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Mifepristone

A Chronology In Brief of The Fight To Make RU 486 Available To U.S. Women

Mifepristone -- formerly known as RU486, the French Abortion Pill -- a medication that can be used for safe, effective early abortion. RU486 may also be effective in treating fibroid tumors, endometriosis, Cushing's Syndrome, meningiomas, some types of breast cancer, and a myriad of other diseases and conditions that primarily affect women.

1983
Clinical trials on the use of RU486 as a method of early abortion begin in the United States at the University of Southern California.

1988
RU486 becomes available in France in October 1988, after the French Minister of Health declares RU486 "the moral property of women" and orders Roussel Uclaf to return RU486 to the market following the company's decision to withdraw the drug in the wake of anti-abortion pressure.

Anti-abortion forces threaten Roussel Uclaf's parent company, Hoechst AG, with economic reprisal if RU486 is marketed in the United States.

1989
In March, Hoechst informs abortion opponents that "it is not our intention to market or distribute RU486 outside of France."

The U.S. Food and Drug Administration responds to pressure from anti-abortion Congressional representatives by banning the importation of RU486 for personal use.

Feminist Majority Foundation leaders travel to France to assess the potential of RU486. Their meetings reveal the wide range of potential benefits for women. The Feminist Majority Foundation launches the nation's largest public education drive on RU486, the Campaign for RU486 and Contraceptive Research.

JULY 1990
A ten-member Feminist Majority Foundation delegation, comprised feminist leaders and prominent scientists, travels to Europe to meet with officials of Roussel Uclaf and Hoechst AG, respectively, to urge U.S. introduction of RU486. At these meetings, which include a five-hour discussion with Roussel CEO Edouard Sakiz, the delegation presents over 115,000 petitions from American citizens in support of RU486.

NOVEMBER 1990
Congressman Ron Wyden holds hearings on RU486 before the House Small Business Committee. Scientists testify that the import alert has hindered research on non-abortion indications of RU486, including its use as a possible treatment for breast cancer. Following these hearings, Congressman Ron Wyden introduces legislation to remove the import alert.

FEBRUARY 1991
The American Association for Advancement of Science (AAAS) endorses the testing and use of RU486. Having secured the AAAS support, the Feminist Majority Foundation successfully pursues RU486 endorsements from almost every scientific and medical organization in the country. In addition, the Feminist Majority Foundation collects over 3000 individual scientists petitions.

MAY 1991
New Hampshire becomes the first state in the nation to pass a resolution urging the commencement of clinical trials of RU486 in that state. Subsequent RU486 resolutions are passed in other state legislatures.

SEPTEMBER 1991
Feminist Majority Board Chair Peg Yorkin announces an historic $10 million dollar endowment and gift to the Feminist Majority Foundation and Fund. The donation is especially targeted for the Foundation's Campaign for RU486 and Contraceptive Research.

FEBRUARY 1992
A third Feminist Majority Foundation delegation meets with officials from Hoechst AG to urge U.S. marketing of RU486, delivering an additional 110,000 petitions supporting RU486.

APRIL 1992
Feminist Majority Foundation announces Web of Influence Campaign to educate the public on U.S. companies and institutions that do business with Hoechst AG and Roussel Uclaf and to encourage those companies to ask that RU486 be distributed here.

Feminist Majority Foundation holds RU486 picket at Treviera Twosome race in New York City, sponsored by Hoechst Celanese and Nike.

JULY 1992
In the first direct challenge to the FDA import alert on RU486, a pregnant American woman, Leona Benten, returns from Europe with a prescription of RU486. Customs officials seize the RU486 upon the arrival of Benten and Larry Lader of Abortion Rights Mobilization at JFK Airport. Despite a lower court ruling in favor of Benten's right to RU486, the Supreme Court refuses to order Customs to return the RU486 to Benten or the FDA to overturn the import ban.

OCTOBER 1992
New England Journal of Medicine study concludes that RU486 is a safe, effective post-coital contraceptive, which has fewer side effects and is easier to use than the current "morning-after" pill.

NOVEMBER 1992
Clinton is elected as President of the United States. During the campaign, Clinton pledged his support for bringing RU486 to this country.

The Feminist Majority Foundation sends letters to Roussel Uclaf and Hoechst AG informing them that with Clinton's election and the election of more women and pro-choice members of Congress the political obstacles to RU 486 in this country had effectively been removed.

DECEMBER 1992
The FDA announces that a review of RU486 for U.S. distribution could be completed in as short a time as six months. FDA Commissioner David Kessler writes to Roussel Uclaf encouraging the company to submit an application to license RU486 in the U.S.

JANUARY 1993
President Clinton issues an executive order instructing the FDA to re-evaluate the RU486 import alert and directing the Secretary of Health and Human Services to "assess initiatives... [that can] promote the testing, licensing, and manufacturing of RU486 or other antiprogestins."

FEBRUARY 1993
Larry Lader announces that the Peiking Union Medical College has given Abortion Rights Mobilization permission to test the Chinese clone of RU486.

APRIL 1993
Larry Lader, along with Eleanor Smeal of the Feminist Majority, announces a strategy to remove Roussel Uclaf's patent on RU 486, using an existing law that allows Congress to remove patents on products not being marketed in the U.S. Lader also announces that the RU 486 compound has been replicated by scientists in New York State.

