Editing Mifepristone (section)

===Legal status===

====In the United States====
Mifepristone was approved for abortion in the United States by the FDA in September 2000.<ref>{{cite web|title=FDA approval letter for Mifepristone| publisher=FDA |date=28 September 2000|access-date=16 September 2006|url=https://www.fda.gov/cder/foi/appletter/2000/20687appltr.htm |archive-url = http://webarchive.loc.gov/all/20011116012552/http%3A//www%2Efda%2Egov/cder/foi/appletter/2000/20687appltr%2Ehtm <!-- Bot retrieved archive --> |archive-date = 16 November 2001 }}</ref> {{As of|2007}}, it was legal and available in all 50 states, Washington, D.C., [[Guam]], and [[Puerto Rico]].<ref>{{cite web|title=Medication Abortion in the United States: Mifepristone Fact Sheet |year=2005 |publisher=Gynuity Health Projects |url=http://www.gynuity.org/documents/mife_fact_sheet.pdf |url-status=dead |archive-url=https://web.archive.org/web/20070924010831/http://www.gynuity.org/documents/mife_fact_sheet.pdf |archive-date=24 September 2007 }}</ref> It is a prescription drug, but was not initially available to the public through pharmacies; its distribution is primarily restricted to specially qualified licensed physicians, sold by [[Danco Laboratories]] under the brand name Mifeprex. As of September 2021, in 32 states, the drug could only be provided by a licensed physician, and in 19 states, the prescribing clinician was required to be physically in the room with the patient while they are taking the drug.<ref name="pmid28094905" />

Roussel Uclaf did not seek US approval, so in the United States legal availability was not initially possible.<ref>{{cite journal| vauthors = Klitsch M |title=Antiprogestins and the abortion controversy: a progress report|journal=Fam Plann Perspect|date=November{{ndash}}December 1991|volume=23|issue=6|pmid=1786809|pages=275–82|doi=10.2307/2135779|jstor=2135779}}</ref> The United States banned importation of mifepristone for personal use in 1989,<ref name=RU486USAevenPersonalUse>{{cite news |work=[[New York Post]] |title=U.S. Grabs Banned Abort Pill From an Activist here | vauthors = Garcilazo M |date=2 July 1992 |page=5}}</ref> a decision supported by Roussel Uclaf. In 1994, Roussel Uclaf gave the U.S. drug rights to the Population Council in exchange for immunity from any product liability claims.<ref name="Seelye 1994"/><ref>{{cite news| vauthors = Gibbs N |title=The Pill Arrives|publisher=Cnn.com|date=2 October 2000|access-date=20 September 2006|url=http://www.cnn.com/ALLPOLITICS/time/2000/10/09/pill.html|url-status=live|archive-url=https://web.archive.org/web/20061006031705/http://www.cnn.com/ALLPOLITICS/time/2000/10/09/pill.html|archive-date=6 October 2006}}</ref> The Population Council sponsored clinical trials in the United States.<ref>{{cite news| vauthors = Lewin T |title=Clinical Trials Giving Glimpse of Abortion Pill|newspaper=The New York Times|date=30 January 1995|access-date=20 September 2006|url=https://query.nytimes.com/gst/fullpage.html?res=990CE6D9173DF933A05752C0A963958260&sec=health&pagewanted=1|url-status=live|archive-url=https://web.archive.org/web/20071128093915/http://query.nytimes.com/gst/fullpage.html?res=990CE6D9173DF933A05752C0A963958260|archive-date=28 November 2007}}</ref> The drug went on approvable status from 1996. Production was intended to begin through the Danco Group in 1996, but they withdrew briefly in 1997 due to a corrupt business partner, delaying availability again.<ref>{{cite news| vauthors = Lewin T |title=Lawsuits' Settlement Brings New Hope for Abortion Pill|newspaper=The New York Times|date=13 November 1997|access-date=16 September 2006|url=https://query.nytimes.com/gst/fullpage.html?sec=health&res=9906E7DB1638F930A25752C1A961958260|url-status=live|archive-url=https://web.archive.org/web/20070210071338/http://query.nytimes.com/gst/fullpage.html?sec=health|archive-date=10 February 2007}}</ref><ref>{{cite web| vauthors = Lerner S |title=RU Pissed Off Yet?|newspaper=The Village Voice|date=August 2000|access-date=16 September 2006|url=http://www.villagevoice.com/news/0035,lerner,17757,1.html|url-status=dead|archive-url=https://web.archive.org/web/20061107151729/http://www.villagevoice.com/news/0035%2Clerner%2C17757%2C1.html|archive-date=7 November 2006}}</ref>

