{"id":289128,"date":"2023-04-14T06:42:35","date_gmt":"2023-04-14T11:42:35","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=289128"},"modified":"2023-04-14T05:23:19","modified_gmt":"2023-04-14T10:23:19","slug":"fda-abortion-pill-timeline-events","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/fda-abortion-pill-timeline-events\/","title":{"rendered":"The FDA and the abortion pill: A timeline of key events"},"content":{"rendered":"<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div><p>With the spotlight on the abortion pill (mifepristone) as the courts wrangle over the legitimacy of the U.S. Food and Drug Administration&#8217;s original approval of the drug, Live Action News has put together a timeline on the process from its beginnings to today. An estimated <a href=\"https:\/\/archive.liveaction.org\/news\/us-abortion-pill-lives-lost-adverse-obscured\/\">5.6 million human lives<\/a> have been ended through the use of this drug, which also comes with potentially serious side effects for women.<\/p>\n<h2>Background<\/h2>\n<p>The abortion pill (mifepristone) is sold in the United States under the brand name Mifeprex and was originally invented and patented in 1980 by the French pharmaceutical company <a href=\"https:\/\/archive.liveaction.org\/news\/connection-abortion-pill-zyklonb-gas-holocaust\/\" target=\"_blank\" rel=\"noopener\">Roussel-Uclaf<\/a>, a subsidiary of Germany\u2019s Hoechst AG. It\u00a0was approved for sale in the United States in September of 2000,\u00a0with specific\u00a0<a href=\"https:\/\/web.archive.org\/web\/20150622014105\/https:\/\/www.accessdata.fda.gov\/scripts\/cder\/rems\/index.cfm?event=IndvRemsDetails.page&amp;REMS=35\" target=\"_blank\" rel=\"noopener\">restrictions<\/a>\u00a0that it\u00a0<i>not<\/i>\u00a0be shipped directly to women but be\u00a0<a href=\"https:\/\/www.fda.gov\/Drugs\/DrugSafety\/PostmarketDrugSafetyInformationforPatientsandProviders\/ucm111323.htm\">administered<\/a>\u00a0by certified prescribers at a clinic or hospital where follow-up care would be available.<\/p>\n<p style=\"text-align: center;\"><iframe loading=\"lazy\" title=\"YouTube video player\" src=\"https:\/\/www.youtube.com\/embed\/1YuYvyIGWlM\" 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<h2>Timeline<\/h2>\n<p><strong>PRE-APPROVAL (1994)<\/strong>: In 1994, with the\u00a0<a href=\"https:\/\/archive.hhs.gov\/news\/press\/1994pres\/940516.txt\">encouragement<\/a>\u00a0of the Clinton administration, Roussel-Uclaf assigned the\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/appletter\/2000\/20687appltr.pdf\">U.S. rights<\/a>\u00a0of marketing and\u00a0<a href=\"http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/PostmarketDrugSafetyInformationforPatientsandProviders\/ucm086149.pdf\" target=\"_blank\" rel=\"noopener\">distribution<\/a>\u00a0of the abortion pill (known then as RU-486) to the eugenics-founded\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/population-council-founded-eugenicists-promoting-abortion-turns-65\/\" target=\"_blank\" rel=\"noopener\">Population Council<\/a>. The right to distribute the drugs was\u00a0<a href=\"http:\/\/www.nytimes.com\/2000\/09\/30\/us\/abortion-pill-distributor-energized-by-new-mission.html\">later<\/a>\u00a0handed over to Danco Laboratories, a\u00a0<a href=\"http:\/\/caselaw.findlaw.com\/ny-supreme-court-appellate-division\/1151610.html\">sub-licensee<\/a>\u00a0of the Population Council.\u00a0Then, by\u00a0<strong>1996<\/strong>, the Population Council (funded in part with <a href=\"https:\/\/twitter.com\/CaroleNovielli\/status\/1628441678490005509\" target=\"_blank\" rel=\"noopener\">investments<\/a> from the Buffett and Packard Foundations) submitted its <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2000\/20687_Mifepristone_approvableltr.pdf\" target=\"_blank\" rel=\"noopener\">application<\/a> for the drug to the FDA, and a series of clinical trials began.