ABORTION PILL
September 28, 2000

After this background report, Gloria Feldt of Planned Parenthood and Laura Echevarria of the National Right to Life Committee discuss the Food and Drug Administration's approval of RU-486. The Health Unit is a partnership with the Henry J. Kaiser Family Foundation.

July 18, 2000: Abortion politics and the 2000 campaign. Sept. 2, 1998: FDA Approves the "morning after pill." Sept. 19, 1996: A discussion on FDA's tentative approval of RU-486. Browse the NewsHour's coverage of health.     Planned Parenthood National Right to Life Committee Food and Drug Administration information on mifepristone

MARGARET WARNER: Today's decision to approve the abortion pill, RU-486, was characterized by FDA Commissioner Jane Henney as giving women new choices. DR. JANE HENNEY, FDA Commissioner: FDA's approval today of this drug, mifepristone, essentially is the first medical alternative for early termination of pregnancy. So for women who are making a decision to terminate their pregnancy in those first 49 days now have a choice -- whether it will be the more traditional surgical approach or this medical alternative. MARGARET WARNER: Abortion opponents have fought for more than a decade to keep this drug, already available in Europe, out of the U.S. market. The drug, also known as mifepristone, can be used only within seven weeks of the patient's last menstrual period. A woman takes three mifepristone pills, which block a hormone, progesterone, that's needed to maintain pregnancy. Two days later, she returns to the doctor to take another, already approved drug, misoprostol. That drug triggers uterine contractions that expel the embryo. Under the new FDA guidelines, the woman must see her doctor a third time, within two weeks, for follow-up to make sure the abortion is complete. Side effects include bleeding, cramping and nausea. And in about 5 percent of the cases in U.S. clinical trials, surgery was required to complete the abortion procedure. Nearly half a million women have used the drug in Europe in the 12 years since it was introduced in France by the pharmaceutical firm, Rousell-Uclaf. SPOKESPERSON: Research in France has shown that the majority of women prefer this non-invasive technique of early pregnancy termination. MARGARET WARNER: But amid political pressure, the firm decided not to market RU-486 in the U.S. Instead, it donated U.S. rights to a non-profit research group, the Population Council. The Council contracted with Danco Laboratories to market the pills. The drug's fate in the U.S. has been mired in abortion politics from the outset. In 1989, President Bush banned its import into the U.S. Four years later, President Clinton asked the FDA to reconsider. PRESIDENT CLINTON: Here in the United States, RU-486 has been held hostage to politics. It is time to learn the truth about what the health and safety risks of the drug really are. MARGARET WARNER: The FDA gave the drug preliminary approval in 1996, calling it safe and effective in terminating early pregnancies. But the agency said additional manufacturing and marketing concerns had to be addressed before final approval could be given. Today, in granting that final approval, the FDA added several requirements. DR. JANE HENNEY: The doctor has to be able to provide surgical... have the requisite surgical skills, if those are needed, to handle any problems that may arise, or to have a physician that they can refer to if those kind of interventions are needed. There are very strict requirements about where this drug will be stored and accounted for and the like to make sure that those doctors who desire to prescribe this drug are under obligations to the company for its use for its intended purpose. MARGARET WARNER: RU-486 will be marketed under the brand name Mifeprex, and is expected to be available within a month.