In 2016, the US [[Food and Drug Administration]] (FDA) approved mifepristone, to end a pregnancy through 70 days gestation (70 days or less since the first day of a woman's last menstrual period). The approved dosing regimen is 200&nbsp;mg of mifepristone taken by mouth (swallowed).&nbsp; 24 to 48 hours after taking mifepristone, 800 mcg (micrograms) of misoprostol is taken [[Buccal administration|buccally]] (in the cheek pouch), at a location appropriate for the patient.<ref name="FDA Mifeprex Info 2016"/><ref name="Mifeprex PI 2016">{{cite web|author=Danco Laboratories|date=29 March 2016|title=Mifeprex prescribing information|publisher=U.S. [[Food and Drug Administration]] (FDA)|url=http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020687s020lbl.pdf|url-status=live|archive-url=https://web.archive.org/web/20160330220744/http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020687s020lbl.pdf|archive-date=30 March 2016}}</ref><ref name="ACOG 2016">{{cite web|author=American Congress of Obstetricians and Gynecologists|date=30 March 2016|title=ACOG Statement on Medication Abortion|location=Washington, D.C.|publisher=ACOG|url=http://www.acog.org/About-ACOG/News-Room/Statements/2016/ACOG-Statement-on-Medication-Abortion|access-date=7 April 2016|url-status=live|archive-url=https://web.archive.org/web/20160403194210/http://www.acog.org/About-ACOG/News-Room/Statements/2016/ACOG-Statement-on-Medication-Abortion|archive-date=3 April 2016}}</ref><ref>{{Cite web|url=https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111323.htm|title=Postmarket Drug Safety Information for Patients and Providers|date=30 March 2016|website=US Food & Drug Administration|access-date=16 October 2017|archive-date=3 April 2016|archive-url=https://web.archive.org/web/20160403194206/https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111323.htm|url-status=live}}</ref>

Mifepristone tablets have a marketing authorization in the United States for the treatment of high blood sugar caused by high [[cortisol]] levels in the blood (hypercortisolism) in adults with [[Cushing's syndrome#Exogenous vs. endogenous|endogenous]] [[Cushing's syndrome]] who have [[diabetes mellitus type 2|type 2 diabetes mellitus]] or [[impaired glucose tolerance|glucose intolerance]] and have failed surgery or cannot have surgery.<ref name="Korlym FDA label"/>

Due to the [[COVID-19 pandemic]], safe access to mifepristone was a concern, and the [[American College of Obstetricians and Gynecologists]] among other groups filed a lawsuit to relax the FDA's rule as to allow mifepristone to be acquired from mail-order and retail pharmacies. While the [[United States Court of Appeals for the Fourth Circuit|Fourth Circuit]] had granted a preliminary injunction to allow this distribution, the [[Supreme Court of the United States]] issued a stay order in January 2021 to retain the FDA's rule pending the results of the ongoing litigation.<ref>{{cite web | url = https://www.vox.com/22227912/supreme-court-anti-abortion-amy-coney-barrett-era-fda-american-college-sonia-sotomayor-john-roberts | title = The Supreme Court hands down its first anti-abortion decision of the Amy Coney Barrett era | vauthors = Millhauser I | date = 13 January 2021 | access-date = 13 January 2021 | work = [[Vox (website)|Vox]] | archive-date = 13 January 2021 | archive-url = https://web.archive.org/web/20210113003935/https://www.vox.com/22227912/supreme-court-anti-abortion-amy-coney-barrett-era-fda-american-college-sonia-sotomayor-john-roberts | url-status = live }}</ref>

On 16 December 2021, the FDA voluntarily adopted a new rule permanently relaxing the requirement that the pill be obtained in person, allowing it to be sent through the mail. A prescription is still required, so that a doctor can screen for risk factors that would make taking the pill unsafe for the mother.<ref>{{Cite web |url=https://www.npr.org/2021/12/16/1064951611/today-is-the-fda-s-deadline-to-complete-a-review-of-its-rules-for-abortion-pill |title=FDA relaxes restrictions on abortion pill |website=NPR.org |access-date=17 December 2021 |archive-date=17 December 2021 |archive-url=https://web.archive.org/web/20211217001550/https://www.npr.org/2021/12/16/1064951611/today-is-the-fda-s-deadline-to-complete-a-review-of-its-rules-for-abortion-pill |url-status=live }}</ref> In January 2023, the FDA further relaxed rules, allowing any retail pharmacy to become certified to fill mifepristone prescriptions.<ref name="mailed">{{Cite news |url=https://www.washingtonpost.com/national-security/2023/01/04/abortion-pills-mailed-legal/ |title=Justice Dept.: Postal Service may deliver abortion pills in any state |work=[[The Washington Post]] |url-access=subscription |access-date=5 January 2023 |archive-date=4 January 2023 |archive-url=https://web.archive.org/web/20230104235818/https://www.washingtonpost.com/national-security/2023/01/04/abortion-pills-mailed-legal/ |url-status=live }}</ref><ref name=WSJ_2023-01-03 >{{cite news | url=https://www.wsj.com/articles/abortion-pills-to-be-available-more-widely-under-new-fda-rules-11672789765 | title=Abortion Pills to Be Available More Widely Under New FDA Rules - Patients will be able to get the drug, called mifepristone, from bricks-and-mortar pharmacies | vauthors = Whyte LE | newspaper=[[The Wall Street Journal]] | date=3 January 2023 | access-date=7 January 2023 | archive-date=7 January 2023 | archive-url=https://web.archive.org/web/20230107011153/https://www.wsj.com/articles/abortion-pills-to-be-available-more-widely-under-new-fda-rules-11672789765 | url-status=live }}</ref>