<\/p>\n<p><strong>U.S. APPROVAL (2000)<\/strong>: In 2000,\u00a0following those clinical trials, the U.S. FDA <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/appletter\/2000\/20687appltr.pdf\" target=\"_blank\" rel=\"noopener\">approved<\/a>\u00a0mifepristone as an abortion pill for use\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2011\/020687s014lbl.pdf\" target=\"_blank\" rel=\"noopener\">up to 7 weeks of pregnancy<\/a> in a regimen along with the drug misoprostol.<\/p>\n<p><strong>SAFETY RULES ADDED (2011)<\/strong>: In 2011, the\u00a0FDA made the decision to place the drug under its <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/rems\/Mifepristone_2019_04_11_REMS_Document.pdf\" target=\"_blank\" rel=\"noopener\">REMS safety system<\/a>, but not before <a href=\"https:\/\/archive.liveaction.org\/news\/abortion-pill-dangerous-safety-requirement\/\" target=\"_blank\" rel=\"noopener\">multiple women had died<\/a> in association with use of the abortion pill regimen.<\/p>\n<p><strong>OBAMA ADMIN WEAKENS FDA SAFETY RULES (2016)<\/strong>: Just <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2016\/020687s020lbl.pdf\" target=\"_blank\" rel=\"noopener\">five years later<\/a>, in 2016, the Obama administration FDA <a href=\"https:\/\/archive.liveaction.org\/news\/biden-fda-commissioner-expanded-abortion-pill-obama\/\" target=\"_blank\" rel=\"noopener\">weakened the REMS<\/a>\u00a0by <em>removing<\/em> the requirements that women or teen girls take the first drug in front of a clinician, in-person at the location of a certified prescriber and that the manufacturer report the drug&#8217;s <em>non-fatal adverse events <\/em>(complications). The drug&#8217;s allowed use was also extended for use on preborn children up to\u00a0<a href=\"https:\/\/babyolivia.liveaction.org\/assets\/img\/Download-Bundle\/Week-7\/Olivia-Week07-3.jpg\" target=\"_blank\" rel=\"noopener\">10 weeks (70 days)<\/a>\u00a0of pregnancy.<\/p>\n<p><strong>GENERIC MANUFACTURER APPROVED (2019)<\/strong>: In 2019,\u00a0the FDA approved <a href=\"https:\/\/archive.liveaction.org\/news\/generic-abortion-pill-genbiopro-nationwide-market\/\" target=\"_blank\" rel=\"noopener\">GenBioPro<\/a> to become the <a href=\"https:\/\/archive.liveaction.org\/news\/women-die-abortion-pill-fda-generic\/\" target=\"_blank\" rel=\"noopener\">generic manufacturer<\/a> of mifepristone.<\/p>\n<p><strong>ABORTION INDUSTRY &#8216;NO-TEST&#8217; PROTOCOL (2020)<\/strong>: In\u00a02020, the abortion industry rolled out a &#8216;<a href=\"https:\/\/archive.liveaction.org\/news\/no-test-abortion-pill-protocol-access-safety\/\">no-test<\/a>&#8216; abortion pill protocol which removed important labs, testing, and blood work needed to accurately date a pregnancy and <a href=\"https:\/\/archive.liveaction.org\/news\/bad-actors-abortion-pill-fda-ectopic\/\" target=\"_blank\" rel=\"noopener\">rule out<\/a> deadly ectopic pregnancies before administering the abortion pill. Rapid expansion of the abortion pill continued in the ensuing years, even as the abortion industry openly\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/bad-actors-industry-abortion-pill-fda-limits\/\" target=\"_blank\" rel=\"noopener\">flouted FDA gestational limits and safety regulations<\/a>, even encouraging\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/bad-actors-conceal-abortion-pill-complications\/\" target=\"_blank\" rel=\"noopener\">women to lie<\/a> about abortion pill complications.