
                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: TUESDAY, May 17, 1994                   TAG: 9405170128
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A1   EDITION: METRO 
SOURCE: Associated Press
DATELINE: WASHINGTON                                LENGTH: Medium

U.S. TO TEST ABORTION PILL RU-486

The abortion drug RU-486 could be licensed for use in the United States within two years, because of an agreement announced Monday that gives French drug patents to an international research agency.

France's Roussel Uclaf agreed to donate its patents on RU-486 to the Population Council, a non-profit organization that will test the drug on 2,000 American women this fall.

``American women who waited far too long for this drug will now see the days of stalling and foot-dragging are over,'' said Rep. Ron Wyden, D-Ore., who has spent four years pushing for the drug's availability here.

But abortion opponents decried the agreement, questioning whether RU-486 is a safer alternative to surgical abortions.

Rep. Christopher Smith, R-N.J., warned that women injured by RU-486 may have no financial recourse from a non-profit agency. ``That should be a red flag to any woman who thinks this newest form of baby poisoning is safe,'' he said.

Federal health officials say RU-486 won't be an over-the-counter remedy, and can be given only by specially trained doctors with quick access to hospitals in case of complications.

``Women should not think that pregnancy termination using a medical regimen will be simple. It will not be,'' said Food and Drug Administration Commissioner David Kessler.

Although the FDA is expected to approve the drug, based partly on records of its use on 150,000 European women, Kessler said he won't rubber-stamp it.

RU-486 blocks development of progesterone, a natural steroid hormone that is essential for maintaining pregnancy. A doctor gives the pill and two days later gives the woman a dose of prostaglandin, a hormone that causes contractions to expel the embryo.

Monday's agreement was reached after 13 months of negotiations. Attorney Lester Hyman said Roussel Uclaf donated the drug, rather than selling it here, because of its ``sensitive nature'' and President Clinton's push for it.

The Population Council will choose a company to make and distribute the drug here. That process and the clinical trial should take about 14 months. FDA review will take an additional six months, Kessler said.

by CNB