FDA Approves Abortion Pill
B O S T O N, Sept. 27, 2000 -- The Food and Drug Administration todayapproved U.S. use of the abortion pill RU-486, a major victory forthose who battled for 12 years to bring the early-abortion methodto this country.
Proponents say the pill, which has been used by millions ofwomen in 13 countries, could transform abortion in the UnitedStates by making it more accessible and more private. But it can beused only in the earliest days of pregnancy.
It could be available to doctors within a month.
FDA Issues Some RestrictionsAnti-abortion organizations have fought to keep RU-486 out ofthe United States since the drug debuted in France in 1988. Theypledged to continue the fight.
To ensure the pill is used accurately and safely, the FDAmandated that women be given special brochures called “MedGuides”explaining who is eligible for a pill-caused abortion and what sideeffects to expect, and that they must make three trips to thedoctor to undergo the procedure.
RU-486, now known by its chemical name mifepristone, can be usedonly within 49 days of the beginning of the woman’s last menstrualperiod. The woman takes three mifepristone pills. Two days later,she returns to the doctor to swallow a second drug, misoprostol,that causes uterine contractions to expel the embryo. She returnsfor a follow-up visit within two weeks to make sure the abortion iscomplete.
The FDA will allow mifepristone to be distributed only todoctors trained to accurately diagnose the duration of pregnancyand to detect ectopic, or tubal, pregnancies, because those womencannot receive mifepristone.
Also, the FDA restricted mifepristone’s use to doctors who canoperate in case a surgical abortion is needed to finish the job orin cases of severe bleeding — or to doctors who have made advancearrangements for a surgeon to provide such care to their patients.
To Be Marketed as MifeprexStudies show mifepristone is 92 percent to 95 percent effectivein causing early abortion, by blocking action of a hormoneessential for maintaining pregnancy. Without that hormone,progesterone, the uterine lining thins so an embryo cannot remainimplanted and grow.
The pill-induced abortion can be painful, causing bleeding andnausea. Heavy bleeding is a potentially serious side effect but onethe FDA determined is rare. In safety testing of the first 2,100American women who took mifepristone, four bled enough to need atransfusion.
A small New York company, Danco Laboratories, will marketmifepristone under the brand name Mifeprex. It should be availablein about a month. Abortion providers say the pill-caused abortionshould cost the same as surgical abortion, but a Danco spokesmanrefused to confirm that today.
But abortion-rights proponents pushed the FDA to approvemifepristone, arguing a pill-caused abortion offers a surgeryalternative that feels more like a miscarriage and typically isoffered earlier in pregnancy than surgical abortion.
The FDA’s decision, coming in the midst of the presidentialelection campaign, is sure to generate fierce new controversy.Republican candidate George W. Bush opposes abortion; his father’sadministration banned RU-486 from this country in 1989. Thepro-choice Clinton-Gore administration worked for seven years tobring mifepristone here.
Declared Safe Back in 1996
In 1994, French manufacturer Roussel-Uclaf turned over U.S.rights to the drug to the nonprofit Population Council of New York,which launched U.S. clinical trials needed for FDA clearance.Although the FDA actually declared mifepristone a safe andeffective abortion method in 1996, final approval was delayed untilnow because Danco, created to market the drug for the PopulationCouncil, had trouble meeting federal manufacturing and labelingrequirements.
The vast majority of today’s 1.3 million annual U.S. abortionsare surgical, although doctors in 1995 began publicizing the factthat a drug already sold to treat cancer, methotrexate, also couldbe used to induce abortion.
Health experts say mifepristone won’t increase abortions — thatdidn’t happen in Europe. But the FDA’s formal approval mayencourage more doctors who don’t offer surgical abortions to offerthe pill, thus making it easier for women, particularly in ruralareas, to get an abortion without traveling hundreds of miles orentering surgical clinics often staked out by protesters.
The National Abortion Federation, which accredits abortionproviders, said 240 of its member clinics were already prepared tooffer Mifeprex, and it is training other physicians in how to usethe pill.