{"id":292889,"date":"2023-06-12T08:39:09","date_gmt":"2023-06-12T13:39:09","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=292889"},"modified":"2023-06-09T23:48:28","modified_gmt":"2023-06-10T04:48:28","slug":"businesses-fda-abortion-pill-safety-requirements","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/businesses-fda-abortion-pill-safety-requirements\/","title":{"rendered":"Abortion businesses ask judge to remove FDA&#8217;s abortion pill safety requirements"},"content":{"rendered":"<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div><p>(<a href=\"https:\/\/www.nationalrighttolifenews.org\/2023\/06\/abortion-clinics-ask-judge-to-protect-them-from-safety-requirements-intended-to-protect-women-that-go-back-over-20-years-2\/\">NRL News Today<\/a>) District Judge Robert S. Ballou heard arguments Thursday from lawyers representing abortion clinics in three states \u2013 Virginia, Montana, and Kansas \u2014 asking him to shield them from further limitations on their use of mifepristone, one half of the two-drug chemical abortion techniques. They are asking the judge to force the FDA to drop several longstanding restrictions on how mifepristone can be prescribed.<\/p>\n<p>\u201cSpecifically, providers want the FDA and U.S. Department of Health and Human Services to abandon the set of restrictions known as a Risk Evaluation and Mitigation Strategy (\u201cREMS\u201d), which has applied to mifepristone since it was approved 23 years ago,\u201d\u00a0<a href=\"https:\/\/www.vpm.org\/news\/2023-06-08\/charlottesville-abortion-mifepristone-access-virginia-montana-kansas\">according to Whittney Evans<\/a>. \u201cREMS regulates mifepristone in a similar way to chemotherapy drugs, which providers argue is unnecessary and misleading.\u201d<\/p>\n<p>What the providers ultimately want \u201cis for the federal government to remove the REMS designation entirely,\u201d Evans continued. \u201cIn the meantime, they\u2019ve asked District Judge Robert S. Ballou for a preliminary injunction to prevent further restrictions and maintain the status quo.\u201d<\/p>\n<p>In a different case now working its way through the courts, pro-life plaintiffs in\u00a0<em>Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration<\/em>\u00a0(FDA) expressed a radically different view.<\/p>\n<p>They argued that the FDA unlawfully fast-tracked the approval of mifepristone through a process intended for the treatment of life-threatening illnesses.<\/p>\n<p style=\"text-align: center;\"><iframe loading=\"lazy\" title=\"YouTube video player\" src=\"https:\/\/www.youtube.com\/embed\/gnEHZiud8dg\" width=\"640\" height=\"315\" 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>\n<\/p>\n<p>In that case,\u00a0District Judge Matthew Kacsmaryk\u00a0<a href=\"https:\/\/www.nationalrighttolifenews.org\/2023\/04\/judge-kacsmaryk-harshly-criticizes-fda-for-its-handling-of-chemical-abortions-issues-preliminary-ruling-invalidating-fda-approval\">issued a national injunction<\/a>\u00a0on April\u00a08th\u00a0on the use of mifepristone in chemical abortions.\u00a0On April 21, the U.S. Supreme Court released a decision that\u00a0<a href=\"https:\/\/www.nationalrighttolifenews.org\/2023\/04\/supreme-court-stays-lower-court-ruling-returns-abortion-pill-controversy-to-the-5th-circuit\" target=\"_blank\" rel=\"noreferrer noopener\">stayed lower court rulings and returned the issue to the 5th Circuit<\/a>.<\/p>\n<p>The pro-abortion plaintiffs argue that\u00a0mifepristone has been used safely and effectively for more than two decades. \u201c[By] making mifepristone seem uniquely dangerous, FDA\u2019s continuing restriction of mifepristone stigmatizes medication abortion and contributes to the chaos anti-abortion activists now sow,\u201d according to the lawsuit. \u201cPlaintiffs are continuously facing the weaponization of the REMS by anti-abortion activists around the country.