WASHINGTON — The Food and Drug Administration announced Wednesday that it intends to approve the controversial abortion pill RU-486, an action that ultimately could result in profound changes in the nature of abortion in this country.
The new pill will enable women to have abortions much earlier in their pregnancies than they can now.
It also will make a fundamental shift in the abortion network, enabling many pregnant women to avoid going to clinics or hospitals for abortions and to handle the procedure instead from the privacy of a physician's office.
That shift, in turn, is likely to change the political battle between abortion foes and supporters by making it more difficult for opponents to find the doctors and facilities involved in ending pregnancies. But those involved in manufacturing RU-486 might be added as targets of protest.
The FDA sent a letter Wednesday to the Population Council, a New York-based reproductive biomedical research and policy organization that holds the patent to RU-486 in the United States, saying that the two-drug combination is safe and effective.
The letter also said additional labeling and manufacturing information will be required before the FDA will grant a final OK but that approval is expected soon. The drug is likely to be on the market sometime next year, the Population Council said.
The council, which was given the rights to the drug combination by its French manufacturer, Roussel-Uclaf, said it is confident that it can provide the FDA with the additional information needed, and it praised the agency's announcement as "another major step in the long and complex process" to make RU-486 "available to American women as it is to women in other countries."
Roussel-Uclaf, under pressure from abortion opponents, had been reluctant to seek marketing approval in the United States and, in a highly unusual move, had donated the patent to the council. The council sponsored its own clinical trials here and sought FDA approval on its own.
In July, an FDA advisory committee deemed RU-486 safe and effective and recommended that it be licensed.
Sandra Waldman, a council spokeswoman, said the drug regimen would be available "sometime in 1997" but declined, presumably for security reasons, to identify the company or companies that will manufacture it or to disclose their locations.
Advances in Health Technology, a Washington-based nonprofit reproductive health company, will oversee the drugs' manufacture and distribution but will not actually make the product, Waldman said.
"We've been at this for awhile and no one said it would be easy--and it hasn't been," Waldman said. "It's been very complex. But we have found companies willing to be involved. There's still work ahead and we're going ahead."
The RU-486 combination is mifepristone used in combination with misoprostol, and it must be taken under a physician's supervision.
Essentially, mifepristone induces a miscarriage by blocking the hormone progesterone, which is necessary to maintain a pregnancy.
In a doctor's office, the woman takes three 200-milligram tablets of mifepristone, and returns two days later for two 200-milligram tablets of misoprostol, which causes uterine contractions. She remains for four hours, under observation, to ensure against possible adverse side effects, such as excessive bleeding, nausea and cramping.
Within 24 hours, if the combination is successful, the embryo is expelled, as in a miscarriage. If the regimen fails, a surgical abortion would be necessary. In two French studies involving 2,480 women no more than seven weeks pregnant, RU-486 worked in about 19 out of 20 cases.
The RU-486 procedure, often referred to as "medical" abortion, is not expected to replace surgical abortion, nor is it expected to have a noticeable impact on the number of abortions--currently about 1.5 million--that occur annually in this country.
"Some women will want a surgical abortion because it is over quickly," Waldman said. "This [RU-486] is not a foolproof method. It sometimes fails, in which case a woman still needs a surgical abortion. But anyone who can handle a miscarriage ought to be able to handle a medical abortion."
The cost of the drug will be set by the manufacturer, not the Population Council. The cost is expected to be about the same as many surgical abortions--about $300. Many health plans cover surgical abortions and are expected to cover the RU-486 method.
Unlike surgical abortions, which cannot be performed earlier than six weeks into a pregnancy, the drugs provide an opportunity for women to end their pregnancies much earlier.
Results from U.S. studies show that the drugs are successful up to 63 days into pregnancy, according to Waldman. They are believed to be less effective if they are used later in pregnancy. "At the beginning of a pregnancy, progesterone is at a lower level--the later you go, the harder it is to block it," Waldman explained.