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Abortion pill is approved for sale in United States

BMJ 2000; 321 doi: https://doi.org/10.1136/bmj.321.7265.854/e (Published 07 October 2000) Cite this as: BMJ 2000;321:854
  1. Scott Gottlieb
  1. New York

    Amid bitter opposition from antiabortion groups, federal authorities announced that the abortion pill RU-486 has been approved for sale in the United States. The pill should be available in there within four to six weeks, according to Planned Parenthood.

    The Food and Drug Administration (FDA) approved RU-486 (mifepristone) for the termination of early pregnancy, defined as 49 days or less, counting from the beginning of the last menstrual period. The administration said it based its approval of mifepristone on data about safety and effectiveness from clinical trials in the United States and France. It is estimated that more than half a million women in Europe have used mifepristone since its debut in France 12 years ago.

    Supporters lauded the approval as a milestone, making abortion more private and improving access for women living in areas where surgical abortions are not available. Antiabortion organisations, which have fought since 1988 to keep RU-486 out of the United States, assert that the pill carries health risks for women. The FDA's announcement prompted a flurry of statements from politicians and organisations on both sides of the issue.

    Texas governor and Republican presidential candidate George W Bush called the decision wrong, saying: “I fear that making this abortion pill widespread will make abortions more and more common … As president, I will work to build a culture that respects life.”

    Vice President and Democratic presidential candidate Al Gore agreed with the FDA. “Today's decision is not about politics,” he said, “but the health and safety of American women and a woman's fundamental right to choose.”

    The National Right to Life Committee vowed to fight RU-486 through educational efforts. Spokeswoman Laura Echevarria said that the organisation would make sure “women know about the development of their unborn child, that about the time an RU-486 abortion takes place, an unborn child's heart has most likely begun to beat.”

    Mifepristone works by causing the embryo to detach from the uterine lining. To induce an abortion, the drug is taken with misoprostol, which causes contractions and aids in expelling the embryo. Under the approved regimen, a woman first takes three mifepristone pills by mouth. Two days later, she returns to the doctor to take the second drug. She returns for a follow up visit within two weeks to make sure the abortion is complete.

    Under the terms of the approval, mifepristone will be distributed to physicians who have access to ultrasonography to determine the duration of a patient's pregnancy and detect an ectopic pregnancy, which is a contraindication for use of RU-486. Physicians who prescribe mifepristone must also be able to provide surgical intervention in cases of incomplete abortion or severe bleeding, the FDA said, or they must have made plans in advance to provide such care through others. In about one of 100 women, bleeding can be so heavy that a surgical procedure will be required to stop it.

    Advocates and opponents say the abortion pill's impact could be muted by trepidation among doctors about prescribing the controversial drug. Although the drug's availability through private doctors' offices is expected to make it much harder for antiabortion activists to target abortion providers, some medical professionals may remain fearful of protesters or even violence. Some states, including Virginia, already have requirements for reporting abortions that would apply to RU-486 and make it difficult for doctors who use it to remain anonymous.

    Doctors also may shun the pill because they are not familiar with administering it or dealing with the complications that could arise, or with the counselling that would be required of them, some observers said. “The predictions for the whole thing may be a little optimistic in terms of people thinking that doctors who are not performing abortions are going to come out of the woodwork and start prescribing the pill,” said Ron Fitzsimmons, executive director of the National Coalition of Abortion Providers.

    Dr Benson Harer Jr, president of the American College of Obstetrician and Gynecologists, welcomed the FDA's decision. He said: “American women choosing to have an abortion have a new option for abortion very early in pregnancy, when it is safest. They finally have access to a drug that has been used safely for many years by other women throughout the world. No longer are American women limited to surgical abortions.

    “The decision is a relief for women and their physicians. It should increase the number of physicians offering abortion and enhance the privacy of the abortion decision. Both factors should help reduce the level of violence against physicians and their patients.

    “This decision is long overdue. Clinical trials on thousands of women here and in Europe clearly show that mifepristone when used with misoprostol for early abortion is very safe and effective.

    “The American College of Obstetricians and Gynecologists will review and address any restrictions the FDA may have imposed on this drug. But today we emphasise how important the FDA's decision is for women. The FDA is to be commended for doing what is in the best interest of the health and wellbeing of women in the United States.”

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