{"id":243306,"date":"2021-04-13T12:18:48","date_gmt":"2021-04-13T17:18:48","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=243306"},"modified":"2021-04-13T22:05:08","modified_gmt":"2021-04-14T03:05:08","slug":"fda-letter-permits-abortion-pill-by-mail-during-the-covid-19","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/fda-letter-permits-abortion-pill-by-mail-during-the-covid-19\/","title":{"rendered":"FDA to allow abortion pill distribution by mail during COVID-19 pandemic"},"content":{"rendered":"<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div><p>A\u00a0<a href=\"https:\/\/www.sba-list.org\/wp-content\/uploads\/2021\/04\/govdoc20210412-226601.pdf\">letter<\/a> sent by the U.S. Food and Drug Administration (FDA) to the pro-abortion American College of Obstetrics and Gynecology (ACOG) indicates that the agency plans to &#8220;exercise enforcement discretion&#8221; in the dispensing of the abortion pill by mail during the COVID-19 pandemic. In other words, the FDA intends to continue to allow the distribution of these dangerous abortion drugs by mail for the duration of the pandemic.<\/p>\n<p>The decision follows ongoing <a href=\"https:\/\/www.vice.com\/en_us\/article\/935yq7\/trumps-fda-wont-let-women-get-abortion-pills-remotely-in-a-pandemic-so-the-aclu-is-suing\" target=\"_blank\" rel=\"noopener\">litigation<\/a> filed by\u00a0ACOG against the FDA asserting that requiring mifepristone (the abortion pill) to be dispensed to abortion clients <em>in person<\/em> during the COVID-19 pandemic is an undue burden.\u00a0Under FDA\u2019s REMS (<a href=\"https:\/\/www.fda.gov\/aboutfda\/transparency\/basics\/ucm325201.htm\" target=\"_blank\" rel=\"noopener\">Risk Evaluation and Mitigation Strategy<\/a>), the abortion pill mifepristone (used in a regimen with misoprostol) must be dispensed by a certified prescriber at an approved hospital or clinic and is prohibited from being sold online or in a pharmacy.<\/p>\n<div class=\"video-container\">\n<blockquote class=\"twitter-tweet\" data-width=\"550\" data-dnt=\"true\">\n<p lang=\"en\" dir=\"ltr\">BREAKING: ACOG win! The <a href=\"https:\/\/twitter.com\/US_FDA?ref_src=twsrc%5Etfw\">@US_FDA<\/a> Acting Commissioner Janet Woodcock has notified <a href=\"https:\/\/twitter.com\/acog?ref_src=twsrc%5Etfw\">@ACOG<\/a> and <a href=\"https:\/\/twitter.com\/MySMFM?ref_src=twsrc%5Etfw\">@MySMFM<\/a> that the agency will &quot;exercise enforcement discretion&quot; regarding <a href=\"https:\/\/twitter.com\/hashtag\/mifepristone?src=hash&amp;ref_src=twsrc%5Etfw\">#mifepristone<\/a> through the duration of the <a href=\"https:\/\/twitter.com\/hashtag\/COVID19?src=hash&amp;ref_src=twsrc%5Etfw\">#COVID19<\/a> public health emergency. 1\/ <a href=\"https:\/\/t.co\/PDpJ7000bc\">pic.twitter.com\/PDpJ7000bc<\/a><\/p>\n<p>&mdash; ACOG Action (@ACOGAction) <a href=\"https:\/\/twitter.com\/ACOGAction\/status\/1381781110980501512?ref_src=twsrc%5Etfw\">April 13, 2021<\/a><\/p><\/blockquote>\n<p><script async src=\"https:\/\/platform.twitter.com\/widgets.js\" charset=\"utf-8\"><\/script><\/div>\n<p>Live Action News has\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/abortion-industry-covid-19-expand-2020\/\" target=\"_blank\" rel=\"noopener\">previously<\/a> documented how the abortion industry used the COVID-19 pandemic to lift the REMS and expand access to the abortion pill. In fact,\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/no-test-contact-abortion-covid-works-time\/\">well before<\/a>\u00a0the pandemic, the industry\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/abortion-pill-trial-expands-thwart-fda-safety\/\">expanded<\/a>\u00a0its abortion pill clinical trials and then\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/alarming-abortion-pill-ultrasounds-guess\/\" target=\"_blank\" rel=\"noopener\">rolled out<\/a> a \u201c<a href=\"https:\/\/archive.liveaction.org\/news\/no-test-abortion-pill-protocol-access-safety\/\" target=\"_blank\" rel=\"noopener\">no test<\/a>\u201d abortion pill protocol, which <a href=\"https:\/\/archive.liveaction.org\/news\/obgyn-no-test-abortion-pill-experiments-women\/\">some medical professionals have said<\/a> endangers women. Around the same time frame, the ACOG also\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/acog-updates-recommendations-abortion-industry\/\" target=\"_blank\" rel=\"noopener\">changed<\/a> its recommendations to line up exactly with the abortion industry\u2019s attempts to expand access to the abortion pill.