\u201d<\/p>\n<p><a href=\"https:\/\/www.liveaction.org\/target-petition\/?utm_source=lan&amp;utm_medium=display&amp;utm_campaign=lan_website&amp;utm_content=target_petition\"><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter size-large wp-image-292702\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/06\/LA23MAY_TargetPetition_resized-700x180.jpg\" alt=\"Target petition\" width=\"700\" height=\"180\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/06\/LA23MAY_TargetPetition_resized-700x180.jpg 700w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/06\/LA23MAY_TargetPetition_resized-300x77.jpg 300w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/06\/LA23MAY_TargetPetition_resized-768x198.jpg 768w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/06\/LA23MAY_TargetPetition_resized-500x129.jpg 500w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/06\/LA23MAY_TargetPetition_resized.jpg 1200w\" sizes=\"(max-width: 700px) 100vw, 700px\" \/><\/a><\/p>\n<p>Indeed, the Department of Justice and Danco\u00a0Laboratories (which manufactures mifepristone) went so far as to insist that complication rate for women who take\u00a0<a href=\"http:\/\/www.cnn.com\/2023\/01\/06\/health\/medication-abortion-process-wellness\/index.html\" target=\"_blank\" rel=\"noreferrer noopener\">mifepristone<\/a> is miniscule \u2014 less than one percent.<\/p>\n<p>But Dr. Randall O\u2019Bannon, director of Education &amp; Research, has cited studies proving that the percentage is much, much higher. (See\u00a0<a href=\"https:\/\/www.nrlc.org\/uploads\/factsheets\/RUSafetyEfficacyFS.pdf%20%5d%20and%20here%20%5bhttps:\/www.nrlc.org\/wp-content\/uploads\/23-0404-White-Paper-Myths-About-the-FDA-Approval-of-Mifepristone.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">here<\/a>.)<\/p>\n<p>He told me \u201cBut the\u00a0<em>coup de grace<\/em>\u00a0is probably just exactly what the Alliance for Hippocratic Medicine attorney Erin Hawley cited \u2014 the FDA itself, pointing to Table 2 of the 2023 label itself, which\u00a0showed ER Visits to be between 2.9%-4.6%.<\/p>\n<p>On April 5, National Right to Life released a white paper about the myths involving the Food and Drug Administration\u2019s (FDA) approval and management of mifepristone (generic for Mifeprex), accurately anticipating and answering many of the issues that have been raised in coverage of the case.<\/p>\n<p>Meanwhile,\u00a0in a third case similar to the one just heard by Ballou,\u00a0a federal judge in Washington state came to a dramatically different\u00a0conclusion.\u00a0Judge Thomas O. Rice\u2019s ruling compels the FDA not to do anything that might affect the availability of\u00a0mifepristone in the 17 states (and the District of Columbia) with Democrat attorneys general who have sued. They argued\u00a0that too many regulations already exist on the drug.<\/p>\n<p><em>Editor&#8217;s Note: This article was published at <a href=\"https:\/\/www.nationalrighttolifenews.org\/2023\/06\/abortion-clinics-ask-judge-to-protect-them-from-safety-requirements-intended-to-protect-women-that-go-back-over-20-years-2\/\">NRL News Today<\/a> and is reprinted here with permission.<\/em><\/p>\n<p style=\"text-align: center;\"><a href=\"https:\/\/give.liveaction.org\/general-donation\/?utm_source=lan&amp;utm_medium=display&amp;utm_campaign=monthly&amp;utm_content=article\"><i><strong>Did you know that as little as $10 a month is enough to reach more than 3,000 people with the truth about abortion that no one else is telling them? Click here to start saving lives 365 days a year.<\/strong><\/i><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>(NRL News Today) District Judge Robert S. Ballou heard arguments Thursday from lawyers representing abortion clinics in three states \u2013 Virginia, Montana, and Kansas \u2014 asking him to shield them from further limitations on their use of mifepristone, one half of the two-drug chemical abortion techniques. They are asking the judge to force the FDA [&hellip;]<\/p>\n","protected":false},"author":322,"featured_media":270581,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false},"categories":[7077],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Abortion businesses ask judge to remove FDA&#039;s abortion pill safety requirements<\/title>\n<meta name=\"description\" content=\"Abortionists &quot;want the FDA and [HHS] to abandon&quot; the REMS safety protocols, which have applied to mifepristone for 23 years.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/archive.liveaction.org\/news\/businesses-fda-abortion-pill-safety-requirements\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta 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