<\/p>\n<p><strong>BIDEN ADMIN WEAKENS SAFETY RULES (2021)<\/strong>: In April of\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/fda-letter-permits-abortion-pill-by-mail-during-the-covid-19\/\" target=\"_blank\" rel=\"noopener\">2021<\/a>, under the guise of the <a href=\"https:\/\/archive.liveaction.org\/news\/abortion-industry-covid-19-expand-2020\/\" target=\"_blank\" rel=\"noopener\">COVID-19 pandemic<\/a>, the Biden administration FDA temporarily enabled abortion pill distribution and <a href=\"https:\/\/archive.liveaction.org\/news\/pharmacy-partnerships-emerge-ship-abortion-pills-mail\/\">expanded<\/a>\u00a0the REMS to limited <a href=\"https:\/\/archive.liveaction.org\/news\/abortion-pill-pharmacy-operates-used-car-dealership\/\">mail-order pharmacy<\/a> <a href=\"https:\/\/archive.liveaction.org\/news\/california-pharmacy-first-us-ship-abortion-pill\/\">distribution<\/a>.\u00a0By\u00a0December of 2021, the Biden FDA had further\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/fda-permanently-loosens-abortion-pill-safety-measure\/\" target=\"_blank\" rel=\"noopener\">weakened<\/a>\u00a0the\u00a0<a href=\"https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/risk-evaluation-and-mitigation-strategies-rems\" target=\"_blank\" rel=\"noopener\">REMS<\/a>\u00a0by eliminating the <a href=\"https:\/\/archive.liveaction.org\/news\/fda-removes-abortion-pill-safety-protocols-drug\/\" target=\"_blank\" rel=\"noopener\">in-person dispensing requirement<\/a>\u00a0and enabling the abortion pill to be permanently\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/fda-permanently-loosens-abortion-pill-safety-measure\/\" target=\"_blank\" rel=\"noopener\">shipped by mail<\/a>.<\/p>\n<p><strong>LAWSUIT CHALLENGES FDA APPROVAL (2022)<\/strong>: The following year (2022) saw key a legal challenge, when in November, the\u00a0Alliance Defending Freedom\u00a0<a href=\"https:\/\/adfmedia.org\/case\/alliance-hippocratic-medicine-v-us-food-and-drug-administration#:~:text=Alliance%20for%20Hippocratic%20Medicine%20v.%20U.S.%20Food%20and,health%2C%20safety%2C%20and%20welfare%20of%20girls%20and%20women.\" target=\"_blank\" rel=\"noopener\">filed<\/a> a <a href=\"https:\/\/adfmedialegalfiles.blob.core.windows.net\/files\/AllianceForHippocraticMedicineComplaint.pdf\" target=\"_blank\" rel=\"noopener\">federal lawsuit<\/a>\u00a0on behalf of the\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/doctors-fda-abortion-pill-decades-medical-negligence\/\" target=\"_blank\" rel=\"noopener\"><em>Alliance for Hippocratic Medicine,<\/em><\/a>\u00a0challenging FDA approval of mifepristone. <span style=\"color: #000000;\">The move followed the FDA&#8217;s unsatisfactory responses to a number of <a style=\"color: #000000;\" href=\"https:\/\/adflegal.org\/article\/clinton-era-fda-action-keeps-women-danger?sourcecode=10027154_r200&amp;utm_source=google&amp;utm_medium=ppc\" target=\"_blank\" rel=\"noopener\">citizen petitions<\/a> the group had submitted.<\/span> That same year,\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/generic-abortion-pill-genbiopro-nationwide-market\/\" target=\"_blank\" rel=\"noopener\">GenBioPro<\/a> (GBP) <a href=\"https:\/\/archive.liveaction.org\/news\/generic-genbiopro-abortion-pill-dismisses-lawsuit-mississippi\/\" target=\"_blank\" rel=\"noopener\">voluntarily dismissed<\/a>\u00a0a lawsuit challenging pro-life legislation in Mississippi.<\/p>\n<p><strong>BIDEN ADMIN FURTHER WEAKENS SAFETY RULES (2023)<\/strong>:\u00a0In January 2023, the Biden FDA further gutted the REMS by announcing it would\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/fda-retail-pharmacies-abortion-pills-prescription\/\" target=\"_blank\" rel=\"noopener\">allow retail pharmacies to dispense the drug<\/a>.