Editing Mifepristone (section)

==History==
===1980–1987===
In April 1980, as part of a formal research project at the French pharmaceutical company [[Roussel-Uclaf]] for the development of glucocorticoid receptor antagonists, endocrinologist [[Étienne-Émile Baulieu]]<ref>{{Cite book|url=https://books.google.com/books?id=pC1pZDcibsUC&q=%C3%89tienne-%C3%89mile+Baulieu+mifepristone|title=The "abortion Pill": RU-486, a Woman's Choice|isbn=978-0-671-73816-7|vauthors=Baulieu EE, Rosenblum M|year=1991|publisher=Simon & Schuster |access-date=20 February 2022|archive-date=29 June 2022|archive-url=https://web.archive.org/web/20220629032703/https://books.google.com/books?id=pC1pZDcibsUC&q=%C3%89tienne-%C3%89mile+Baulieu+mifepristone|url-status=live}}</ref><ref>{{Cite book|url = https://books.google.com/books?id=RuJwDwAAQBAJ&dq=%C3%89tienne-%C3%89mile+Baulieu+mifepristone&pg=PA148|title = Reproductive Medicine for Clinical Practice: Medical and Surgical Aspects|isbn = 978-3-319-78009-2|vauthors = Schenker JG, Sciarra JJ, Mettler L, Genazzani AR, Birkhaeuser M|date = 29 September 2018| publisher=Springer |access-date = 4 March 2022|archive-date = 29 June 2022|archive-url = https://web.archive.org/web/20220629032703/https://books.google.com/books?id=RuJwDwAAQBAJ&dq=%C3%89tienne-%C3%89mile+Baulieu+mifepristone&pg=PA148|url-status = live}}</ref> and chemist Georges Teutsch synthesized mifepristone (RU-38486, the 38,486th compound synthesized by Roussel-Uclaf from 1949 to 1980; shortened to RU-486), which was discovered to also be a progesterone receptor antagonist.<ref name="RU-486">{{cite book | vauthors = Baulieu ÉÉ, Rosenblum M |year=1991 |title=The "abortion pill": RU-486, a woman's choice |location=New York |publisher=Simon & Schuster |isbn=978-0-671-73816-7 |url=https://archive.org/details/abortionpillru00baul }}<br />{{cite book | vauthors = Lader L |year=1991 |title=RU 486: the pill that could end the abortion wars and why American women don't have it |location=Reading |publisher=Addison-Wesley |isbn=978-0-201-57069-4 |url=https://archive.org/details/ru486pillthatcou00lade }}<br />{{cite book| vauthors = Villaran G |chapter=RU 486 |pages=155–190 | veditors = Schlegelmilch, Bodo B |year=1998 |title=Marketing ethics: an international perspective |location=London |publisher=Thomson Learning |isbn=978-1-86152-191-0}}<br />{{cite journal | vauthors = Ulmann A | title = The development of mifepristone: a pharmaceutical drama in three acts | journal = Journal of the American Medical Women's Association | volume = 55 | issue = 3 Suppl | pages = 117–20 | year = 2000 | pmid = 10846319 }}</ref><ref>{{cite journal | vauthors = Teutsch G | title = RU 486 development | journal = Science | volume = 246 | issue = 4933 | pages = 985 | date = November 1989 | pmid = 2587990 | doi = 10.1126/science.2587990 | s2cid = 41144964 }}<br />{{cite journal | vauthors = Cherfas J | title = Dispute surfaces over paternity of RU 486 | journal = Science | volume = 246 | issue = 4933 | pages = 994 | date = November 1989 | pmid = 2587988 | doi = 10.1126/science.2587988 | bibcode = 1989Sci...246..994C }}<br />{{cite journal | vauthors = Philibert D, Teutsch G | title = RU 486 development | journal = Science | volume = 247 | issue = 4943 | pages = 622 | date = February 1990 | pmid = 2300819 | doi = 10.1126/science.2300819 | bibcode = 1990Sci...247..622P }}<br />{{cite magazine|doi=10.1038/scientificamerican0690-42 | vauthors = Ulmann A, Teutsch G, Philibert D |date=June 1990 |title=RU 486 |magazine=Scientific American|volume=262 |issue=6 |pages=42–8 |pmid=2343294}}<br />{{cite book | vauthors = Teutsch G, Deraedt R, Philibert D |year=1993 |chapter=Mifepristone |pages=[https://archive.org/details/chroniclesofdrug0000unse/page/1 1–43] | veditors = Lednicer D |title=Chronicles of drug discovery, Vol. 3 |location=Washington, DC |publisher=American Chemical Society |isbn=978-0-8412-2523-7 |chapter-url=https://archive.org/details/chroniclesofdrug0000unse/page/1 }}<br />{{cite journal | vauthors = Teutsch G, Philibert D | title = History and perspectives of antiprogestins from the chemist's point of view | journal = Human Reproduction | volume = 9 | issue = Suppl 1 | pages = 12–31 | date = June 1994 | pmid = 7962457 | doi = 10.1093/humrep/9.suppl_1.12 }}<br />{{cite book |year=2007 |chapter=Mifepristone |pages=2307–2310 | veditors = Sittig M |title=Pharmaceutical manufacturing encyclopedia |edition=3rd |location=Norwich, NY |publisher=William Andrew Publishing |isbn=978-1-60119-339-1}}<br />{{cite patent|country = US | number=4386085 |gdate = 31 May 1983 |inventor = Teutsch JG, Costerousse G, Philibert D Deraedt R |title=Novel steroids | assign1 = Roussel Uclaf | postscript = . }}</ref> In October 1981, Étienne-Émile Baulieu, a consultant to Roussel-Uclaf, arranged tests of its use for medical abortion in 11 women in [[Switzerland]] by gynecologist Walter Herrmann at the [[University of Geneva]]'s Cantonal Hospital, with successful results announced on 19 April 1982.<ref name="RU-486" /><ref>{{cite news | vauthors = Eder R |date=20 April 1982 |title=Birth control: 4-day pill is promising in early test |newspaper=The New York Times |page=C1 |url=https://www.nytimes.com/1982/04/20/science/birth-control-4-day-pill-is-promising-in-early-test.html?&pagewanted=all |url-status=live |archive-url=https://web.archive.org/web/20160625131822/http://www.nytimes.com/1982/04/20/science/birth-control-4-day-pill-is-promising-in-early-test.html?&pagewanted=all |archive-date=25 June 2016 }}<br />{{cite journal | vauthors = Herrmann W, Wyss R, Riondel A, Philibert D, Teutsch G, Sakiz E, Baulieu EE | title = [The effects of an antiprogesterone steroid in women: interruption of the menstrual cycle and of early pregnancy] | journal = Comptes Rendus de l'Académie des Sciences, Série III | volume = 294 | issue = 18 | pages = 933–8 | date = May 1982 | pmid = 6814714 }}</ref> On 9 October 1987, following worldwide clinical trials in 20,000 women of mifepristone with a [[prostaglandin]] analogue (initially [[sulprostone]] or [[gemeprost]], later [[misoprostol]]) for medical abortion, Roussel-Uclaf sought approval in France for their use for medical abortion, with approval announced on 23 September 1988.<ref name="RU-486" /><ref>{{cite news | vauthors = Kolata G |date=24 September 1988 |title=France and China allow sale of a drug for early abortion |newspaper=The New York Times |page=A1 |url=https://www.nytimes.com/1988/09/24/us/france-and-china-allow-sale-of-a-drug-for-early-abortion.html |url-access=subscription |url-status=live |archive-url=https://web.archive.org/web/20170901111410/http://www.nytimes.com/1988/09/24/us/france-and-china-allow-sale-of-a-drug-for-early-abortion.html |archive-date=1 September 2017 }}</ref>

===1988–1990===
On 21 October 1988, in response to antiabortion protests and concerns of majority (54.5%) owner Hoechst AG of Germany, Roussel-Uclaf's executives and board of directors voted 16 to 4 to stop distribution of mifepristone, which they announced on 26 October 1988.<ref name="RU-486" /><ref>{{cite news |newspaper=[[The New York Times]] |page=A1 | vauthors = Greenhouse S |date=27 October 1988 |title=Drug maker stops all distribution of abortion pill |url=https://www.nytimes.com/1988/10/27/us/drug-maker-stops-all-distribution-of-abortion-pill.html |url-status=live |archive-url= https://web.archive.org/web/20160305014315/http://www.nytimes.com/1988/10/27/us/drug-maker-stops-all-distribution-of-abortion-pill.html |archive-date=5 March 2016 }}</ref> Two days later, the French government ordered Roussel-Uclaf to distribute mifepristone in the interests of public health.