After regulations on abortion early in pregnancy were ruled constitutional by the 2022 decision ''[[Dobbs v. Jackson Women's Health Organization]]'', some states enacted restrictions on abortions and abortion pills. In January 2023, the [[United States Department of Justice]] issued an interpretation of the [[Comstock Act]]<ref name="NYT-20240402">{{cite news | vauthors = Smith T |authorlink=Tina Smith |title=I Hope to Repeal an Arcane Law That Could Be Misused to Ban Abortion Nationwide |url=https://www.nytimes.com/2024/04/02/opinion/comstock-act-abortion-repeal.html |date=April 2, 2024 |work=[[The New York Times]] |url-status=live |archiveurl=https://archive.today/20240402124934/https://www.nytimes.com/2024/04/02/opinion/comstock-act-abortion-repeal.html |archivedate=April 2, 2024 |accessdate=April 2, 2024 }}</ref> that it was legal for [[United States Postal Service]] employees to deliver the pills in any state, because they could not know whether the pills would be used for an abortion or other purposes.<ref name="mailed" />

In January 2023, GenBioPro filed suit to overturn state laws that prohibit sale of mifepristone, claiming that such laws are invalid because it is a federally approved drug.<ref>{{cite web | vauthors = Belluck P | title=New Lawsuit Challenges State Bans on Abortion Pills | website=The New York Times | date=25 January 2023 | url=https://www.nytimes.com/2023/01/25/health/abortion-pills-ban-genbiopro.html | access-date=19 March 2023 | archive-date=25 January 2023 | archive-url=https://web.archive.org/web/20230125191039/https://www.nytimes.com/2023/01/25/health/abortion-pills-ban-genbiopro.html | url-status=live }}</ref>

The argument that state laws seeking to ban or restrict the use of mifepristone are preempted by the FDA's decision to make the drug available is supported by a number of Supreme Court decisions, including opinions by the traditionally more conservative Justices.<ref>{{cite journal | vauthors=Grossi P, O'Connor D | title=FDA preemption of conflicting state drug regulation and the looming battle over abortion medications | journal=The Journal of Law and the Biosciences | date=2023 | volume=10 | issue=1 | pages=lsad005 | doi=10.1093/jlb/lsad005 | pmid=36938304 | pmc=10017072 | url=https://doi.org/10.1093/jlb/lsad005}}</ref>

In March 2023, Wyoming became the first US state to ban the pill.<ref>{{cite news | vauthors=Horti S | title=Abortion pills banned in Wyoming as Texas judge considers nationwide decision | website=[[BBC News Online]] | date=18 March 2023 | url=https://www.bbc.com/news/world-us-canada-64998920 | access-date=1 April 2023 | archive-date=27 March 2023 | archive-url=https://web.archive.org/web/20230327173353/https://www.bbc.com/news/world-us-canada-64998920 | url-status=live }}</ref><ref>{{cite news | title=Wyoming Becomes First State to Outlaw the Use of Pills for Abortion | website=[[The New York Times]] | date=18 March 2023 | url=https://www.nytimes.com/2023/03/17/us/wyoming-abortion-pills-ban.html | access-date=2 April 2023 | archive-date=2 April 2023 | archive-url=https://web.archive.org/web/20230402023506/https://www.nytimes.com/2023/03/17/us/wyoming-abortion-pills-ban.html | url-status=live }}</ref>

In April 2023, in a lawsuit brought by 17 US states and the [[District of Columbia]], federal district judge [[Thomas O. Rice]] issued a temporary injunction that the FDA should not reduce access to mifepristone in these states and the district.<ref>{{cite news |title=Judge in Washington orders feds to keep abortion pill access |url=https://apnews.com/article/washington-abortion-pills-lawsuit-fda-1857d1a4fd356c61ad76e00621e93b44 |access-date=8 April 2023 |work=[[Associated Press]] |date=7 April 2023 |archive-date=8 April 2023 |archive-url=https://web.archive.org/web/20230408000944/https://apnews.com/article/washington-abortion-pills-lawsuit-fda-1857d1a4fd356c61ad76e00621e93b44 |url-status=live }}</ref><ref>{{cite news |vauthors=Ables K, Rosenzweig-Ziff D |title=Who is Thomas Rice, the Washington judge who ruled mifepristone is safe? |url=https://www.washingtonpost.com/politics/2023/04/08/washington-judge-abortion-thomas-rice/ |url-access=subscription |access-date=8 April 2023 |work=[[The Washington Post]] |date=8 April 2023 |archive-date=8 April 2023 |archive-url=https://web.archive.org/web/20230408083946/https://www.washingtonpost.com/politics/2023/04/08/washington-judge-abortion-thomas-rice/ |url-status=live }}</ref>

