B O S T O N, Sept. 28, 2000 -- Changing the course of abortion practice in the United States, women will soon be able to terminate an early pregnancy with the pill RU-486, or Mifeprex, now that the Food and Drug Administration has approved its use today.
The pill has been used by more than a half-million women in Europe for the past decade, but has not been been available for the 1 million American women who have a surgical abortion annually. It is expected to be available here within four weeks.
“This is a medical milestone,” says Vicki Saporta, a spokeswoman for the Washington, D.C.-based National Abortion Federation, which accredits abortion providers. “Today’s approval is a victory for all American women. At long last, science has triumphed over politics.”
“It is an important day in women’s health care,” says Dr. Richard Hausknecht, medical director of Danco Laboratories in New York City, the company distributing the drug. “American women have a safe and effective early option for ending pregnancy.”
Anti-abortion groups denounced the decision. “We will not tolerate the F.D.A.’s decision to approve the destruction of innocent human persons through chemical abortion,” said Judie Brown of the anti-abortion American Life League.
The approval is widely expected to bring the drug out of abortion clinics and into the offices of family physicians and gynecologists, as many doctors who do not provide surgical abortions say they plan to prescribe the medication.
How Mifeprex Will Work Doctors will give women a guide explaining how the drug works and will give them all their dosages of the pill in their offices. Women will sign a consent form to ensure they understand what may happen when they take the pill.
The pill, mifepristone, which must be taken within seven weeks of a woman’s last period, blocks progesterone, a hormone needed to sustain pregnancy. After taking the initial dose, she will return to the doctor two days later, where she will receive a second drug, misoprostol, which will cause the embryo to be expelled.
A third visit to the physician will be required within 14 days to confirm that the pregnancy has been terminated. When taken this way, the drug has been shown to have a 92 percent to 95 percent success rate.
When the drugs fail to work, a surgical procedure may be necessary to complete the abortion.
Typically, the pill will cause a woman to have bleeding and spotting for around nine to 16 days. Some side effects are nausea and headaches.
Because the pill drops off in effectiveness after 49 days, the FDA only approved it for use by doctors who have some experience in accurately dating a pregnancy. Physicians will also be required to ensure that a patient have access to emergency medical facilities, if necessary.
No Substantial Restrictions FDA did not place restrictions on the pill that abortion-rights activists feared, such as requiring doctors either to be surgical abortion practitioners or to be located within an hour of an emergency room.
“The approval of mifepristone is the result of the FDA’s careful evaluation of the scientific evidence related to the safe and effective use of this drug,” says Dr. Jane E. Henney, the FDA commissioner. “The FDA’s review and approval of this drug has adhered strictly to our legal mandate and mission as a science-based public health regulatory agency.”
The FDA will, however, require the Population Council, which controls the U.S. patent rights to RU-486, to sponsor additional post-marketing trials of the drug in order to track patient outcome and compliance with the signing of consent forms.
“Some of the restrictions that were contemplated would have restricted physicians’ ability to offer the drug, restricted women’s access to receive it, and the potential of the medication would never have been realized,” says Saporta.
Physicians without surgical skills will still be able to prescribe the drug, provided they have a backup who can provide surgical intervention in cases of incomplete abortion or severe bleeding, a rare occurrence in 1 percent of the drug’s users.
The drug could be available by November, probably at a cost of $300 to $550, roughly equivalent to the cost of surgical abortion.
Physicians will need to contact Danco for a supply and assert to the firm they have the necessary qualifications. The drug will only be available at the doctor’s office, rather than from a pharmacy. The combination of pills is expected to induce one third of all future abortions in the United States, with the remainder still performed surgically.
The National Abortion Federation has set up a hotline at 800-772-9100 that will refer women to providers who will be offering the pill. Danco Labs also suggests women check with Planned Parenthood and the National Coalition of Abortion Providers to find out which doctors will be offering the medication.
A recent survey by the Kaiser Family Foundation, a Menlo Park, Calif.-based health policy group, reported that many doctors who don’t perform surgical abortions said they would consider prescribing Mifeprex.
Although only a quarter of gynecologists currently perform abortions, 44 percent of those surveyed said they were somewhat likely to prescribe RU-486 once it becomes available.
While only five percent of family physicians currently perform abortions, 31 percent said they would offer the drug.
“I think this will bring the issue more front and center for many of us that have not had to deal with that,” says Dr. Richard Roberts, president of the American Academy of Family Physicians.
The traditional abortion clinic is hardly expected to go the way of the dinosaurs just yet — RU-486 will only be approved for use within the seven weeks after a woman’s last period. Any time after that, she will still need to rely on a traditional surgical abortion.
“This is the first major technological difference since the 1960s,” saysDr. Eric Schaff of the University of Rochester, the coordinating investigator of the ongoing RU-486 clinical trials in the United States. “It could make abortion earlier, private, and accessible by primary-care providers.”
The Associated Press contributed to this report.