<\/p>\n<p>The ACOG is not an impartial medical organization; it is radically\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/american-college-obstetricians-gynecologists-pro-abortion\/\" target=\"_blank\" rel=\"noopener\">pro-abortion.<\/a>\u00a0It has been\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/acog-updates-recommendations-abortion-industry\/\" target=\"_blank\" rel=\"noopener\">funded<\/a>\u00a0by <a href=\"https:\/\/ibisreproductivehealth.org\/sites\/default\/files\/files\/publications\/Ibis%202016%20990.pdf\" target=\"_blank\" rel=\"noopener\">organizations<\/a> that directly received\u00a0<a href=\"https:\/\/web.archive.org\/web\/20200130190128\/https:\/\/ibisreproductivehealth.org\/funders\">funds<\/a>\u00a0from U.S. abortion pill manufacturer Danco Laboratories. ACOG is also <a href=\"https:\/\/ibisreproductivehealth.org\/funders\">funded<\/a>\u00a0by the David and Lucile Packard Foundation, a Danco investor.\u00a0In 2018, the ACOG\u00a0<a href=\"https:\/\/www.grantmakers.io\/profiles\/v0\/476032365-susan-thompson-buffett-foundation\/?query=American%20College%20of%20Obstetrics\" target=\"_blank\" rel=\"noopener\">received<\/a>\u00a0$1.4 million from the Buffett Foundation \u2014 a known abortion philanthropist \u2014and has received hundreds of thousands from the foundation every year for the\u00a0<a href=\"http:\/\/990s.foundationcenter.org\/990pf_pdf_archive\/476\/476032365\/476032365_201612_990PF.pdf\" target=\"_blank\" rel=\"noopener\">past<\/a>\u00a0several years. Buffett was also one of the first\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/study-funded-abortion-pill-investor-buffett-foundation\/\" target=\"_blank\" rel=\"noopener\">investors<\/a>\u00a0in\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/secrecy-abortion-pill-maker-investors\/\" target=\"_blank\" rel=\"noopener\">Danco<\/a>.<\/p>\n<p>The\u00a0<a href=\"https:\/\/twitter.com\/ACOGAction\/status\/1381781110980501512\" target=\"_blank\" rel=\"noopener\">letter<\/a>\u00a0was sent by Janet Woodcock, Acting Commissioner of the FDA under the Biden administration who\u00a0<a href=\"https:\/\/web.archive.org\/web\/20100120053521\/https:\/\/www.fda.gov\/NewsEvents\/Testimony\/ucm112562.htm\" target=\"_blank\" rel=\"noopener\">previously<\/a>\u00a0served as Director of the FDA\u2019s Center for Drug Evaluation and Research (CDER)\u00a0when the Agency approved the abortion pill.<\/p>\n<div id=\"attachment_243310\" style=\"width: 1691px\" class=\"wp-caption aligncenter\"><img aria-describedby=\"caption-attachment-243310\" decoding=\"async\" loading=\"lazy\" class=\"wp-image-243310 size-full\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2021\/04\/FDA-letter-to-ACOG-abortion-pill-Rems-COVID-Image-Twitter.jpg\" alt=\"Image: FDA letter to ACOG allows dispensing of abortion pill by mail outside Rems during COVID-19Image Twitter\" width=\"1681\" height=\"1167\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2021\/04\/FDA-letter-to-ACOG-abortion-pill-Rems-COVID-Image-Twitter.jpg 1681w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2021\/04\/FDA-letter-to-ACOG-abortion-pill-Rems-COVID-Image-Twitter-300x208.jpg 300w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2021\/04\/FDA-letter-to-ACOG-abortion-pill-Rems-COVID-Image-Twitter-768x533.jpg 768w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2021\/04\/FDA-letter-to-ACOG-abortion-pill-Rems-COVID-Image-Twitter-700x486.jpg 700w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2021\/04\/FDA-letter-to-ACOG-abortion-pill-Rems-COVID-Image-Twitter-500x347.jpg 500w\" sizes=\"(max-width: 1681px) 100vw, 1681px\" \/><p id=\"caption-attachment-243310\" class=\"wp-caption-text\">FDA letter to ACOG allows dispensing of abortion pill by mail outside Rems during COVID-19 Image Twitter<\/p><\/div>\n<p>In the letter, Woodcock claims that\u00a0CDER reviewed &#8220;postmarketing adverse events that reportedly occurred from January 27, 2020 &#8211; January 12, 2021&#8221; and found the &#8220;small number of adverse events reported to FDA during the COVID-19 public health emergency (PHE) provided no indication that any program deviation or noncompliance with the Mifepristone REMS contributed to the reported adverse events.