In May 2024, the state of Louisiana classified mifepristone and misoprostol as controlled substances, with penalties for possession without a prescription. The move follows concerns over coerced abortion and has drawn criticism from over 240 doctors in the state.<ref>{{Cite news | vauthors = Wax-Thibodeaux E |date=2024-05-13 |title=Louisiana moves to make abortion pills 'controlled dangerous substances' |url=https://www.washingtonpost.com/nation/2024/05/13/abortion-pills-louisiana-controlled-substance/ |url-access=subscription |access-date=2024-05-13 |work=[[The Washington Post]]}}</ref><ref>{{cite web | last=McGill | first=Kevin | title=Louisiana governor signs bill making two abortion drugs controlled dangerous substances | website=Associated Press | date=24 May 2024 | url=https://apnews.com/article/abortion-pills-louisiana-controlled-dangerous-substances-0984bfed536a5110997dd9c8264bf9e3 | access-date=5 September 2024}}</ref>

====FDA v. Alliance for Hippocratic Medicine====
{{main|FDA v. Alliance for Hippocratic Medicine}}
In April 2023, in the FDA v. Alliance for Hippocratic Medicine lawsuit, federal district judge [[Matthew J. Kacsmaryk]] issued a preliminary [[injunction]] suspending the 2000 approval of mifepristone, which would take effect a week later.<ref>{{cite news |archive-url=https://archive.today/20230408075712/https://www.nytimes.com/2023/04/07/health/abortion-pills-ruling-texas.html | vauthors = Belluck P |archive-date=8 April 2023| title=Texas Judge Invalidates FDA Approval of the Abortion Pill Mifepristone | work=The New York Times | date=7 April 2023 | url=https://www.nytimes.com/2023/04/07/health/abortion-pills-ruling-texas.html | access-date=7 April 2023}}</ref> The [[Fifth Circuit]] reversed parts of Kacsmaryk's injunction, but placed a temporary injunction on the 2016 REMS change to mifepristone. On appeal to the Supreme Court, the Court stayed both injunctions on 21 April 2023, with only Justices [[Samuel Alito]] and [[Clarence Thomas]] stating their dissent. The stay allowed mifepristone to remain legally available while the lower courts consider the merits of the case.

In June 2024, the US Supreme Court unanimously overturned judge [[Matthew Kacsmaryk|Kacsmaryk]]'s Fifth Circuit decision on the grounds that the Alliance for Hippocratic Medicine had no [[Standing (law)|standing]] to challenge the FDA's regulations of mifepristone.<ref>{{cite news|url=https://apnews.com/article/supreme-court-abortion-mifepristone-fda-4073b9a7b1cbb1c3641025290c22be2a|title=Unanimous Supreme Court preserves access to widely used abortion medication| vauthors = Sherman M |publisher=Associated Press|date=June 13, 2024|accessdate=June 13, 2024}}</ref><ref>{{cite news|url=https://www.nbcnews.com/politics/supreme-court/supreme-court-rejects-bid-restrict-access-abortion-pill-rcna151308|title=Supreme Court rejects bid to restrict access to abortion pill| vauthors = Hurley L |publisher=NBC News|date=June 13, 2024|access-date=June 13, 2024}}</ref> The Supreme Court ruled that Alliance for Hippocratic Medicine did not demonstrate that they would suffer harm to warrant standing. The Court did not rule on the substance of mifepristone, abortion, or the FDA's procedures.<ref>{{cite court |litigants= Food and Drug Administration et al. v. Alliance for Hippocratic Medicine et al. |vol= 602|reporter= U.S. |opinion= 23-235 |pinpoint= |court= United States Supreme Court|date= 13 June 2004 |url= https://www.supremecourt.gov/opinions/23pdf/23-235_n7ip.pdf |quote= |postscript= }}</ref>

====Subsection H====
Some drugs are approved by the FDA under subsection H, which has two subparts. The first sets forth ways to rush experimental drugs, such as aggressive HIV and cancer treatments, to market when speedy approval is deemed vital to the health of potential patients. The second part of subsection H applies to drugs that not only must meet restrictions for use due to safety requirements, but also are required to meet [[postmarketing surveillance]] to establish that the safety results shown in clinical trials are seconded by use in a much wider population. Until December 2021, Mifepristone was approved under the second part of subsection H. The result is that women could not pick the drug up at a [[pharmacy]], but were required to receive it directly from a doctor. Due to the possibility of adverse reactions such as excessive bleeding, which may require a [[blood transfusion]], and incomplete abortion, which may require surgical intervention, the drug was only considered safe if a physician who is capable of administering a blood transfusion or a surgical abortion is available to the patient in the event of such emergencies.<ref>{{cite web | vauthors = Woodcock J | title = Testimony on RU-486 | work = Committee on Government Reform, House of Representatives | publisher = FDA | date = 12 May 2006 | url = https://www.fda.gov/ola/2006/mifepristone0517.html | access-date = 19 August 2006 |archive-url = https://web.archive.org/web/20060927090806/https://www.fda.gov/ola/2006/mifepristone0517.html <!-- Bot retrieved archive --> |archive-date = 27 September 2006}}</ref> The approval of mifepristone under subsection H included a [[black box warning]].

