Maker of controversial abortion pill RU-486 agrees to distribution in U.S.

April 21, 1993|By Los Angeles Times

WASHINGTON -- Breaking a long-standing impasse over whether the controversial abortion pill RU-486 ever will be available in the United States, its French manufacturer has agreed to license the drug to a New York-based scientific research organization for eventual distribution here, the Food and Drug Administration has announced.

The agreement between the pill-maker, Roussel-Uclaf, and the Population Council will enable the U.S. organization to find a manufacturer in the United States willing to conduct clinical trials of the drug that are likely to lead to FDA marketing approval for the pill.

"What we will do is identify a manufacturer for RU-486 in the United States market, and will also begin clinical trials to test the drug in the United States," said Margaret Catley-Carlson, president of the Population Council. "We're going to move as quickly as possible."

Both Ms. Catley-Carlson and FDA Commissioner David A. Kessler acknowledged yesterday, however, that the sale of the pill in the U.S. is probably several years away.

RU-486 -- which chemically induces abortion -- has been the focus of intense international debate. Access to it in the United States has long been sought by family planning organizations and women's groups but opposed by anti-abortion organizations.

Abortion foes have threatened to boycott businesses owned by Hoeschst AG, the German parent company of Roussel-Uclaf, if the pill is allowed into the United States. It already is marketed in France, Britain and Sweden, where an estimated 120,000 women are believed to have used it. It is considered 96 percent effective in ending a pregnancy.

Douglas Johnson, legislative director of the National Right to Life Committee, reacted angrily to yesterday's announcement.

"The pro-life movement in America will hold Hoeschst and Roussel responsible if any entity applies for a license to market RU-486 for abortion," he said. "What I mean by this is potential product boycotts and the like. Hoeschst and Roussel don't get off the hook simply by using a surrogate or a proxy."

The drug works by inducing the uterus to shed its lining and expel the developing embryo. It is taken along with another hormone, prostaglandin, which induces contractions.

Until now, Roussel-Uclaf had been reluctant to seek access to the U.S. market because of the anti-abortion sentiment expressed by the Republican administrations of Presidents Reagan and Bush.

But President Clinton, who campaigned as a "pro-choice" candidate, has said repeatedly that he believes women should have access to RU-486. Shortly after taking office, he repeated that contention as he lifted several abortion-related bans that had been imposed by the two Republican administrations.

The agreement was announced following a meeting yesterday at FDA headquarters in Rockville, Md., between Ms. Catley-Carlson and Edourd Sakiz, president of Roussel-Uclaf.

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