFDA\u2019s current label for mifepristone continues to require a Black Box warning because the drug can cause \u2018[s]erious and sometimes fatal infections and bleeding\u2019\u2026 It also directs women to emergency rooms if one of many adverse complications arise,\u201d AHM wrote in the brief.<\/p>\n<div id=\"attachment_307635\" style=\"width: 883px\" class=\"wp-caption aligncenter\"><img aria-describedby=\"caption-attachment-307635\" decoding=\"async\" loading=\"lazy\" class=\"wp-image-307635\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2024\/02\/Abortion-pill-Black-Box-warning-and-medication-guide-suggests-sending-women-to-ER.jpg\" alt=\"Abortion pill Black Box warning and medication guide suggests sending women to ER\" width=\"873\" height=\"783\" aria-describedby=\"caption-attachment-307635\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2024\/02\/Abortion-pill-Black-Box-warning-and-medication-guide-suggests-sending-women-to-ER.jpg 1383w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2024\/02\/Abortion-pill-Black-Box-warning-and-medication-guide-suggests-sending-women-to-ER-300x269.jpg 300w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2024\/02\/Abortion-pill-Black-Box-warning-and-medication-guide-suggests-sending-women-to-ER-700x628.jpg 700w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2024\/02\/Abortion-pill-Black-Box-warning-and-medication-guide-suggests-sending-women-to-ER-768x689.jpg 768w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2024\/02\/Abortion-pill-Black-Box-warning-and-medication-guide-suggests-sending-women-to-ER-500x449.jpg 500w\" sizes=\"(max-width: 873px) 100vw, 873px\" \/><p id=\"caption-attachment-307635\" class=\"wp-caption-text\">Abortion pill Black Box warning and medication guide suggests sending women to ER<\/p><\/div>\n<h3><strong>FACT: Abortion Pill Documents Suggest Tens of Thousands Could Seek Emergency Care<\/strong><\/h3>\n<p><a href=\"https:\/\/archive.liveaction.org\/news\/abortions-skyrocketing-63-by-abortion-pill\/\" target=\"_blank\" rel=\"noopener\">Data for 2023<\/a> indicates that abortion pill use <em>increased<\/em>\u00a0nearly 31% (30.57%) from the 492,210 reported abortion in\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/500k-preborn-human-abortion-pill-2020\/\" target=\"_blank\" rel=\"noopener\">2020<\/a>\u00a0(53% of all abortions) to <em><strong>642,700 abortion pills recorded by\u00a0<a href=\"https:\/\/www.guttmacher.org\/monthly-abortion-provision-study\" target=\"_blank\" rel=\"noopener\">2023<\/a>\u00a0(63% of all abortions).<\/strong><\/em><\/p>\n<ul>\n<li>Estimating ER visits from the newly published abortion pill data for 2023 reveals that out of the 642,700 abortion pills recorded by Guttmacher, <strong><em>between 19,000 (18,638) and 30,000 (29,564) women who took abortion drugs may have potentially ended up in the emergency room in 2023.<\/em><\/strong><\/li>\n<li>In addition, using the 2-7% figure off the medication guide, we estimate that <em><strong>between 13,000 and 45,000 women who took the abortion pill in 2023 potentially required \u201ca surgical procedure because the pregnancy did not completely pass from the uterus or to stop bleeding.\u201d<\/strong><\/em><\/li>\n<\/ul>\n<p>These percentages, backed up by <a href=\"https:\/\/archive.liveaction.org\/news\/emergency-room-visits-abortion-pill-tens-thouands\/\" target=\"_blank\" rel=\"noopener\">other studies,<\/a> are not small numbers, which is why AHM is asking that SCOTUS turn back the safety requirements to pre-2016. By doing so, women may have more thorough care in clinic than they are likely receiving now. Today, abortion insiders have even <a href=\"https:\/\/archive.liveaction.org\/news\/bad-actors-conceal-abortion-pill-complications\/\" target=\"_blank\" rel=\"noopener\">suggested<\/a>\u00a0that women should lie and claim to be miscarrying naturally when they present to the emergency room with abortion pill complications. This dampens any chance that accurate numbers on abortion pill complications or deaths will be reported as such to authorities.<\/p>\n<p>&#8220;SCOTUS is not considering the drug\u2019s approval, which means it won\u2019t be taken off the market. We\u2019re asking for the restoration of basic safety standards the FDA illegally removed, like in-person doctor visits,&#8221; ADF <a href=\"https:\/\/twitter.com\/ADFLegal\/status\/1770483678717632938\" target=\"_blank\" rel=\"noopener\">wrote<\/a> recently on X, <a href=\"https:\/\/twitter.com\/ADFLegal\/status\/1770483681607475509\">adding<\/a>, &#8220;EVERYONE who supports government accountability &amp; women&#8217;s safety should support this case. Women deserve an FDA that watches out for THEIR health\u2014not the health of the abortion industry.&#8221;<\/p>\n<p style=\"text-align: center;\"><a href=\"https:\/\/actnow.io\/ARQQhk1\"><b><i>The DOJ put a pro-life grandmother in jail for protesting the killing of preborn children. Please take 30-seconds to TELL CONGRESS: STOP THE DOJ FROM TARGETING PRO-LIFE AMERICANS.<\/i><\/b><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>An abortion pill lawsuit set to be heard before the United States Supreme Court on March 26, 2024, will not result in the removal of the drug from the market, as some have suggested. Here&#8217;s what you need to know&#8230; FACT: Abortion drugs have been available since approval in 2000 and will continue to be [&hellip;]<\/p>\n","protected":false},"author":303,"featured_media":268238,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false},"categories":[9953,9459],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Separating fact from fiction in the Supreme Court&#039;s upcoming abortion pill case<\/title>\n<meta name=\"description\" content=\"&quot;We\u2019re asking for the restoration of basic safety standards the FDA illegally removed, like in-person doctor visits,&quot;said ADF.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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