====European Union====
Outside the United States, mifepristone is marketed and distributed by Exelgyn Laboratories under the brand name Mifegyne. It was approved for use in [[Abortion in France|France]] in 1988 (initial marketing in 1989), the [[Abortion in the United Kingdom|United Kingdom]] in 1991, [[Abortion in Sweden|Sweden]] in 1992, then [[Abortion in Austria|Austria]], [[Abortion in Belgium|Belgium]], [[Abortion in Denmark|Denmark]], [[Abortion in Finland|Finland]], [[Abortion in Germany|Germany]], [[Abortion in Greece|Greece]], [[Abortion in Luxembourg|Luxembourg]], [[Abortion in the Netherlands|the Netherlands]], [[Abortion in Spain|Spain]], and [[Abortion in Switzerland|Switzerland]] in 1999.<ref>{{cite journal | vauthors = Christin-Maitre S, Bouchard P, Spitz IM | title = Medical termination of pregnancy | journal = The New England Journal of Medicine | volume = 342 | issue = 13 | pages = 946–56 | date = March 2000 | pmid = 10738054 | doi = 10.1056/NEJM200003303421307 }}</ref> In 2000, it was approved in Norway, Russia and Ukraine. Serbia and Montenegro approved it in 2001,<ref>{{cite journal | vauthors = Stojnić J, Ljubić A, Jeremić K, Radunović N, Tulić I, Bosković V, Dukanac J | title = [Medicamentous abortion with mifepristone and misoprostol in Serbia and Montenegro] | journal = Vojnosanitetski Pregled | volume = 63 | issue = 6 | pages = 558–63 | date = June 2006 | pmid = 16796021 | doi = 10.2298/VSP0606558S | doi-access = free | title-link = doi }}</ref> [[Abortion in Belarus|Belarus]] and [[Abortion in Latvia|Latvia]] in 2002, [[Abortion in Estonia|Estonia]] in 2003, [[Abortion in Moldova|Moldova]] in 2004, [[Abortion in Albania|Albania]] and [[Abortion in Hungary|Hungary]] in 2005, [[Abortion in Portugal|Portugal]] in 2007, [[Abortion in Romania|Romania]] in 2008,<ref name="Gynuity 2009"/> [[Abortion in Bulgaria|Bulgaria]], [[Abortion in the Czech Republic|Czech Republic]] and [[Abortion in Slovenia|Slovenia]] in 2013.<ref>{{Cite web |url=http://gynuity.org/resources/read/llist-of-mifepristone-approval-en/ |title=List of Mifepristone Approvals | work = Gynuity Health Projects | date = March 2017 |access-date=28 September 2017 |archive-url= https://web.archive.org/web/20170926164348/http://gynuity.org/resources/read/llist-of-mifepristone-approval-en |archive-date=26 September 2017 |url-status=dead }}</ref> In [[Abortion in Italy|Italy]], clinical trials have been constrained by protocols requiring women be hospitalized for three days, but the drug was finally approved on 30 July 2009 (officialized later in the year), despite strong opposition from the Vatican. In Italy, the pill must be prescribed and used in a clinical structure and is not sold at chemists.<ref>{{cite news |date=31 July 2009 |title=Abortion pill approved in Italy |url=http://news.bbc.co.uk/1/hi/world/europe/8178152.stm |work=BBC News |access-date=31 July 2009 |archive-date=8 September 2017 |archive-url=https://web.archive.org/web/20170908184336/http://news.bbc.co.uk/1/hi/world/europe/8178152.stm |url-status=live }}</ref> It was approved in Hungary in 2005, but as of 2005 had not been released on the market yet, and was the target of protests.<ref>{{cite news|title=Abortion pill sparks bitter protest|newspaper=The Budapest Times|date=19 September 2005|access-date=16 September 2006|url=http://www.budapesttimes.hu/index.php?art=1077|url-status=live|archive-url=https://web.archive.org/web/20070111100214/http://www.budapesttimes.hu/index.php?art=1077|archive-date=11 January 2007}}</ref> Mifepristone is licensed in [[Abortion in the Republic of Ireland|Ireland]] for use of abortions up to 12 weeks since it was legalised in 2018.<ref>{{Cite web |url=https://www.hse.ie/eng/staff/pcrs/circulars/pharmacy/pharmacy-circular-040-2018.pdf | vauthors = Hoey AM |title= Medicines for Termination of Pregnancy Services | work = Health Service Executive. Primary Care Reimbursement Service | location = Dublin, Ireland | date = 20 December 2018 |access-date=28 June 2022 |archive-date=2 April 2022 |archive-url= https://web.archive.org/web/20220402045614/https://www.hse.ie/eng/staff/pcrs/circulars/pharmacy/pharmacy-circular-040-2018.pdf |url-status=live }}</ref> Mifepristone is not available in [[Abortion in Poland|Poland]], where abortion is highly restricted.<ref>{{cite news| vauthors = Green PS |title=A Rocky Landfall for a Dutch Abortion Boat|newspaper=The New York Times|date=24 June 2003|access-date=16 September 2006|url=https://query.nytimes.com/gst/fullpage.html?sec=health&res=9F02E3D7153BF937A15755C0A9659C8B63|url-status=live|archive-url=https://web.archive.org/web/20070210071338/http://query.nytimes.com/gst/fullpage.html?sec=health|archive-date=10 February 2007}}</ref>

