FDA approves use of abortion pill RU-486

By LAURAN NEERGAARD

Associated Press

WASHINGTON – The Food and Drug Administration today approved U.S. use of the abortion pill RU-486, a major victory for those who battled for 12 years to bring the early-abortion method to this country.

Proponents say the pill, which has been used by millions of women in 13 countries, could transform abortion in the United States by making it more accessible and more private. But it can be used only in the earliest days of pregnancy.

It could be available to doctors within a month.

“For those who choose to have an early termination of their pregnancy, this is a reasonable medical alternative,” said FDA Commissioner Jane Henney.

Anti-abortion organizations have fought to keep RU-486 out of the United States since the drug debuted in France in 1988. They pledged to continue the fight.

“We will not tolerate the FDA’s decision to approve the destruction of innocent human persons through chemical abortion,” said Judie Brown of the anti-abortion American Life League.

Worried about anti-abortion violence that has sprung up in recent years, the FDA has increased security in some of its offices and, in an unusual move, Henney is keeping secret the names of the medical officers who reviewed the drug.

“The climate around the reproductive-rights issue and personal safety issues are in our minds,” she said.

To ensure the pill is used accurately and safely, the FDA mandated that women be given special brochures called “MedGuides” explaining who is eligible for a pill-caused abortion and what side effects to expect and that they must make three trips to the doctor for the procedure.

RU-486, now known by its chemical name mifepristone, can be used only within 49 days of the beginning of the woman’s last menstrual period. 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 returns for a follow-up visit within two weeks to make sure the abortion is complete.

The FDA will allow mifepristone to be distributed only to doctors trained to accurately diagnose the duration of pregnancy and to detect ectopic, or tubal, pregnancies, because those women cannot receive mifepristone.

Also, the FDA restricted mifepristone’s use to doctors who can operate in case a surgical abortion is needed to finish the job or in cases of severe bleeding – or to doctors who have made advance arrangements for a surgeon to provide such care to their patients.

Studies show mifepristone is 92 percent to 95 percent effective in causing early abortion, by blocking action of a hormone essential for maintaining pregnancy. Without that hormone, progesterone, the uterine lining thins so an embryo cannot remain implanted and grow.

The pill-induced abortion can be painful, causing bleeding and nausea. Heavy bleeding is a potentially serious side effect but one the FDA determined is rare. In safety testing of the first 2,100 American women who took mifepristone, four bled enough to need a transfusion.

A small New York company, Danco Laboratories, will market mifepristone under the brand name Mifeprex. It should be available in about a month. Abortion providers say the pill-caused abortion should cost the same as surgical abortion, but a Danco spokeswoman refused to confirm that today.

The FDA’s decision, coming in the midst of the presidential election campaign, is sure to generate fierce new controversy. Republican candidate George W. Bush opposes abortion; his father’s administration banned RU-486 from this country in 1989. The pro-choice Clinton-Gore administration worked for seven years to bring mifepristone here.

Proponents argued that a pill-caused abortion offers a surgery alternative that feels more like a miscarriage and typically is offered earlier in pregnancy than surgical abortion.

Bowing to that pressure, French manufacturer Roussel-Uclaf in 1994 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 and effective abortion method in 1996, final approval was delayed until now because Danco, created to market the drug, had trouble meeting federal manufacturing and labeling requirements.

The vast majority of today’s 1.3 million annual U.S. abortions are surgical, although doctors in 1995 began publicizing the fact that a drug already sold to treat cancer, methotrexate, also could be used to induce abortion.

Health experts say mifepristone won’t increase abortions – that didn’t happen in Europe. But the FDA’s formal approval may encourage more doctors who don’t offer surgical abortions to offer the pill, thus making it easier for women, particularly in rural areas, to get an abortion without traveling hundreds of miles or entering surgical clinics often staked out by protesters.

The National Abortion Federation, which accredits abortion providers, said 240 of its member clinics were already prepared to offer Mifeprex, and it is training other physicians in how to use the pill.