\u00a0It was at this time that the FDA officially\u00a0<a href=\"https:\/\/www.fda.gov\/drugs\/postmarket-drug-safety-information-patients-and-providers\/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation#Additional%20Information\" target=\"_blank\" rel=\"noopener\">updated<\/a>\u00a0the drug&#8217;s Post-Marketing Adverse Events Summary to state that \u201cAs of June 30, 2022, there were\u00a0<a href=\"https:\/\/www.fda.gov\/media\/164331\/download\" target=\"_blank\" rel=\"noopener\">28 reports of deaths<\/a>*\u00a0in patients associated with mifepristone since the product was approved in September 2000&#8230;\u201d\u00a0The FDA also documented that between 2000 and June 2022, the abortion pill had <a href=\"https:\/\/archive.liveaction.org\/news\/us-abortion-pill-lives-lost-adverse-obscured\/\">ended the lives<\/a>\u00a0of 5.6 million preborn babies, including over 500,000 in\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/500k-preborn-human-abortion-pill-2020\/\">2020<\/a>\u00a0alone.<\/p>\n<p>Pro-abortion politicians <a href=\"https:\/\/www.atg.wa.gov\/news\/news-releases\/ag-ferguson-challenges-fda-over-unlawful-unnecessary-restrictions-medication\" target=\"_blank\" rel=\"noopener\">filed<\/a> a competing\u00a0<a href=\"https:\/\/agportal-s3bucket.s3.amazonaws.com\/uploadedfiles\/Another\/News\/Press_Releases\/Mifepristone%20PI.pdf\" target=\"_blank\" rel=\"noopener\">lawsuit<\/a>\u00a0(<em>State of Washington v. FDA<\/em>)\u00a0in February,\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/claim-bias-texas-abortion-pill-lawsuit-studies\/\" target=\"_blank\" rel=\"noopener\">requesting<\/a> that the judge enjoin the FDA from (1)\u00a0enforcing or applying the 2023 REMS, and (2) taking any action to remove mifepristone from the market or otherwise cause the drug to become less available\u2026\u201d<\/p>\n<p>By April 7, 2023, U.S. District Court Judge Matthew J. Kacsmaryk had\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/district-court-judge-revoke-fda-abortion-pill\/\" target=\"_blank\" rel=\"noopener\">ruled<\/a>\u00a0in favor of <em>Alliance for Hippocratic Medicine <\/em>to suspend the 2000 approval and subsequent FDA changes to the abortion pill. On the same day, U.S. District Judge Thomas O. Rice\u00a0granted pro-abortion politicians in the Washington State case a preliminary injunction to\u00a0<a href=\"https:\/\/agportal-s3bucket.s3.amazonaws.com\/uploadedfiles\/Another\/News\/Press_Releases\/80_OrderDenyinginPartMotionPI.pdf\">bar the FDA<\/a>\u00a0from \u201caltering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy under 21 U.S.C. \u00a7 355-1 in Plaintiff States.\u201d Just a few days later on April 12, the U.S. Court of Appeals for the Fifth Circuit issued a partial stay in\u00a0<em>Alliance for Hippocratic Medicine. <\/em>While the circuit panel did not suspend the drug&#8217;s 2000 approval, the decision\u00a0<a href=\"https:\/\/storage.courtlistener.com\/recap\/gov.uscourts.ca5.213145\/gov.uscourts.ca5.213145.183.2_1.pdf\" target=\"_blank\" rel=\"noopener\">upheld<\/a>\u00a0the suspension of mail-order abortion pills and\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/fifth-circuit-upholds-abortion-pill-suspension\/\" target=\"_blank\" rel=\"noopener\">reinstated safety requirements<\/a> dated prior to 2016.