Mifepristone 200&nbsp;mg tablets (Mifegyne, Mifepristone Linepharma, Medabon) have marketing authorizations in the [[European Economic Area]] from the [[European Medicines Agency]] (EMA) for:<ref name="Mifegyne SPC 2015"/><ref name="Mifepristone Linepharma SPC 2014">{{cite web|author=Linepharma|date=7 November 2014|title=Mifepristone Linepharma Summary of Product Characteristics (SPC)|location=London|publisher=Medicines and Healthcare Products Regulatory Agency (MHRA)|url=http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1452842392219.pdf|access-date=14 April 2016|url-status=dead|archive-url=https://web.archive.org/web/20160602234626/http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1452842392219.pdf|archive-date=2 June 2016}}</ref><ref name="Medabon SPC 2015">{{cite web|author=Sun Pharmaceuticals|date=4 March 2015|title=Medabon Summary of Product Characteristics (SPC)|location=London|publisher=Medicines and Healthcare Products Regulatory Agency (MHRA)|url=http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1454653236118.pdf|access-date=4 April 2016|url-status=dead|archive-url=https://web.archive.org/web/20160603014327/http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1454653236118.pdf|archive-date=3 June 2016}}</ref>
* Early first trimester medication abortion when followed by a prostaglandin analog (misoprostol or gemeprost) through 63 days gestational age
* Second trimester medication abortion when followed by a prostaglandin analog
* [[Cervical dilation|Cervical softening and dilation]] prior to first trimester [[abortion#Surgical|surgical abortion]]
* [[Labor induction|Induction of labor]] after fetal death in utero when prostaglandin analogs and [[oxytocin]] are contraindicated

====Other countries====
Mifepristone was banned in Australia in 1996. In 2005, a private member's bill was introduced to the Australian Senate to lift the ban and transfer the power of approval to the [[Therapeutic Goods Administration]] (TGA). The move caused much debate in the Australian media and among politicians. The bill passed the Senate in February 2006, and mifepristone is legal in Australia. It is provided regularly at several specialized abortion clinics per state.<ref>{{cite web|title=Marie Stopes International Australia – Medical Abortion |year=2010 |access-date=15 December 2010 |url=http://www.mariestopes.org.au/our-services/women/abortion/medical-abortion |url-status=dead |archive-url=https://web.archive.org/web/20101122164158/http://www.mariestopes.org.au/our-services/women/abortion/medical-abortion |archive-date=22 November 2010 }}</ref><ref>{{cite web|title=Abortion pill – RU486 (mifepristone) |publisher=Better Health Channel Victoria |date=July 2010 |access-date=15 December 2010 |url=http://www.betterhealth.vic.gov.au/bhcv2/bhcarticles.nsf/pages/abortion_pill_ru486_%28mifepristone%29?open |url-status=dead |archive-url=https://web.archive.org/web/20100814183721/http://www.betterhealth.vic.gov.au/bhcv2/bhcarticles.nsf/pages/Abortion_pill_RU486_%28mifepristone%29?open |archive-date=14 August 2010 }}</ref> Mifepristone 200&nbsp;mg tablets have marketing authorizations in Australia from the TGA for early first trimester medication abortion when followed by the prostaglandin analog misoprostol through 63 days gestational age<ref name="Mifepristone Linepharma (MS-2 Step) PI 2014">{{cite web|author=MS Health|date=24 December 2014|title=Mifepristone Linepharma (MS-2 Step) 200 mg tablet product information|location=Symonston, Australian Capital Territory, Australia|publisher=Therapeutic Goods Administration|url=https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2014-PI-01965-1|access-date=4 April 2016|url-status=live|archive-url=https://web.archive.org/web/20170908184336/https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2014-PI-01965-1|archive-date=8 September 2017}}</ref> and second trimester medication abortion when followed by a prostaglandin analog.<ref name="Mifepristone Linepharma PI 2015">{{cite web|author=MS Health|date=12 May 2015|title=Mifepristone Linepharma 200 mg tablet product information|location=Symonston, Australian Capital Territory, Australia|publisher=Therapeutic Goods Administration|url=https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2012-PI-02513-1|access-date=4 April 2016|archive-date=9 September 2017|archive-url=https://web.archive.org/web/20170909005923/https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2012-PI-02513-1|url-status=live}}</ref><ref>{{cite web | title=Mifepristone (Mifepristone Linepharma) followed by misoprostol (GyMiso) for terminating early pregnancy | website=NPS MedicineWise | date=16 February 2015 | url=https://www.nps.org.au/news/mifepristone-mifepristone-linepharma-followed-by-misoprostol-gy-miso-for-terminating-early-pregnancy | access-date=5 September 2024}}</ref>