<ref name="RU-486" /><ref>{{cite news | vauthors = Greenhouse S |date=29 October 1988 |title=France ordering company to sell its abortion drug |newspaper=The New York Times |page=A1 |url=https://www.nytimes.com/1988/10/29/world/france-ordering-company-to-sell-its-abortion-drug.html |url-status=live |archive-url=https://web.archive.org/web/20160304235250/http://www.nytimes.com/1988/10/29/world/france-ordering-company-to-sell-its-abortion-drug.html |archive-date=4 March 2016 }}</ref> French Health Minister [[Claude Évin]] explained: "I could not permit the abortion debate to deprive women of a product that represents medical progress. From the moment Government approval for the drug was granted, RU-486 became the moral property of women, not just the property of a drug company."<ref name="RU-486" /> Following use by 34,000 women in France from April 1988 to February 1990 of mifepristone distributed free of charge, Roussel-Uclaf began selling Mifegyne (mifepristone) to hospitals in France in February 1990 at a price (negotiated with the French government) of {{USD|48|1990}} per 600-mg dose.<ref name="RU-486" />

===1991–1996===
Mifegyne was subsequently approved in Great Britain in July 1991,<ref>{{cite journal | vauthors = Smith W |date=September 1991 |title=Great Britain second country to allow use of RU-486 |journal=Plan Parent Eur |volume=20|issue=2 |page=20 |pmid=12284548}}</ref> and in [[Sweden]] in September 1992,<ref>{{cite journal |date=December 1992 |title=RU 486 licensed in Sweden |journal=IPPF Med Bull |volume=26 |issue=6 |page=6 |pmid=12346922}}</ref> but until his retirement in April 1994, Hoechst AG chairman Wolfgang Hilger, a devout [[Catholic Church|Roman Catholic]],<ref name=RU486HoechtIGFarben.NYP>{{cite news |work=[[New York Post]] |title=Nazi link may keep RU-486 out | vauthors = Peyser A |date=2 July 1992 |pages=5, 18}}</ref> blocked any further expansion in availability.<ref name="RU-486" /><ref name=1993unitedstateseffort>{{cite news | vauthors = Newman B |date=22 February 1993 |title=Drug dilemma: among those wary of abortion pill is maker's parent firm; Germany's Hoechst is facing pressure from Clinton to sell RU-486 in U.S. |newspaper=The Wall Street Journal |page=A1}}<br />{{cite news |agency=Associated Press |date=16 April 1993 |title=F.D.A. says company delays abortion pill |newspaper=The New York Times |page=A14 |url=https://www.nytimes.com/1993/04/16/us/fda-says-company-delays-abortion-pill.html |url-status=live |archive-url=https://web.archive.org/web/20160803201914/http://www.nytimes.com/1993/04/16/us/fda-says-company-delays-abortion-pill.html |archive-date=3 August 2016 }}<br />{{cite news | vauthors = Jouzaitis C |date=17 October 1994 |title=Abortion pill battle surprises French firm |newspaper=Chicago Tribune |page=1 (Business) |url=https://pqasb.pqarchiver.com/chicagotribune/access/24140469.html?dids=24140469:24140469&FMT=ABS&FMTS=ABS:FT |url-status=dead |archive-url=https://web.archive.org/web/20130218193337/http://pqasb.pqarchiver.com/chicagotribune/access/24140469.html?dids=24140469%3A24140469&FMT=ABS&FMTS=ABS%3AFT |archive-date=18 February 2013 }}</ref> Soon after becoming U.S. President in 1993, [[Bill Clinton]] ordered the U.S. Health and Human Services Department to investigate mifepristone's potential as an abortion medication, and also pressured Hoeschst to make the RU-486 medication available in the United States.<ref name=1993unitedstateseffort /><ref>{{cite news|url=https://www.reproductiveaccess.org/2023/04/history-of-mifepristone/|title=The History of Mifepristone|publisher=Reproductive Health Access Project|date=April 18, 2023|accessdate=June 13, 2024}}</ref><ref>{{cite news|url=https://www.latimes.com/archives/la-xpm-2000-nov-05-mn-47330-story.html|title=Persistence Brought Abortion Pill to U.S.| vauthors = Bernstein S |publisher=Los Angeles|date=November 5, 2000|accessdate=June 13, 2024}}</ref> On 16 May 1994, Roussel-Uclaf announced it was donating without remuneration all rights for medical uses of mifepristone in the United States to the [[Population Council]],<ref name="Seelye 1994">{{cite news | vauthors = Seelye KQ |date=17 May 1994 |title=Accord opens way for abortion pill in U.S. in 2 years |newspaper=The New York Times |page=A1 |url=https://www.nytimes.com/1994/05/17/us/accord-opens-way-for-abortion-pill-in-us-in-2-years.html?