FDA Panel Finds Mifepristone Safe, Effective
Final Decision on "French Abortion Pill"
to be Made by Mid-September
by Jennifer Jackman
The Food and Drug Administration (FDA) Committee on Reproductive Health Drugs has recommended that the FDA approve mifepristone (formerly known as RU 486) for use in the United States for early abortion. The Committee, after reviewing the Population Council’s New Drug Application and hearing eight hours of testimony on July 19, determined that mifepristone is safe and effective, and voted 7-0 in support of a final recommendation that mifepristone’s availability in the U.S. will benefit women. The Committee’s recommendation represents a milestone that could result in FDA approval of the compound by mid-September.
"The FDA Committee’s recommendation is a giant step forward in making this medical breakthrough available to women in the United States," said Eleanor Smeal, President of the Feminist Majority Foundation, which has led an eight-year campaign to bring mifepristone to the United States. "The time for approval of mifepristone is now — and long overdue. Every day that mifepristone is not available to American women is another day that some woman will suffer needlessly. And, equally important, every day mifepristone is not available is another day that scientific development of anti-progestins for a number of serious diseases and conditions primarily affecting women will be delayed."
The FDA has classified mifepristone as a "priority application" since it is the first medical abortion procedure to receive FDA consideration. According to FDA Commissioner Dr. David Kessler, this makes approval in six months possible. The Population Council filed its New Drug Application in March 1996. The FDA expects to issue a decision on the mifepristone application in mid-September. At that time, the FDA could approve mifepristone for marketing, determine that the compound is approvable, or disapprove this method of medical abortion.
The Population Council is seeking approval of the combination of mifepristone and misoprostol, a prostaglandin, for use up to 49 days of pregnancy. Advances in New Technology is the non-profit organization licensed by the Population Council to arrange for manufacture and distribution of the compound.
The day-long hearing, which was held at an unmarked FDA facility with extensive security in Gaithersburg, Maryland, included presentations by the Population Council and clinicians on the French and American data submitted as a part of the FDA application. The data showed that a regimen of mifepristone in combination with misoprostol, a prostaglandin, produced a 95.5% efficacy rate. Women in both France and the U.S. were pleased with the procedure, and most preferred it to surgical abortion and would recommend it to a friend.
The scientific presentations were followed by two hours of public testimony with proponents outnumbering opponents by 2-1. Over 20 women’s and scientific organizations, including the Feminist Majority Foundation, American Medical Students Association, American Public Health Association, National Women’s Health Network, American College of Obstetricians and Gynecologists, and the National Organization for Women, testified in favor of mifepristone approval. Physicians and patients who participated in the recent U.S. mifepristone clinical trials also testified in support of the procedure.
Susan Hill, President of the National Women’s Health Organization, which manages abortion clinics in eight states, testified about the importance of mifepristone to ending anti-abortion violence. By increasing the number of physicians who perform abortions and decentralizing the provision of abortion services, Hill believes the availability of mifepristone will "stop the ghettoization of abortion providers."
The Family Research Council, Life Issues Institute, and Pharmacists for Life International were among the ten anti-abortion organizations and individuals who voiced opposition to mifepristone approval in the public session.
In the days following the hearing, the New York Times, Washington Post, and L.A.Times editorialized in support of the FDA Committee’s recommendation for approval of mifepristone. | 
