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— The Food and Drug Administration today approved the early abortion pill known as RU-486, or Mifeprex, with few restrictions, possibly changing the course of abortion history in the United States.
“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 pill, mifepristone, is taken within seven weeks of a woman’s last period, followed by a second drug, misoprostol, which causes the pregnancy to be expelled. A follow-up visit to the physician will be required within 14 days to determine the pregnancy has been terminated. When taken this way, the drug has been shown to have a 95 percent success rate. Women will also receive a guide explaining how to take the drug. Because the pill drops off in effectiveness after 49 days, the pill is approved for use by doctors who have some experience in accurately dating a pregnancy. However, more stringent restrictions that had been anticipated were not put into place.
Any physician will be able to prescribe the drug, provided he or she has a backup who can provide surgical intervention in cases of incomplete abortion or severe bleeding, a rare occurrence. Typically, a woman will have bleeding and spotting for around nine to 16 days. In 1 percent of cases, bleeding is so severe it requires surgical intervention.
Change Abortion Location
This unlimited FDA approval is expected to bring the drug out of abortion clinics and into the offices of family physicians. “This is a medical milestone,” says Vicki Saporta, a spokeswoman for the Washington, D.C.-based National Abortion Federation, which accredits abortion providers.
The drug could be available as early as November, probably at a cost of $300 to $550, equivalent to the cost of surgical abortion. In its last action on the drug in February, the FDA notified Danco Laboratories of New York City, the company producing the pill in the United States, that approval was pending a few final questions. The company set Sept. 30 as a deadline for action. The drug has been approved since 1988 in France and expanded widely across Europe, where more than 620,000 women have used it, but its approval stalled in the United States amidst the contentious politics of abortion. The FDA deemed the drug safe and effective in 1996, but since then has only approved the drug for clinical use by 7,000 women at designated sites. The FDA will also require the Population Council, which controls the U.S. patent rights, to sponsor additional post-marketing trials of the drug tracking patient outcome and compliance with signing consent forms.
Few Restrictions
However, the restrictions that abortion-rights activists most feared, such as requiring doctors to be to be surgical abortion practitioners, or within an hour of an emergency room, were not put in place. “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,” Saporta says. However, she adds, 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,” says Dr. Eric Schaff of the University of Rochester, the coordinating investigator of RU-486 in the United States. “It could make abortion earlier, private, and accessible by primary- care providers.”
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