Dispute snags American mifepristone debut
American women continue to wait for the introduction of mifepristone (RU-486) as negotiations proceed toward a secure manufacturing source for the drug.
The Population Council in New York City, which holds mifepristone’s U.S. patent rights, is continuing to talk with an unnamed manufacturer, despite a report in the Washington Post that such discussions were called off after an agreement had been reached between the two organizations.1
"There is a dispute with the manufacturer we had contracted with to provide mifepristone, but we still are negotiating with the company," says Population Council spokeswoman Sandra Waldman. "At the same time, our distributor partner is looking for other manufacturers, should they be necessary."
The Population Council had believed that its February 1997 distribution partnership with New York City-based Advances for Choices would clear the final obstacle toward mifepristone’s United States debut. The process had been slowed with controversy surrounding San Diego, CA, businessman Joseph Pike, originally appointed by the council to raise funding and arrange for the drug’s manufacture and distribution. The council filed a lawsuit against Pike to get him to relinquish his interest in the project after it was revealed he held a previous forgery conviction.
The lawsuit was settled prior to Advances’ announcement as the Population Council’s new partner. (See Contraceptive Technology Update, April 1997, p. 51, for information on the partnership, and CTU, January 1997, p. 11, for details on the lawsuit.)
Although the Population Council had projected completion of all manufacturing, distribution, and regulatory processes by the end of 1997, status of the project may be hampered by the recent turn of events.
"The dispute undoubtedly will delay things, but it is still too early to say how much," says Waldman.
1. Murphy C. Abortion pill dispute may delay debut: U.S. sponsor losing European supplier. Washington Post, June 11, 1997:A01.