A Long Journey
By Daniel S. Levy
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
|