At a press conference sponsored by Physicians for RU486, Rep. Ron Wyden promises to hold a Congressional hearing on removing the RU486 patent from Roussel Uclaf if there is no agreement to commence U.S. trials in three months.

Hoechst AG and Roussel Uclaf say they will allow the Population Council to test and manufacture RU 486. However, Hoechst AG continues to prohibit Roussel Uclaf from selling RU 486 to a U.S. distributor in the interim, while an American manufacturer is established and gains FDA approval. These restrictions could further delay making RU 486 available.

Stating that "unnecessary delays could lead to indefinite delays," Feminist Majority President Eleanor Smeal sends a letter To Hoechst AG CEO Wolfgang Hilger urging the company to permit the sale of RU 486 to the U.S. during the interim period. Smeal's letter was accompanied by another installment of 100,000 RU486 petitions.

MAY 1993
New England Journal of Medicine reports that RU486, in combination with misoprostol in pill form, is now 99% effective in terminating pregnancy during the first nine weeks. This oral prostaglandin, already used in France, replaces prostaglandin injection.

JUNE 1993
The Feminist Majority Foundation outnumbers RU486 opponents by 5-1 at a demonstration in front of the French Embassy called by Operation Rescue.

SEPTEMBER 1993
The Institute of Medicine releases a report recommending immediate submission to the FDA of a New Drug Application for the use of RU486 as a method of early abortion and calling for expedited U.S. research on the multiple medical uses of RU486 and other antiprogestins.

OCTOBER 1993
Negotiations to allow the Population Council to seek FDA approval for RU 486 stall. The Feminist Majority continues its "No More Delays" petition campaign to urge Hoechst AG to make RU486 available to American women immediately.

JANUARY 1994
Marking the tenth month of negotiations between the Population Council and Roussel Uclaf, The Feminist Majority Foundation ships another 50,000 petitions to Hoechst AG on the 20th anniversary of the Roe v. Wade Supreme Court decision legalizing abortion.

FEBRUARY 1994
British health authorities allow Marie Stopes Clinic in London to administer RU 486 to American women who travel to Europe for the early abortion procedure.

APRIL 1994
Health and Human Services Secretary Donna Shalala sets May 15 as the deadline for conclusion of Population Council and Roussel Uclaf negotiations. Congressman Wyden schedules a May 16 RU486 hearing.

MAY 1994
On May 16, Roussel Uclaf assigns its U.S. patent rights for RU 486 without remuneration to the Population Council. Since this drug will not be licensed or developed in the U.S. by Roussel Uclaf, it no longer will be called RU486, but instead will be referred to by its scientific name, Mifepristone.

Population Council plans next steps of conducting clinical trials on early abortion use, identifying a manufacturer, and winning FDA approval.

SEPTEMBER 1994
Feminist Majority Foundation, in cooperation with the Population Council, announces the establishment of a revolving fund to raise money for Mifepristone clinical trials and future anti-progestin research.

OCTOBER 1994
The Population Council begins clinical trials on mifepristone. Trials generate interest from large numbers of women. Concluded successfully in Winter 1995, the trials involve 2100 women at a dozen sites

WINTER 1995
The Population Council successfully concludes clinical trials for mifepristone at over a dozen sites around the US, involving 2100 women.

APRIL 1995
Dr. Faina Rose announces study results showing that mifepristone inhibits the growth of cancer cells.

Dr. David Weiner announces that mifepristone effectively prevents activation of the GRII receptor. By blocking this glucocorticoid receptor, mifepristone may prevent the cell infection and subsequent replication of the HIV virus.

MARCH 1996
The Population Council submits FDA New Drug Application for mifepristone as an early abortion method.

JULY 1996
The FDA Advisory Committee on Reproductive Health Drugs holds mifepristone safety and efficacy public hearings. After hearing public and scientific testimony, including testimony from the Feminist Majority Foundation, the Advisory Committee recommends approval of mifepristone.

SEPTEMBER 1996
The FDA takes the next step in the approval process by issuing an "approvable" letter to the Population Council in response to mifepristone NDA application.

APRIL 1997
Hoechst AG turns over worldwide (non-U.S.) patent rights for mifepristone to Dr. Edouard Sakiz, whose new company, Exelgyn, will distribute the compound as a method of early abortion and will begin testing on the drug's other indications.

JANUARY 1998
Abortion Rights Mobilization announces expansion to U.S. clinical trials on their RU486 clone. To date, 1600 women have been treated at 12 sites.

Advances/Neogen, the commercial entity licensed by the Population Council to market mifepristone in the U.S., makes arrangements for the manufacture and distribution of this long-awaited medical breakthrough.

DECEMBER 1999
The Feminist Majority Foundation is awarded sole responsibility for distributing mifepristone for compassionate use patinets, who have received FDA approval for single patient INDs. Single-patient INDs can be approved for patients who suffer from serious or life-threatening diseases and conditions for which no other treatment is available, such as meningioma (brain tumors).

FEBRUARY 1100
The FDA issues a second "approvable" letter. FInal approval is anticipated later in 1100.

JUNE 1100
Women's rights groups launch emergency campaign to urge FDA to reject unnecessary restrictions that could severely limit women's access to mifepristone.

SEPTEMBER 1100
On September 28 mifepristone is approved by the FDA and will be marketed by Danco Laboratories under the trade name Mifeprex.

RU 486 and Contraceptive Research