091996 FDA to Approve Abortion Pill,
But Seeks Labeling Information

By LAURIE MCGINLEY
Staff Reporter of THE WALL STREET JOURNAL

WASHINGTON -- The Food and Drug Administration said that the French abortion pill, RU-486, is safe and effective in ending pregnancies early and that it stands ready to approve the drug, once it gets more information about how it will be manufactured and labeled.

The FDA decision on the emotionally charged issue drew an immediate denunciation from the antiabortion group Operation Rescue. "RU-486 has only one purpose: to kill," the group said in a statement. But supporters of the drug applauded the FDA move, saying it's important to make safe, nonsurgical abortion procedures available for women who wish to end pregnancies.

The FDA action came in the form of an "approvable letter" it sent Wednesday to the Population Council, a New York-based nonprofit group that holds the U.S. patent rights to the drug, called mifepristone. The FDA said it has determined "that the submitted clinical data demonstrate the safety and efficacy of mifepristone" when used "under close medical supervision" in combination with another drug called misoprostol, for terminating pregnancies early.

Several years ago, the manufacturer of RU-486, Roussel-Uclaf, decided that it wouldn't market the drug in the U.S. out of fear of becoming a target of abortion protests. Two years ago, it donated the U.S. rights to the Population Council. The nonprofit group won't release the name of the U.S. manufacturer because of security concerns.

The FDA declined to detail the kind of additional data it's seeking from the council, saying such information is proprietary. It told the council that the information must be submitted before a final approval for marketing can be granted. But the issuance Wednesday of the approvable letter makes it all but certain the agency will approve the drug soon.

An FDA advisory committee recommended on July 19 that the agency approve the drug, and FDA Commissioner David Kessler said at the time that he would make a decision by Sept. 18. The Population Council's 164-volume marketing application was submitted to the agency in March.

In a statement, the Population Council said the FDA action "marks another major step in the long and complex process to make mifepristone available to American women as it is to women in other countries." It added, "We are sure we will be able to provide the FDA the outstanding information necessary for approval." The drug is available in several countries, including France, China and the United Kingdom.

The drug-induced abortion procedure requires three visits to the doctor. The Population Council has said mifepristone would be available only through health-care providers.