Abortion Pill Clears Hurdle Toward U.S. Sale
Breaking a longstanding impasse over whether the controversial abortion pill RU-486 will ever 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 in this country, the Food and Drug Administration announced Tuesday.
The agreement between the pill maker, Roussel-Uclaf, and the Population Council will enable the U.S. organization to find a manufacturer in this country 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.”
Catley-Carlson and FDA Commissioner David A. Kessler acknowledged, however, that the sale of the pill in the United States 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 is opposed by anti-abortion organizations.
Abortion foes have threatened to boycott businesses owned by Hoechst AG, the German parent company of Roussel-Uclaf, if the pill is allowed into this country. 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% effective in ending a pregnancy.
Douglas Johnson, legislative director of the National Right to Life Committee, reacted angrily to Tuesday’s announcement.
“The pro-life movement in America will hold Hoechst 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. Hoechst and Roussel don’t get off the hook simply by using a surrogate or a proxy.”
The Hoechst AG subsidiaries that operate in the United States include Hoechst-Celanese Corp., a drug manufacturer.
RU-486 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 former Presidents Ronald Reagan and George Bush.
But President Clinton, who campaigned as an abortion-rights candidate, repeatedly has said he believes that 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 after a meeting Tuesday at FDA headquarters in Rockville, Md., between Catley-Carlson and Edouard Sakiz, president of Roussel-Uclaf.
“With the encouragement of the U.S. government, Roussel-Uclaf today agreed to license the drug RU-486 to the Population Council for distribution in the United States,” the FDA said in a written statement.
“This agreement is based on a 1982 contract between Roussel and the Population Council,” the statement continued. “Hoechst-Roussel/Uclaf is not willing to be involved in the distribution or production of RU-486 in the United States. Roussel-Uclaf has agreed to transfer the technology necessary for producing the drug to the Population Council as contemplated in the 1982 contract.”
As a result of the move, the Population Council can submit an application to the FDA for approval of the drug, even though--as a scientific and research organization--it will not actually manufacture or distribute it. The Population Council served a similar role in the approval of Norplant, a surgically implanted contraceptive for women.
