The Use Of Mifepristone To Terminate A Pregnancy

4306 words - 17 pages

The Use of Mifepristone to Terminate a Pregnancy

The medication "mifepristone" was invented in France by Dr. Etienne-Emile Baulieu in 1980. It is widely know as "RU-486" throughout North America. The letters is taken from the initials of the pharmaceutical company Roussel-Uclaf. The "486" is an arbitrary lab serial number. 1 It was first introduced in France, where it is called Mifegyne. ® It has been used, in combination with prostaglandin medication, to induce abortions in about 500,000 women over almost 2 decades.
Over the last fifteen years, dozens of clinical studies on RU-486 have been conducted with thousands of women in over 20 countries, including France, Britain, Spain, Germany, the Netherlands, Switzerland, the U.S., Scandinavia, and the former Soviet Union. 11 In 1999, mifespristone was approved for marketing in Austria, Belgium, Denmark, Finland, Germany, Greece, Israel, the Netherlands and Spain. 15 Danco Laboratories, the U.S. distributor expected to be selling the pill in that country by the end of 1999. 11 That did not happen; FDA finally approved the pill for U.S. distribution on 2000-SEP-28. It will be distributed under the name "Early Option Pill."

Regulation Difficulties:
In late 1988, Roussel-Uclaf started distribution of the drug in France. But they withdrew it after some of its personnel had received death threats. The French government forced the company to return RU-486 to the market. Claude Evin, the French health minister called "RU-486 the moral property of women, not just the property of the drug company."
Pro-life pressure on the U.S. Food and Drug Administration caused them to ban the importation of RU-486 into the United States until 1993. Boycotts were organized against Roussel-Uclaf, its parent company, and its American affiliates.
A non-profit, New York-based group, Population Council obtained patent rights to the pill in 1994-MAY. A clinical trial was conducted in 1994-5. Following a Food and Drug Administration hearing in 1996, the FDA Advisory Committee recommended that the FDA approved mifepristone in combination with misoprostol as a safe and effective way to end pregnancies up to 7 weeks. The FDA issued an statement in 1996-SEP, stating that mifespristone is safe and effective. However, it asked that the Population Council and its licensee provide additional information.
Under pressure from anti-abortion groups, Hoechst AF of Germany halted distribution everywhere except in England, France and Sweden. In 1997, they stopped production entirely, and gave their rights to a new French company, Exelgyn.
In 1998, Abortion Rights Mobilization manufactured and distributed small test quantities of the drug in the U.S. A spokesperson said "We keep our place secret because of the danger that someone will throw a bomb through the window...It's sad, but that's the way it is."
In 1997-APR, the Canadian rights to distribute the pill were assigned to Exelgyn. The Canadian government does not approve...

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