In New Zealand, pro-abortion rights doctors established an import company, Istar, and submitted a request for approval to [[Medsafe]], the New Zealand pharmaceutical regulatory agency. After a court case brought by Right to Life New Zealand failed, use of mifepristone was permitted.<ref>{{cite journal | vauthors = Sparrow MJ | title = A woman's choice | journal = The Australian & New Zealand Journal of Obstetrics & Gynaecology | volume = 44 | issue = 2 | pages = 88–92 | date = April 2004 | pmid = 15089829 | doi = 10.1111/j.1479-828X.2004.00190.x | s2cid = 27365359 }}</ref>

Mifepristone was approved in Israel in 1999.<ref>{{cite journal | vauthors = Baulieu EE, Seidman DS, Hajri S | title = Mifepristone (RU486) and voluntary termination of pregnancy: enigmatic variations or anecdotal religion-based attitudes? | journal = Human Reproduction | volume = 16 | issue = 10 | pages = 2243–4 | date = October 2001 | pmid = 11574524 | doi = 10.1093/humrep/16.10.2243 | doi-access = free | title-link = doi }}</ref>

Clinical trials of mifepristone in China began in 1985. In October 1988, China became the first country in the world to approve mifepristone. Chinese organizations tried to purchase mifepristone from [[Roussel Uclaf]], which refused to sell it to them, so in 1992 China began its own domestic production of mifepristone. In 2000, the cost of medication abortion with mifepristone was higher than surgical abortion and the percentage of medication abortions varied greatly, ranging from 30% to 70% in cities to being almost nonexistent in rural areas.<!--
 --><ref name="ulmann">{{cite journal | vauthors = Ulmann A |year=2000 |title=The development of mifepristone: a pharmaceutical drama in three acts |journal=J Am Med Women's Assoc |volume=55 |issue=3 Suppl |pages=117–20 |pmid=10846319}}</ref><!--
 --><ref name="wu">{{cite journal | vauthors = Wu S |year=2000 |title=Medical abortion in China |journal=J Am Med Women's Assoc |volume=55 |issue=3 Suppl |pages=197–9, 204 |pmid=10846339}}</ref>
A report from the [[United States Embassy]] in Beijing in 2000 said mifepristone had been widely used in Chinese cities for about two years, and that according to press reports, a [[black market]] had developed with many women starting to buy it illegally (without a prescription) from private clinics and drugstores for about {{USD|15|2000}}, causing Chinese authorities to worry about medical complications from use without physician supervision.<ref>{{cite web|title=Family planning in China: RU-486, abortion, and population trends |publisher=U.S. Embassy Beijing |year=2000 |access-date=14 September 2006 |url=http://www.usembassy-china.org.cn/sandt/ru486.html |archive-url=https://web.archive.org/web/20020311164554/http://www.usembassy-china.org.cn/sandt/ru486.html |url-status=dead |archive-date=11 March 2002 }}</ref>

In 2001, mifepristone was approved in Taiwan.<ref>{{cite journal|vauthors=Tsai EM, Yang CH, Lee JN |title=Medical abortion with mifepristone and misoprostol: a clinical trial in Taiwanese women|journal=J Formos Med Assoc|year=2002|volume=101|issue=4|pmid=12101864|pages=277–82}}</ref> Vietnam included mifepristone in the National Reproductive Health program in 2002.<ref>{{cite journal|vauthors=Ganatra B, Bygdeman M, Nguyen DV, Vu ML, Phan BT |title=From research to reality: the challenges of introducing medical abortion into service delivery in Vietnam|journal=Reprod Health Matters|year=2004|volume=12|issue=24|pages=105–13|pmid=15938163|doi=10.1016/S0968-8080(04)24022-8|s2cid=23303852}}</ref>

Mifepristone is approved in only one sub-Saharan African country—South Africa, where it was approved in 2001.<ref>{{cite web|title=Medical Abortion-Implications for Africa|publisher=[[Ipas (non-profit)|Ipas]]|year=2003|access-date=16 September 2006|url=http://www.ipas.org/publications/en/Medical_Abortion/med_ab_africa_web_only_en.pdf.|url-status=dead|archive-url=https://web.archive.org/web/20070928082424/http://www.ipas.org/publications/en/Medical_Abortion/med_ab_africa_web_only_en.pdf.|archive-date=28 September 2007}}</ref> It is also approved in one north African country—Tunisia, also in 2001.<ref>{{cite journal| vauthors = Hajri S|title=Medication abortion: the Tunisian experience|journal=Afr J Reprod Health|year=2004|volume=8|issue=1|pmid=15487615|pages=63–9|doi=10.2307/3583307|jstor=3583307|hdl=1807/3883|hdl-access=free}}</ref>

