WASHINGTON -- The French company that makes the abortion pill RU-486 has agreed to license the drug to a U.S. contraceptive research group so it can find a manufacturer in the United States, the commissioner of the Food and Drug Administration said yesterday.
The commissioner, Dr. David Kessler, said that after a meeting yesterday in Rockville, Md., Edouard Sakiz, president of the French company, Roussel-Uclaf, agreed to license the drug and the technology to make it to the Population Council, a not-for-profit research organization based in New York City.
Margaret Catley-Carlson, president of the council, said her organization would find a manufacturer in the United States and sponsor an application to the Food and Drug Administration for approval to market the drug.
The Population Council, created in 1952 by John D. Rockefeller III and known for developing contraceptives and family planning for the developing world, will also sponsor a clinical trial for the abortion pill that will involve least 2,000 U.S. women, she said.
With the work needed to complete the trial, find a capable manufacturer and satisfy the drug agency's requirements for approval, Ms. Catley-Carlson said it could be "a couple of years" before RU-486 becomes widely available in the United States.
Dr. Kessler said Roussel had also agreed to provide the agency with its toxicology and chemistry data on the drug soon.