FOR IMMEDIATE RELEASE
Thursday, September 28, 2000
NEW YORK--The Food and Drug Administration's approval today of mifepristone, a safe and effective early-option abortion pill, is a victory for American women, the American Civil Liberties Union said today.
"The approval of this drug represents a breakthrough in reproductive health care in the United States," said Catherine Weiss, director of the national ACLU's Reproductive Freedom Project. "Mifepristone has great promise. Most significantly, it should give women who live far from an abortion provider better access to a safe, private, and early option for ending unwanted pregnancies."
Mifepristone can be used up to the 49th day (or 7th week) of pregnancy. Under the approved regimen, women first obtain mifepristone from their physician and return two days later to take a second drug, misoprostol.
In the last decade, more than half a million women in Europe have safely used this drug combination as have thousands of American women in clinical trials. In 1996, the FDA declared mifepristone safe and effective for use as an early method of abortion, though it did not issue final approval of the drug until today.
Despite indications earlier this year that the FDA would release the drug with numerous restrictions, many of which would have limited the efficacy of this drug, today's approval was not subject to these terms.
"A high hurdle was crossed today when the FDA approved the drug," said Weiss, "but we will undoubtedly face new ones as mifepristone reaches the market. We stand ready to help health providers with any legal problems that may arise as they begin to treat patients with this important new drug."
Under the terms of the approval, mifepristone must be provided by or under the supervision of a physician who can determine the duration of a woman's pregnancy; detect an ectopic pregnancy; and provide or have made arrangements for other qualified practitioners to provide surgical intervention in the rare cases where it might be necessary. In addition, the approved labeling for the drug stipulates that the second drug, misoprostol, should be administered in a physician's office.