FDA Gets Closer to Approving RU-486 Pill for Use in U.S.
The French abortion pill, subject of a decade-long battle to enter the United States, moved a step closer to the U.S. market Friday.
The Food and Drug Administration said that unspecified “questions need to be resolved before final marketing approval can be granted.”
The pill, known as RU-486, or mifepristone, induces an abortion when administered early in pregnancy with another drug, misoprostol.
“We still have additional issues to resolve,” said Sandra Waldman, a spokeswoman for the Population Council, adding, “Eventually we’ll have it.”
Sandra Jordan, a spokeswoman for Planned Parenthood, said, “We’re disappointed that the FDA hasn’t approved the drug outright, but we’re optimistic because we think they are committed to approving it.”
Abortion opponents, meanwhile, said they hope the FDA will decide against approving mifepristone.
The process of finding and approving a manufacturer has been difficult.
The French company that developed the drug in the 1980s refused to distribute it in the United States because of boycott fears, and no American pharmaceutical company would manufacture it either.
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