Ru-486 is used widely in the European countries as an abortifacient but it has yet to be approved by the FDA for usage in the U.S.. In 1991, the Bush administration, allegedly in response to political pressure from conservative and anti-abortion groups, imposed an import alert on the drug, banning it from being brought into the U.S. for personal use as an abortifacient. Serious movement to lift the ban started shortly after Bill Clinton took office as president. In early 1993, officials at the FDA along with Secretary of Health and Human Services Donna E. Shalala began negotiations with Roussel and Population Council, which had been conducting abortifacient research on the drug since the early1980's.
In April 1993, the White House announced that the French company Russel Uclaf, would agree to transfer the rights to RU 486 to the council. The final agreement was signed and went into effect May 15. Details of the agreement, however, are proprietary information between Roussel Uclaf and the Population Council and have not been released.
Why do we want this drug so badly ? And why is Russel Uclaf agreeing to give over its rights to it? RU-486 has two important applications. It is an abortifacient and is a potential treatment for other diseases such as breast cancer, endometriosis, meningioma, and Cushing's syndrome. Many research scientists in the U.S. are studying the drug for its potential values. This drug has to be obtained from Roussel Uclaf directly. Roussel Uclaf has ben very cooperative in this matter. Its parent company Hoechst AG, based in Germany, however, is putting pressure on Roussel Uclaf to curtail its involvement with the drug. This matter stems from the religious convictions of its leaders.
RU-486 is best known for its abortifacient value. It is an antiprogestin. It is a superhormone that competes with Progesterone, the harmone responsible for maintaining pregnancy. Because RU-486 has a higher affinity for the progesterone receptor than progesterone itself, it outcompetes progesterone and binds to the receptor but does not give the same hormone response. Without the proper signals from the progesterone receptors, the body can not maintain the pregnancy. The uterine lining is then shed and the pregnancy is terminated. Researchers no longer refer to the drug as RU-486 because of the negative connotations it carries as an "abortion pill", instead it is now refer to by its generic name, mifepristone. Because RU-486 has not yet been approved by FDA for any use within the U.S., scientists, with data provided by the patent owner (Roussel Uclaf), must submit an investigational new drug (IND) application with FDA to obtain it for research or clincial studies. But once the drug is approved for use as an aboritfacient in the U.S., the paperwork and red tape involved in procuring its use in other studies should be greatly reduced, according to many researchers. Clinical trials are expected to begin clinical trials of RU 486 as an emergency contraceptive and according to FDA and council officials, this means that RU 486 could be available in the U.S. in two years or less. However, even with the approval for RU-486 as an abortifacient, approval for other uses would not be covered. The FDA expects the Population council to choose a company to manufacture the drug that will not be deterred by pressure from anti-abortion groups