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FDA close to approving nonsurgical abortion drug

ru 486 September 18, 1996
Web posted at: 7:30 p.m. EDT

WASHINGTON (CNN) -- Federal regulators said Wednesday they will approve the nonsurgical abortion drug RU 486, pending the receipt and review of information about its labeling and manufacturing.

The Food and Drug Administration said the drug appeared safe and effective when used under close medical supervision. The FDA issued an "approvable letter," which indicates the major issues have been resolved.

"I would certainly view the approval of this drug as a tremendous advance for women in this country," said Dr. Susan Allen, of the nonprofit Advances in Health Technology.


Allen's group would distribute the drug in the U.S., possibly as early as next year. The drug RU 486 will not be available at pharmacies, but only through a doctor's office.

The drug has already been approved in France, Britain and Sweden, and has been used by about 200,000 women to terminate pregnancy. Use of the drug requires a combination of pills and three trips to a doctor.

The Population Council, which holds the legal rights to the drug in the U.S., said it was delighted with the FDA's conditional approval.

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"We are sure we will be able to provide the FDA the outstanding information necessary for approval," the council said in a statement.


Sources had speculated a possible obstacle to the drug's approval would be the inspection of the European manufacturing plant. The facility's location has been kept secret to avoid possible reprisals directed against the pharmaceutical company by abortion opponents.

Getting speedy FDA consideration of the drug has been a priority of the Clinton administration, but abortion opponents have fought to keep it out of the United States. They say it would make abortions too easily available.

"The only interest they have is to increase abortions in America, and to further their own radical, extremist agenda," said Olivia Gans, of the National Right to Life Committee.

An advisory panel to the FDA recommended approval of the drug in July. The agency generally follows panel recommendations.

Correspondent Jeff Levine contributed to this report.

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