Firm Backs Out of U.S. Abortion-Pill Project

The European company that had agreed to manufacture the French abortion pill for sale in the United States is backing out of the project, according to a source knowledgeable about the situation. The decision may delay the drug’s introduction here.

The U.S. sponsor of the pill, the nonprofit Population Council, now must try to find a replacement manufacturer.

Sandra Waldman, a spokeswoman for the New York-based council, on Tuesday declined to confirm that the European company is backing out, but said, “What we want to say is that there’s a dispute [with the manufacturer] and we’re continuing to talk to them, and our commercial partners are very actively looking for other manufacturers.”

Waldman said she did not know why the European partner would not want to produce the pill. Asked if the setback would delay the pill’s availability, Waldman replied, “We don’t know whether it will or how much it will, if at all.”

The abortion pill, also known as RU-486, has been available for several years in Europe. But it has been controversial in the United States, where it is opposed by anti-abortion groups.

Fearful of economic boycotts or violent protests, no major U.S. pharmaceutical company has been willing to market the drug here. The European manufacturer has never been identified publicly by the council, because of concerns about a backlash against it by abortion foes in this country.

An attorney for the Population Council, James Boynton, did not deny that the manufacturer was backing out of its agreement with the council. “Let’s just say we have a dispute,” he said.

The council and the foreign drug company have “been in negotiations” for several weeks, Boynton said. “And we continue to be in negotiations.”

Boynton said the council has not decided whether to pursue legal action against the drug company over the dispute.

Brian M. Freeman, a New York investor in the project, did not return phone calls Tuesday seeking comment on the manufacturer’s decision to drop out.

The council, which promotes family planning and contraception, decided to push ahead with plans to market RU-486, whose technical name is mifepristone, after the French developer of the drug gave its U.S. patent rights to the council in 1994. Because the council is primarily a research organization and not a business, it reached licensing agreements with business executives to set up networks for marketing and distributing the pill.

Mifepristone is a synthetic steroid that makes it difficult for a fertilized egg to adhere to the lining of the uterus. When taken with misoprostol, a drug that triggers uterine contractions, the result is an abortion.

Mifepristone offers women an alternative to surgical abortion and therefore its use is sometimes called a “medical abortion.” Unlike surgical abortions, it is effective in producing abortions in the early weeks of pregnancy. The side effects, most of which are caused by the second drug, misoprostol, include bleeding, cramps, nausea and vomiting.

Last fall, the Food and Drug Administration conditionally approved the pill’s use, declaring it “safe and effective.”