· The drug’s name RU-486 comes from Roussel-Uclaf and 486 was the random serial number assigned to it by the company.

· The drug was put into clinical trials in many European countries such as France, Britain, Spain, Germany, The Netherlands, Switzerland, Scandinavia, and the former Soviet Union from the time it was developed in 1980 for at least the following 15 years.

· In 1983 the Population Council received U.S. Food and Drug Administration (FDA) approval to test mifepristone in the United States; during the next six years, over 300 women received mifepristone at the University of Southern California in a series of dosage studies.

· In late 1988, RU started distribution of the drug in France, but withdrew it after personnel received death threats and experienced months of anti-abortion protests.  The French government forced the company to return the drug to the market within two days.

· In 1989, the Bush administration banned the importation of mifepristone for personal use.

· European countries continued the process of approving mifepristone, with the United Kingdom approving the drug in 1991 and Sweden in 1992.

· With a new president in 1993, the Clinton administration lifted the ban on personal importation of mifepristone.  President Clinton directed Health and Human Services to "promote the testing, licensing, and manufacturing in the U.S. of mifepristone and other antiprogestins."

· After extensive negotiations Roussel-Uclaf donated the US patent rights to the Population Council in May of 1994.  By October, clinical trials of mifepristone for early termination of pregnancy had begun in the United States under Population Council sponsorship.

· During 1994 and 1995 the Population Council conducted clinical trials in 17 US cities.  Over 2000 women participated in the trials.

· In 1996, the Population Council submitted a New Drug Application for mifepristone-misoprotol abortions to the FDA.  Six months later, the FDA issued an “approvable” letter acknowledging the safety and efficacy of the drug regimen but the Council must provide additional information on its labeling and manufacturing.  The US Department of Health and Human Services also released a press statement at this time.

· In 1997, the proposed Hungarian manufacturer backed out most likely because of fear of boycotting and demonstrations by pro-life groups.

· In 1999 the Population Council and its licensee, Danco Laboratories, submitted labeling and manufacturing information to the FDA. Regulatory agencies approved the drug for marketing in Austria, Belgium, Denmark, Finland, Germany, Greece, Israel, Luxembourg, 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.

· In 2000, the drug is approved in the Ukraine, Russia, and Norway.

· On September 28, 2000 the FDA approved the pill for distribution and it became first available in December of 2000.

· RU-486 is distributed by Danco Laboratories under the name Mifeprex©

· RU-486 is still not available in Canada due to the fact that the distributor Exelgyn has not sought permission from Health Canada.  The Canadian government can therefore not approve the use of RU-486.  The provincial government of British Columbia has been pressuring the federal government to approve RU-486 due to the increase of violence against abortion clinics and providers.

References:
www.religioustolerance.org/aboru486.htm
www.populationcouncil.org/mifeprex/chrono.html
www.kff.org/content/2000/20000613a/IssueBrief.PDF