<\/p>\n<p>Meanwhile, the Biden Administration <a href=\"https:\/\/www.usatoday.com\/story\/news\/politics\/2023\/04\/13\/abortion-biden-supreme-court-pill-mifepristone\/11655611002\/\" target=\"_blank\" rel=\"noopener\">intends<\/a> to ask the United States Supreme Court to intervene. As the nation awaits future court rulings, the abortion industry is already pivoting to a less effective and unapproved <a href=\"https:\/\/archive.liveaction.org\/news\/bad-actors-failure-prone-abortion-drug\/\" target=\"_blank\" rel=\"noopener\">one-drug regimen of misoprostol only<\/a>.<\/p>\n<div id=\"attachment_289068\" style=\"width: 528px\" class=\"wp-caption aligncenter\"><img aria-describedby=\"caption-attachment-289068\" decoding=\"async\" loading=\"lazy\" class=\"size-full wp-image-289068\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/04\/Abortion-pill-changes-2000-to-2023-from-AHM-v-FDA-appeal.jpg\" alt=\"Image: Abortion pill changes 2000 to 2023 from AHM v FDA appeal\" width=\"518\" height=\"725\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/04\/Abortion-pill-changes-2000-to-2023-from-AHM-v-FDA-appeal.jpg 518w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/04\/Abortion-pill-changes-2000-to-2023-from-AHM-v-FDA-appeal-214x300.jpg 214w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/04\/Abortion-pill-changes-2000-to-2023-from-AHM-v-FDA-appeal-500x700.jpg 500w\" sizes=\"(max-width: 518px) 100vw, 518px\" \/><p id=\"caption-attachment-289068\" class=\"wp-caption-text\">Abortion pill changes 2000 to 2023 from AHM v FDA appeal<\/p><\/div>\n<h6>*THE FDA HAS RECEIVED REPORTS OF SERIOUS ADVERSE EVENTS IN PATIENTS WHO TOOK MIFEPRISTONE. AS OF JUNE 30, 2022, THERE WERE 28 REPORTS OF DEATHS IN PATIENTS ASSOCIATED WITH MIFEPRISTONE SINCE THE PRODUCT WAS APPROVED IN SEPTEMBER 2000, INCLUDING TWO CASES OF ECTOPIC PREGNANCY (A PREGNANCY LOCATED OUTSIDE THE WOMB, SUCH AS IN THE FALLOPIAN TUBES) RESULTING IN DEATH; AND SEVERAL FATAL CASES OF SEVERE SYSTEMIC INFECTION (ALSO CALLED SEPSIS). THE ADVERSE EVENTS CANNOT WITH CERTAINTY BE CAUSALLY ATTRIBUTED TO MIFEPRISTONE BECAUSE OF CONCURRENT USE OF OTHER DRUGS, OTHER MEDICAL OR SURGICAL TREATMENTS, CO-EXISTING MEDICAL CONDITIONS, AND INFORMATION GAPS ABOUT PATIENT HEALTH STATUS AND CLINICAL MANAGEMENT OF THE PATIENT. A SUMMARY REPORT OF ADVERSE EVENTS THAT REFLECTS DATA THROUGH JUNE 30, 2022, IS\u202f<a href=\"https:\/\/www.fda.gov\/media\/164331\/download\">HERE<\/a>. THE FDA HAS REVIEWED THIS INFORMATION AND DID NOT IDENTIFY ANY NEW SAFETY SIGNALS. THE FDA INTENDS TO UPDATE THIS SUMMARY REPORT AS APPROPRIATE.<\/h6>\n<p style=\"text-align: center;\"><strong><a href=\"https:\/\/give.liveaction.org\/general-donation\/?utm_source=lan&amp;utm_medium=display&amp;utm_campaign=monthly&amp;utm_content=article\"><i>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.<\/i><\/a><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>With the spotlight on the abortion pill (mifepristone) as the courts wrangle over the legitimacy of the U.S. Food and Drug Administration&#8217;s original approval of the drug, Live Action News has put together a timeline on the process from its beginnings to today. An estimated 5.6 million human lives have been ended through the use [&hellip;]<\/p>\n","protected":false},"author":303,"featured_media":289195,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false},"categories":[9953,15],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>The FDA and the abortion pill: A timeline of key events<\/title>\n<meta name=\"description\" content=\"With the spotlight on the FDA&#039;s approval of the abortion pill in the courts, Live Action News has assembled a timeline of key events up to today.\" \/>\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-abortion-pill-timeline-events\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta 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