Mifepristone was approved for use in India in 2002, where medication abortion is referred to as "medical termination of pregnancy". It is only available under medical supervision, not by prescription, due to adverse reactions such as excessive bleeding, and criminal penalties are given for buying or selling it on the black market or over-the-counter at pharmacies.<ref>{{cite web|title=Mifepristone can be sold only to approved MTP Centres: Rajasthan State HRC|publisher=Indian Express Health Care Management|year=2000|url=http://www.expresshealthcaremgmt.com/20040515/oped01.shtml|url-status=usurped|archive-url=https://web.archive.org/web/20120124021131/http://www.expresshealthcaremgmt.com/20040515/oped01.shtml|archive-date=24 January 2012}}</ref>

Medication induced abortion used to be available in Canada but on a limited basis using methotrexate and misoprostol. Clinical trials were done in 2000 in various Canadian cities comparing methotrexate to mifepristone, after approbation by the federal government. While both drugs had overall similar results, mifepristone was found to act faster.<ref>{{cite web | url = http://www.cbctrust.com/ru486_trials_canada.php | archive-url = https://web.archive.org/web/20060621162826/http://www.cbctrust.com/ru486_trials_canada.php | archive-date = 21 June 2006 | title = Results of the Canadian trials of RU486, the 'Abortion Pill | access-date = 8 December 2006 }}</ref> Health Canada gave approval to mifepristone in July 2015.<ref>{{Cite web|title = RU-486 abortion pill approved by Health Canada|url = http://www.cbc.ca/news/health/ru-486-abortion-pill-approved-by-health-canada-1.3173515?cmp=rss|access-date = 30 July 2015|url-status = live |archive-url = https://web.archive.org/web/20150731021931/http://www.cbc.ca/news/health/ru-486-abortion-pill-approved-by-health-canada-1.3173515?cmp=rss |archive-date = 31 July 2015 }}</ref> Initially, its use was limited to seven weeks into a pregnancy, but this was changed to nine weeks in 2017. The previous requirement of written consent from the woman was also ended at the same time. It can be dispensed directly to a patient by a pharmacist or a prescribing health professional. Women are required to have an ultrasound to ensure the pregnancy is not [[ectopic pregnancy|ectopic]].<ref>{{cite news |title=Health Canada eases restrictions on abortion pill Mifegymiso |work=CBC News |url=http://www.cbc.ca/news/health/mifegymiso-abortion-pill-health-canada-1.4391267 |access-date=28 April 2018 |archive-date=8 May 2018 |archive-url=https://web.archive.org/web/20180508043809/http://www.cbc.ca/news/health/mifegymiso-abortion-pill-health-canada-1.4391267 |url-status=live }}</ref>

Mifepristone was registered for use in Azerbaijan, Georgia, and Uzbekistan in 2002, in Guyana and Moldova in 2004, in Mongolia in 2005, and in Armenia in 2007.<ref name="Gynuity 2009"/><ref>{{cite web|title=Medication Abortion|publisher=Ibis|year=2002|access-date=19 September 2006|url=http://www.medicationabortion.com/mifepristone/index.html|url-status=live|archive-url=https://web.archive.org/web/20061104040928/http://www.medicationabortion.com/mifepristone/index.html|archive-date=4 November 2006}}</ref>

Low dose mifepristone tablets for emergency contraception are available directly from a pharmacist without a prescription and with a prescription in China.<ref name="Trussell 2013">{{cite web |date=13 February 2013 |title=Dedicated emergency contraceptive pills worldwide |url=http://ec.princeton.edu/pills/Dedicated_ECPs.pdf |url-status=dead |archive-url=https://web.archive.org/web/20160304190311/http://ec.princeton.edu/pills/Dedicated_ECPs.pdf |archive-date=4 March 2016 |access-date=4 April 2016 |publisher=Office of Population Research, Princeton University |vauthors=Trussell J, Cleland K |location=Princeton}}</ref><ref name="ICEC 2013">{{cite web |author= |year=2016 |title=EC pill types and countries of availability, by brand |url=http://www.cecinfo.org/country-by-country-information/status-availability-database/ec-pill-types-and-countries-of-availability-by-brand/ |url-status=usurped |archive-url=https://web.archive.org/web/20160405095026/http://www.cecinfo.org/country-by-country-information/status-availability-database/ec-pill-types-and-countries-of-availability-by-brand/ |archive-date=5 April 2016 |access-date=4 April 2016 |publisher=International Consortium for Emergency Contraception |location=New York}}</ref><ref name="Trussell 2016">{{cite web |date=March 2016 |title=Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy |url=http://ec.princeton.edu/questions/ec-review.pdf |url-status=live |archive-url=https://web.archive.org/web/20100923040101/http://ec.princeton.edu/questions/ec-review.pdf |archive-date=23 September 2010 |access-date=7 April 2016 |publisher=Office of Population Research, Princeton University |vauthors=Trussell J, Raymond E |location=Princeton}}</ref>

Low dose mifepristone tablets for emergency contraception are available by prescription in Armenia (Gynepriston), Russia (Agesta, Gynepriston, Mifepristone 72, Negele), Ukraine (Gynepriston), and Vietnam (Mifestad 10, Ciel EC).<ref name="Trussell 2013"/><ref name="ICEC 2013"/><ref name="Trussell 2016"/>