&pagewanted=all |url-status=live |archive-url=https://web.archive.org/web/20160803200331/http://www.nytimes.com/1994/05/17/us/accord-opens-way-for-abortion-pill-in-us-in-2-years.html?&pagewanted=all |archive-date=3 August 2016 }}</ref> which would then sponsor clinical trials for mifepristone between September 1994 and September 1995.<ref name=1990suslaunch>{{cite journal | vauthors = Simonds W, Ellertson C, Springer K, Winikoff B | title = Abortion, revised: participants in the U.S. clinical trials evaluate mifepristone | journal = Social Science & Medicine | volume = 46 | issue = 10 | pages = 1313–1323 | date = May 1998 | pmid = 9665563 | doi = 10.1016/S0277-9536(97)10063-6 }}</ref> In September 1995, The Population Council licensed mifpristone to [[Danco Laboratories]], which was a new, single-product company that was intended to be resistant to antiabortion boycotts.<ref name=dancomifpristone /><ref name=dancoandfdaapproval>{{cite news | vauthors = Kolata G |date=29 September 2000 |title=U.S. approves abortion pill; drug offers more privacy and could reshape debate |newspaper=The New York Times |page=A1 |url=https://www.nytimes.com/2000/09/29/us/us-approves-abortion-pill-drug-offers-more-privacy-and-could-reshape-debate.html |url-status=live |archive-url=https://web.archive.org/web/20170804114939/http://www.nytimes.com/2000/09/29/us/us-approves-abortion-pill-drug-offers-more-privacy-and-could-reshape-debate.html |archive-date=4 August 2017 }}</ref>  Danco entered into a manufacturing agreement with Hungarian drug manufacturer [[Gedeon Richter (company)|Gedeon Richter]].<ref name=dancomifpristone>{{cite web|url=https://caselaw.findlaw.com/court/ny-supreme-court-appellate-division/1151610.html |title=DANCO LABORATORIES LIMITED v. The Washington Post Company, Intervenor-Appellant. (2000)|publisher=Supreme Court, Appellate Division, First Department, New York. |date=July 27, 2000 |accessdate=June 13, 2024 |via=caselaw.findlaw.com}}</ref> In 1996, the US [[Food and Drug Administration]] (FDA) conditionally licensed RU-486 for early trimester abortion, pending a resolution on some remaining technical and manufacturing issues.<ref name=1990suslaunch />

===1997–1999===
On 8 April 1997, after buying the remaining 43.5% of Roussel-Uclaf stock in early 1997,<ref>{{cite news | vauthors = Moore SD, Kamm T, Fleming C |date=11 December 1996 |title=Hoechst to seek rest of Roussel-Uclaf; expected $3.04 billion offer would add to the wave of drug-sector linkups |newspaper=The Wall Street Journal |page=A3}}<br />{{cite news | vauthors = Marshall M |date=11 December 1996 |title=Hoechst offers to pay $3.6 billion for rest of Roussel|newspaper=The Wall Street Journal |page=A8}}<br />{{cite news |agency=[[Bloomberg News]] |date=11 December 1996 |title=Hoechst to buy rest of Roussel |newspaper=[[The New York Times]] |page=D4 |url=https://www.nytimes.com/1996/12/11/business/hoechst-to-buy-rest-of-roussel.html |url-access=subscription |url-status=live |archive-url=https://web.archive.org/web/20160625124549/http://www.nytimes.com/1996/12/11/business/hoechst-to-buy-rest-of-roussel.html |archive-date=25 June 2016 }}</ref> Hoechst AG ({{USD|30|1996}} billion annual revenue) announced the end of its manufacture and sale of Mifegyne ({{USD|3.44|1996}} million annual revenue) and the transfer of all rights for medical uses of mifepristone outside of the United States to [[Exelgyn]], a new single-product company immune to antiabortion boycotts, whose CEO was former Roussel-Uclaf CEO Édouard Sakiz.