RU-486 Slated for Approval by Year's End, Sources Say
WebMD News Archive
Nov. 18, 1999 (Chicago) -- Sources at a scientific meeting here tell WebMD that mifepristone, the abortion drug known as RU-486, will be approved for use in the U.S. before the end of the year. The FDA granted mifepristone an "approvable" letter in 1996, pending the resolution of certain manufacturing issues. Abortion foes have tried to keep the drug off the market.
The Population Council, which holds the rights to make and market mifepristone in the U.S., confirms that the approval of RU-486 is imminent. Christina Horzepa, public information specialist for the organization, tells WebMD that the FDA has been working with the Danco Group of New York on production and distribution issues associated with the controversial product. Danco is the licensee designated by the Population Council to manufacture RU-486.
RU-486 is available in Europe, but an FDA spokesman declined to comment on reports about the pending approval. Mifepristone is taken early in pregnancy then followed by the companion drug misoprostol two days later. That combination triggers a chemical abortion.
Advocates say mifepristone will allow women to have abortions safely and in private without having to face possible harassment by opponents of the procedure at an abortion clinic. Still, under the current protocol, a woman using RU-486 would have to visit the doctor three times during the procedure. The drug won't be available at pharmacies, but only from physician providers.
However, research presented here at the 127th Annual Meeting of the American Public Health Association suggests that women might be able to take RU-486 without a doctor's supervision. Reviewing the data from a trial of more than 2,000 U.S. women who used mifepristone, demographer Cynthia Harper, PhD of the University of California, San Francisco, says home use could be possible.
"The most simple it could get is that women would be in charge of it, and probably the most supervised it could get is the regimen that was followed in this trial," Harper tells WebMD. Among the issues, says Harper, is how quickly women could determine they were pregnant since delays were associated with more side effects. Patients would also have to cope with the expulsion of the embryo on their own.