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FDA action moves RU-486 closer to use in U.S.
WASHINGTON (CNN) -- The Food and Drug Administration wants more questions answered before it gives final approval for the abortion pill sold in France as RU-486 to be marketed in the United States.
On Friday, the FDA issued an "approvable letter" to the Population Council, the nonprofit research institution that holds the U.S. patent rights for the abortion pill. The action is a step short of approval.
But the agency, which already has said the drug is safe and effective, could have rejected the Population Council's request for marketing approval.
The FDA had until Friday to respond to the request. It's not known precisely what information the FDA is seeking or how long it might be before final action. But observers said the agency most likely wants more detail on how the drug would be packaged and marketed and what directions will be provided for its use.
The letter was hailed as "another major step forward" by the company that would distribute the pill in the United States -- the Danco Group.
"The FDA letter confirms the early-option abortion pill is approvable, and it's still under review," a spokeswoman for Danco told CNN. "The company is preparing the information requested by the FDA, and they're confident they'll have what the FDA needs to approve it."
Known generically as Mifepristone, the pill causes an abortion when used in combination with the already approved drug Misoprostol.
After learning of the FDA's action, the anti-abortion rights group National Right to Life said, "This is the first time in history that the FDA is considering approval for a drug explicitly used for the purpose of destroying rather than saving a life."
"We are disappointed that they did not approve it today, but we're optimistic they still will," said Sandra Jordan, a spokeswoman for Planned Parenthood.
The pro-abortion rights group National Abortion Rights Action League said the FDA letter does not imply any incremental progress on the way to the pill's approval but is a neutral move to collect more information.
Conditional OK granted in 1996
Mifepristone is an anti-progesterone drug that blocks receptors of progesterone, a key hormone in the establishment and maintenance of pregnancy.
"Mifepristone, or the early abortion pill, is as significant a technological advance for women's health as the birth control pill was 40 years ago," said Gloria Feldt, president of Planned Parenthood.
In 1996, the FDA gave conditional approval for Mifepristone, indicating the drug was safe and effective, but it said a company should be designated to provide additional manufacturing, labeling and other information before final approval could be given.
The Population Council granted the Danco Group, a new women's health pharmaceutical company, a license to manufacture, market and distribute the drug.
After one manufacturer backed out of the project, Danco identified manufacturers willing to produce Mifepristone. The identity of the manufacturers has not been released.
How effective is RU-486?
Studies published in the New England Journal of Medicine and Archives of Family Medicine in 1998 show Mifepristone is 92 percent effective in terminating pregnancies up to 49 days in duration.
If the procedure fails, the woman can undergo a surgical abortion. Ninety-five percent of the women in the study said they would recommend the abortion pill to others.
The side effects of the early abortion procedure are similar to those of a spontaneous miscarriage: Uterine cramping, bleeding, nausea and fatigue.
The treatment involves two visits to a doctor or clinic. Following a physical exam, pregnancy test and an ultrasound exam to date the pregnancy, the woman is given the Mifepristone pill to take in the office.
Within 72 hours, the woman takes Misoprostol -- a tablet that can be taken by mouth or as a vaginal suppository. Six hours following the addition of Misoprostol, most women will complete the abortion.
In a small percentage of women, the abortion can take up to a week to complete. The woman returns to the doctor's office two weeks after taking Mifepristone for an ultrasound test to confirm the abortion is complete.
"Mifepristone gives women another option," Feldt said. "Many women prefer it because they feel it's a more natural option compared to surgical abortion. But that's not true for all women. In France for example, about half the women choose the pill and the other half choose to have a surgical procedure."
Pill's history overseas
Mifepristone/RU-486 was first approved for use in September 1988 in France. The drug was developed by the pharmaceutical firm Roussel-Uclaf.
In 1991 RU-486 was approved for use in Great Britain and in 1992, it was approved for use in Sweden.
Roussel-Uclaf will not market the drug in the United States or any other country where the company thinks the political and social conditions are unreceptive to the drug.
In 1994, the drug maker donated the U.S. patent rights for Mifepristone to the Population Council.
It's estimated that approximately 500,000 women in Europe have had medical abortions using Mifepristone
European studies show Mifepristone used at a substantially lower dose can be used as a morning after pill when administered within five days of unprotected sex.
The FDA has already approved a birth control pill combination for this same purpose. Further studies in the United States would be required before the FDA would consider approving Mifepristone for this use.
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