&#8221;<\/p>\n<p>What Woodcock failed to note is that\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2016\/020687Orig1s020RemsR.pdf\">changes<\/a>\u00a0made to the <a href=\"https:\/\/archive.liveaction.org\/news\/abortion-pill-dangerous-safety-requirement\/\" target=\"_blank\" rel=\"noopener\">REMS<\/a> by the FDA in 2016 <strong>no longer required the manufacturer of the abortion pill,\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/secrecy-abortion-pill-maker-investors\/\">Danco<\/a>\u00a0Laboratories or its generic GenBioPro to\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/pro-abortion-men-legalize-expand-abortion\/\">report<\/a><\/strong><i><strong>\u00a0non-fatal adverse effects<\/strong>.\u00a0<\/i><\/p>\n<p>The letter also indicates that CDER reviewed at least four studies published around the dispensing of the abortion pill via telemedicine. One of those &#8220;studies&#8221; was based on a\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/abortion-pill-trial-expands-thwart-fda-safety\/\" target=\"_blank\" rel=\"noopener\">TelAbortion Project<\/a> sponsored by Gynuity Health Projects. Live Action News has <a href=\"https:\/\/archive.liveaction.org\/news\/abortion-industry-financial-conflicts-interest-politicians-media\/\" target=\"_blank\" rel=\"noopener\">previously<\/a> documented the funding streams and conflicts of interest surrounding multiple abortion pill studies like this one.<\/p>\n<p>The letter made clear that the FDA planned to &#8220;exercise enforcement discretion&#8221; with respect to in-person requirements as well as the dispensing of the abortion pill through the mail.<\/p>\n<p style=\"padding-left: 30px;\"><em>Provided the other requirements of the Mifepristone REMS are met and given that the in-person dispensing of mifepristone&#8230; may present additional COVID-related risks to patients and healthcare personnel&#8230; CDER intends to exercise enforcement discretion during the COVID-19 PHE with respect to the in-person dispensing requirement&#8230; [and] with respect to the dispensing of mifepristone through the mail either by or under the supervision of a certified prescriber or through a mail order pharmacy when such dispensing is done under the supervision of a certified prescriber.<\/em><\/p>\n<p>SBA List president Marjorie Dannenfelser <a href=\"https:\/\/www.sba-list.org\/category\/newsroom\/press-releases\">called<\/a> the FDA&#8217;s decision &#8220;pure politics,&#8221; adding, &#8220;The Biden-Harris FDA is acting in the financial interest of the big abortion lobby. This is flagrant and dangerous disregard for the health and safety of American women and girls.\u201d<u><\/u><u><\/u><\/p>\n<p>In a press release, Live Action founder and president Lila Rose said:<\/p>\n<p dir=\"ltr\" style=\"padding-left: 30px;\"><em>Because of today\u2019s decision, women will be home alone delivering a dead child, unsure whether the volume of blood loss they see is \u2018normal\u2019 for the abortion procedure or them hemorrhaging and bleeding out. Unsure if the pain they feel is the \u2018normal\u2019 pain of the abortion procedure or pain from their ectopic pregnancy going undiagnosed and now threatening their life. Now, due to the utter carelessness of the FDA, the door has been opened for sexual predators to have the abortion pill delivered by mail so they can administer it to their victims and destroy the evidence of their sexual crimes.