Advocates of the controversial pill have faced numerous roadblocks in trying to make it available to American women. The deadline for the FDA decision is Friday. The journey to this week's FDA action has been a long one for the drug, whose medical name is mifepristone.
Twenty years ago, Roussel-UCLAF, a French company, developed the drug, also known as RU-486. It was later made available to women in France, the United Kingdom and Sweden.
In 1993 the Clinton administration lifted a ban imposed by the Bush administration that prevented American women from importing RU-486.
French drug maker refuses U.S. distribution
Because of the political controversy over abortion, Roussel refused to distribute the drug in the United States. In 1994 the company donated the patent rights to the Population Council, a New York-based international organization, so that non-profit family planning group could study it and find a willing manufacturer.
"The studies in the U.S. were just a continuation of studies that have been done in Europe," said Dr. Mitchell Creinen, of the University of Pittsburgh, Pennsylvania, "and didn't show much difference than what we already knew."
"That was that mifepristone, combined with another medication like misoprostol, is a safe and effective option for early abortion," he said.
Misoprostol, a hormone-inducing drug, is already FDA approved for the treatment of ulcers.
Trials show drug's effectiveness, says council
The council says it is estimated that about 500,000 women in Europe have had medical abortions using the mifepristone regimen. Between 1994 and 1995, 2,121 women in Planned Parenthood and other U.S. health centers participated in clinical trials of the drug sponsored by the council.
The trials showed the drug to be effective in terminating 92 percent of pregnancies of up to 49 days' duration. In the same trials, 96 percent of women said they would recommend the mifepristone method to others and, even among women for whom the method failed, 86 percent said they would recommend it to others.
In 1996 the FDA issued an "approvable letter" for mifepristone that acknowledged the drug was safe and effective. But the administration withheld marketing approval until manufacturing and labeling information was provided.
That produced a major glitch because the council had not yet found a company to make the drug.
Manufacturer found, but name remains secret
In 1997 there was further delay for the pill's advocates because a manufacturer, who had agreed to produce mifepristone for American women, backed out.
Danco Laboratories, a new women's health pharmaceutical company, stepped in and plans to market mifepristone. A manufacturer has been found, but its name remains a secret.
Now the ball lies in the FDA's court and the administration is expected to take one of three actions: deny approval; extend the regulatory review process; or grant marketing approval.
If approval is given, it could come with restrictions, such as requiring doctors to register if they perform abortions with the drug. These physicians would also have to be able to perform surgical abortions and have hospital privileges within an hour's drive.
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