<ref>{{cite news|agency=[[Bloomberg News]]|date=9 April 1997|title=Pill for abortion ends production|newspaper=[[The New York Times]]|page=D2|url=https://www.nytimes.com/1997/04/09/business/pill-for-abortion-ends-production.html|url-status=live |url-access=subscription |archive-url=https://web.archive.org/web/20160625134359/http://www.nytimes.com/1997/04/09/business/pill-for-abortion-ends-production.html|archive-date=25 June 2016}}<br />{{cite news | vauthors = Jouzaitis C |date=9 April 1997 |title=Abortion pill maker bows to boycott heat; German firm gives up RU-486 patent; little impact likely in U.S. |newspaper=Chicago Tribune |page=4 |url=https://pqasb.pqarchiver.com/chicagotribune/access/11401570.html?dids=11401570:11401570&FMT=ABS&FMTS=ABS:FT |url-status=dead |archive-url=https://web.archive.org/web/20130218193350/http://pqasb.pqarchiver.com/chicagotribune/access/11401570.html?dids=11401570%3A11401570&FMT=ABS&FMTS=ABS%3AFT |archive-date=18 February 2013 }}<br />{{cite news | vauthors = Lavin D |date=9 April 1997 |title=Hoechst will stop making abortion pill |newspaper=The Wall Street Journal |page=A3}}<br />{{cite journal |date=18 April 1997 |title=Roussel-Uclaf to transfer RU 486 rights |journal=Reprod Freedom News |volume=6 |issue=7 |page=8 |pmid=12292550}}<br />{{cite journal | vauthors = Dorozynski A |date=19 April 1997 |title=Boycott threat forces French company to abandon RU486 |journal=BMJ |volume=314|issue=7088 |page=1150 |pmid=9146386 |pmc=2126515 |doi=10.1136/bmj.314.7088.1145m}}</ref> In 1997, Gideon Richter would withdraw from efforts to manufacture mifepristone in the United States following opposition from pro-life groups, which led to Danco filing a [[breach of contract]] lawsuit.<ref>{{Cite news|url=https://www.washingtonpost.com/archive/politics/1997/06/12/abortion-pills-us-sponsor-suing-hungarian-drug-firm/f08f9b4e-36ea-45d1-aa1e-3c89f5496370/|title=ABORTION PILL'S U.S. SPONSOR SUING HUNGARIAN DRUG FIRM|date=1997-06-12|work=[[The Washington Post]] |url-access=subscription |access-date=2024-06-13|language=en-US|issn=0190-8286}}</ref> In 1999, Exelgyn won approval of Mifegyne in 11 additional countries, and in 28 more countries over the following decade.<ref name="Gynuity 2009">{{cite web|date=4 November 2009|title=List of mifepristone approval|location=New York|publisher=Gynuity Health Projects|url=http://gynuity.org/downloads/mife_approval_2009_list.pdf|url-status=dead|archive-url=https://web.archive.org/web/20110726135110/http://gynuity.org/downloads/mife_approval_2009_list.pdf|archive-date=26 July 2011|access-date=4 May 2018}}<br />{{cite web|date=4 November 2009|title=Map of mifepristone approval|location=New York|publisher=Gynuity Health Projects|url=http://gynuity.org/downloads/Mife_approval_2009_map.pdf|access-date=11 June 2010|url-status=dead|archive-url=https://web.archive.org/web/20110726135136/http://gynuity.org/downloads/Mife_approval_2009_map.pdf|archive-date=26 July 2011}}</ref>

===2000–present===
In September 2000 Danco Laboratories, a sub-licensee of the Population Council, received approval from the US [[Food and Drug Administration]] (FDA) to sell mifepristone under the brand name Mifeprex.

In 2019, the first generic form of mifepristone in the United States became available, manufactured by [[GenBioPro]].<ref>{{Cite web| vauthors = North A |date=20 August 2019|title=The first generic abortion pill just hit the US market. Here's what that means.|url=https://www.vox.com/identities/2019/8/20/20750226/abortion-pill-mifepristone-pregnancy-genbiopro-mifeprex-generic|access-date=14 July 2020|website=[[Vox (website)|Vox]]|archive-date=13 July 2020|archive-url=https://web.archive.org/web/20200713184519/https://www.vox.com/identities/2019/8/20/20750226/abortion-pill-mifepristone-pregnancy-genbiopro-mifeprex-generic|url-status=live}}</ref>

In the early 2000's, several pharmaceutical companies in China were producing mifepristone.<ref>
{{cite news
|title=Abortion Pill Maker Revealed
|date=October 13, 2000
|publisher=CBS
|url=https://www.cbsnews.com/news/abortion-pill-maker-revealed/
|access-date=March 28, 2025
}}
</ref><ref>{{cite web
|title= RU-486 Manufacturers in China
|archive-date=January 8, 2003
|url=http://www.usembassy-china.org.cn/sandt/jh.html
|url-status=dead
|archive-url=https://web.archive.org/web/20030108033353/http://www.usembassy-china.org.cn/sandt/jh.html}}</ref>