リプロな日記

中絶問題研究者～中絶ケア・カウンセラーの塚原久美のブログです

ミフェプリストンの製造会社

ごく早期の妊娠中絶に使用できるミフェプリストンという薬は、RU 486という開発名で呼ばれることもあり、このRUはフランスのRoussel Uclaf（ルーセル・ウラア）社という社名に基づくということは、以前の日記に書いた。

本日付のWikipediaによれば、この会社の業務の一部は、1994年にドイツのHoechst Schering AgrEvo GmBHに移転された。ルーセル・ウラアは1万件以上の特許を保有しているが、そのうちミフェプリストン（RU 486）が最もよく知られており、米国内におけるこの薬の特許権は、1994年にポピュレーショノ・カウンシル（Population Council）という非営利団体に寄贈されたという。

人々の健康やリプロダクティヴ・ヘルスの保障をめざす国際NGOであるPopulation Councilのサイトには、この薬がアメリカで販売された2000年までの経緯が載っている。

  • 1980 A research team at Roussel Uclaf synthesizes an antiglucocorticoid and shows that it also is a drug that fits into progesterone receptors, thus blocking the hormone needed to sustain pregnancy. The drug’s generic name is mifepristone.
  • 1982 Roussel Uclaf reports a successful initial trial of mifepristone to induce abortion, and begins years of trials in several countries to test the drug in women less than seven weeks pregnant.
  • 1983 The Population Council obtains U.S. Food and Drug Administration (FDA) approval to test mifepristone in the United States; during the next six years, over 300 women receive mifepristone at the University of Southern California in a series of dosage studies.
  • 1984 A World Health Organization–sponsored study in Sweden shows efficacy of a combination of mifepristone and a prostaglandin.
  • 1985 The U.S. National Institutes of Health begin to support research on other potential medical uses of mifepristone.
  • 1988 The French Ministry of Health announces approval of mifepristone combined with a prostaglandin for early medical abortion. Responding to months of protests from antiabortion groups, Roussel Uclaf decides to suspend marketing of mifepristone, but the French minister of health orders the drug back on the market two days later, calling it the “moral property of women.” Mifepristone is approved in China, but Roussel suspends its plan for distribution there and in other countries.
  • 1989 Mifepristone becomes available in France. In the United States, the FDA places mifepristone on its “import alert” list.
  • 1991 Mifepristone is approved for use in the United Kingdom.
  • 1992 Mifepristone is approved for use in Sweden. An oral prostaglandin is approved for use with mifepristone in France.
  • 1993 January 22: President Clinton directs the Department of Health and Human Services to “promote the testing, licensing, and manufacturing in the United States of mifepristone and other antiprogestins.”
    • April 20: In a joint announcement by the Population Council and Roussel Uclaf at the FDA, Roussel says it will license the Council to conduct a clinical trial of mifepristone, file a New Drug Application, and select a manufacturer and distributor for the United States.
    • May 27: A study published in The New England Journal of Medicine shows effectiveness of mifepristone plus an oral prostaglandin.
    • Sept. 8: Institute of Medicine report gives hope that mifepristone can be helpful in fighting a range of diseases.
  • 1994 May 16: The Council and Roussel Uclaf announce that, instead of licensing the Council, Roussel Uclaf will donate to the Council U.S. rights for all identified medical uses of mifepristone without any remuneration.
    • October: Clinical trial of mifepristone for early termination of pregnancy begins in the United States under Population Council sponsorship.
  • 1995 September: The U.S. clinical trial ends. A total of 2,121 women were enrolled in the medical abortion trial at 17 sites around the country.
  • 1996 March: The Council submits its New Drug Application to the FDA, based primarily on data from the pivotal French studies.
    • July 19: FDA Advisory Committee holds an all-day public hearing and recommends that the FDA approve use of mifepristone for medical abortion.
    • September 18: The FDA issues an “approvable” letter, saying mifepristone is safe and effective, but that the Council must provide additional information related to labeling and manufacture.
  • 1998 May: The New England Journal of Medicine publishes an article with safety and efficacy data from the Council’s U.S. clinical trial.
    • July: The Archives of Family Medicine publishes an article on acceptability and feasibility of mifepristone provision, based on the Council’s U.S. clinical trial.
  • 1999 The Population Council and its licensee, Danco Laboratories, submit labeling and manufacturing information to the FDA. Regulatory agencies approve the drug for marketing in Austria, Belgium, Denmark, Finland, Germany, Greece, Israel, the Netherlands, Spain, and Switzerland. In Europe, over 620,000 women have used mifepristone as an early option pill in combination with various prostaglandins: injectable, vaginal suppository, or oral.
  • 2000 Norway, Russia, and Ukraine approve mifepristone.
    • February: The FDA issues another approvable letter.
    • September: The FDA approves the Council’s New Drug Application for mifepristone.
    • November: Distribution of Mifeprex™ begins.

（Population Councilのサイトより）

Population Councilは、ミフェプリストンの販売をDanco Laboratoriesに委ねた。Dancoは商品名Mifeprexと名付けたこの薬を中絶薬（abortifacient)とは呼ばず、"the early option pill to end pregnancy（妊娠終了のための初期の選択肢）"という言葉を使用している。

Wikipedia（Mifepristone)によれば、中国でミフェプリストンが認可されたのは1988年で世界で最初だったが、RU社が中国への販売に及び腰であったため、1992年、中国国内でミフェプリストンの製造が開始された。

なお中国名で「息穏」と呼ばれる中国製RU 486の製造会社としては、上海華聯製薬有限公司や北京紫竹药业有限公司の名を見るが、他にもあるのかどうかは知らない。北京紫竹药业有限公司はリューマチ薬に他の薬品が混じるという事故が明るみに出ている。中国製ミフェプリストンについても、その品質を疑問視する記事がこの2月のNew York TimesやMedical Newsに載っている。

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