At long last, the U.S. Food and Drug Administration will review an application to market RU 486 (mifepristone) in the United States. The Population Council submitted a new drug application for mifepristone to the FDA in March, and announced that legal rights to arrange the manufacture and distribute the drug have been awarded to Advances in Health Technology, a newly formed group headed by Dr. Susan Allen.
"Submission of an FDA application is a long-awaited milestone in our eight year campaign to license mifepristone in the United States. The day is finally approaching when the women of this nation will join the women of France, Great Britain, Sweden and China in having access to this medical breakthrough," said Eleanor Smeal, President of the Feminist Majority Foundation.
FDA approval for mifepristone could take between six months and a year. The compound's extensive record of safety and efficacy in Europe, where it has been used by over 150,000 women, could expedite the approval process.
Women may have access to an American-made version of RU 486 while final FDA approval is pending. Abortion Rights Mobilization (ARM) leader Larry Lader has announced that his organization will sponsor clinical trials using an RU 486 copy at three sites across the country involving 2,000 women. Trials are slated to begin following FDA sanction of the clinical protocol. ARM has no plans to market the drug.
As FDA approval of mifepristone nears, another form of medical abortion is gaining increased attention. Clinical trials have found that methotrexate, a drug currently used to treat cancer and arthritis, is effective as an early medical abortion procedure. Methotrexate, like mifepristone, is used in conjunction with Cytotec, a prostaglandin that induces uterine contractions.
New trials using methotrexate in pill form are now underway at the University of California, San Francisco. Conducted by Dr. Philip Darney, the trials administer to 75 women who are less than seven weeks pregnant four pills (50 mg.) of methotrexate. The women also will be given four Cytotec pills to be inserted as a vaginal suppository one week later.
At their national convention in March, the National Abortion Federation encouraged use of methotrexate and announced that clinical guidelines for administering the drug as a method of abortion would soon be issued to member clinics.
