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A Long Journey

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The FDA's approval of the abortion pill, once known as RU 486, came after two decades of research, protests and political controversy

JANUARY 1973 Roe v. Wade decision makes abortion legal

1980 French professor Etienne-Emile Baulieu and researchers from Roussel Uclaf synthesize RU 486 (mifepristone)

1982 Roussel Uclaf reports first successful human testing of RU 486

1983 The Population Council receives FDA approval to test the drug in the U.S. During the next six years, more than 300 women receive RU 486 at the University of Southern California

SEPTEMBER 1988 French Health Ministry approves RU 486 combined with prostaglandin for medical abortion. The following month Roussel Uclaf suspends distribution because of pressure from antiabortion groups. After the ministry orders the pills back on the market, they become available the following year

JUNE 1989 President Bush issues an import ban, claiming the drug has not been studied enough and could result in widespread health problems

JANUARY 1993 Shortly after taking office, President Clinton lifts the ban imposed by the Bush Administration

MAY 1993 Success of the two-pill regimen, reported in the New England Journal of Medicine, eliminates the need for an injection. The report stirs widespread public anticipation of the abortion pill

MAY 1994 Following Clinton's suggestion, Roussel Uclaf donates the U.S. patent to the Population Council

DECEMBER 1995 The Population Council licenses distribution and manufacturing of RU 486 to Danco Laboratories

MARCH 1996 The Population Council files a new-drug application with the FDA

JULY 1996 An FDA advisory panel recommends that RU 486 be approved but also says the agency should monitor how the drug is distributed and credentialed

FEBRUARY 1997 Hungarian pharmaceutical company Gedeon Richter backs out of an agreement to make the drug

SEPTEMBER 2000 The FDA approves RU 486


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Cover Date: October 9, 2000

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