<\/em><\/p>\n<p dir=\"ltr\" style=\"padding-left: 30px;\"><em>The FDA is out of line and the American people should respond en masse calling for them to pull the pill. In a move showing blatant disdain for the intellect of the American people, <a href=\"http:\/\/link.mediaoutreach.meltwater.com\/ls\/click?upn=pGDxhfazC1banfHducPByf1RT0AuMa0T5Zv80jRroBvbrJuUEjYW1r0dYyHkddPjtJlnR-2BX7LqpyUNs-2BuFkV6VDX1xyFEssXz7Q50oAIX-2FOP8n06v0E0-2FErDNUgZQtdK3OK9_d-2FLe5v76E6o0ErB1Db-2B6wCVeU92O3q0iNJUoeUdWO3zLDHLvu5cDx9syWigVXuntKOJ7grvhj7d5uVj7OxI-2Fb7CN3o2KlXu6VwI4RwPxJFwJmLMTGJtEAjez2vUJP4rLgGOiQIZAvutE-2Bv4HO1mJxfgUFCyMFVi64mZdg7c5Z7x0vIN1pgg3kWyKS2vjeWAFmKzb1MYipdMljMfjdgo7xLSmVOWDsq-2FBs8tOP-2Fig0c8mF3lR5jPcE-2B5-2FbV2ohjMkKYRcxupp9ZbtkkTRvXEdmFgmB3o7l9roE0wyEmjhBIuq-2BC2f36CbRiZRf-2FX7kcCjxqsAc3bUW8viUnvJLT13Xs8yI8pk7XogTLNB6U6RFyGS8GDZIjsB6h2fUjLz33cylR3YWWzJdRhSHRuhZn0liQ-3D-3D\" target=\"_blank\" rel=\"noopener\" data-saferedirecturl=\"https:\/\/www.google.com\/url?q=http:\/\/link.mediaoutreach.meltwater.com\/ls\/click?upn%3DpGDxhfazC1banfHducPByf1RT0AuMa0T5Zv80jRroBvbrJuUEjYW1r0dYyHkddPjtJlnR-2BX7LqpyUNs-2BuFkV6VDX1xyFEssXz7Q50oAIX-2FOP8n06v0E0-2FErDNUgZQtdK3OK9_d-2FLe5v76E6o0ErB1Db-2B6wCVeU92O3q0iNJUoeUdWO3zLDHLvu5cDx9syWigVXuntKOJ7grvhj7d5uVj7OxI-2Fb7CN3o2KlXu6VwI4RwPxJFwJmLMTGJtEAjez2vUJP4rLgGOiQIZAvutE-2Bv4HO1mJxfgUFCyMFVi64mZdg7c5Z7x0vIN1pgg3kWyKS2vjeWAFmKzb1MYipdMljMfjdgo7xLSmVOWDsq-2FBs8tOP-2Fig0c8mF3lR5jPcE-2B5-2FbV2ohjMkKYRcxupp9ZbtkkTRvXEdmFgmB3o7l9roE0wyEmjhBIuq-2BC2f36CbRiZRf-2FX7kcCjxqsAc3bUW8viUnvJLT13Xs8yI8pk7XogTLNB6U6RFyGS8GDZIjsB6h2fUjLz33cylR3YWWzJdRhSHRuhZn0liQ-3D-3D&amp;source=gmail&amp;ust=1618431290891000&amp;usg=AFQjCNFw4nGewGE6fJzSI77wUIzCtc55kg\">today\u2019s letter<\/a> from the FDA claims that the \u2018small number of adverse events reported to the FDA during the COVID-19 public health emergency\u2019 led to their decision. <\/em><\/p>\n<p dir=\"ltr\" style=\"padding-left: 30px;\"><em>In reality, there is no requirement for the manufacturer of the pill, Danco Laboratories, or its generic, GenBioPro, to report any adverse reactions except death under REMS since 2016. In addition, there are no federal laws in place to require or track abortion complications across all states.\u00a0<\/em><\/p>\n<p>In\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/california-pharmacy-first-us-ship-abortion-pill\/\">October of 2020<\/a>, the first U.S. online pharmacy announced plans to ship abortion pills to patients across the country during COVID-19. Shortly thereafter, virtual abortion pill dispensaries began to\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/buyer-beware-virtual-abortion-pill-websites-pandemic\/\" target=\"_blank\" rel=\"noopener\">flood<\/a>\u00a0the internet.<\/p>\n<p>While the latest changes to FDA&#8217;s REMS are only in effect during the pandemic, the Biden-Harris administration is expected to pressure the FDA to <strong>permanently<\/strong> remove the REMS from the abortion pill. If this occurs, it will likely result in a surge of abortion pill sales far beyond the previously <a href=\"https:\/\/archive.liveaction.org\/news\/industry-making-killing-abortion-pill-sales\/\">estimated<\/a>\u00a0$200 million annually.<\/p>\n<p><em>Editor&#8217;s Note:\u00a0Visit <a href=\"http:\/\/reverseabortionpill.com\">AbortionPillReversal.com<\/a> for information on how to potentially stop the abortion pill process after it has begun.<\/em><\/p>\n<p style=\"text-align: center;\"><em><strong><a href=\"https:\/\/www.facebook.com\/liveactionnewsonline\/\" target=\"_blank\" rel=\"noopener\">\u201cLike\u201d Live Action News on Facebook<\/a>\u00a0for more pro-life news and commentary!<\/strong><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A\u00a0letter sent by the U.S. Food and Drug Administration (FDA) to the pro-abortion American College of Obstetrics and Gynecology (ACOG) indicates that the agency plans to &#8220;exercise enforcement discretion&#8221; in the dispensing of the abortion pill by mail during the COVID-19 pandemic. In other words, the FDA intends to continue to allow the distribution of [&hellip;]<\/p>\n","protected":false},"author":303,"featured_media":223707,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false},"categories":[9953,3473,9459],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA issues letter allowing abortion pill by mail during COVID-19 pandemic<\/title>\n<meta name=\"description\" content=\"The FDA announced that it intends to continue to allow the distribution of the abortion pill by mail for the duration of the COVID-19 pandemic.\" \/>\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\/fda-letter-permits-abortion-pill-by-mail-during-the-covid-19\/\" \/>\n<meta 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