FDA close to approving nonsurgical abortion drug
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
"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
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
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
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
"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
Correspondent Jeff Levine contributed to this report.
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