ommended 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 drugs unless they permission is first sought from Health Canada by the manufacturer. This has not happened. However, with the increase in violence against abortion clinics and abortion providers, the provincial government of British Columbia has been pressuring the federal government to approve RU-486 for use in Canada. The federal government responded in early 1998 by sending a letter to Exelgyn, indicating that the political climate in Canada was such that their pill would get a fair hearing. 7
On 1998-JUN-24, the U.S. House passed a bill to bar approval of RU-486 by the Food and Drug Administration. The vote was 223 to 202. Tom Coburn (R-OK) said that if the pill were approved, it would be "killing babies". Also, he said that it would violate the FDA's directive of approving drugs that are "safe and effective." The bill was never signed into law.
The medication is expected to be generally available in the U.S., with the exception of Wal-Mart pharmacies