Lawsuit may delay RU-486 debut in U.S.

The U.S. debut of RU-486 (mifepristone) may be delayed by legal disputes, but family planning officials are making every effort to keep the project on track.

"It’s not going backward, and we can’t even say at this time that [these disputes] will postpone availability in the United States," says Sandra Waldman, spokeswoman for the New York City-based Population Council. "We’ve been saying all along that the drug would be available in the latter part of 1997, so that’s still doable."

The Population Council, a nonprofit research organization and owner of the U.S. drug manufacturing rights, has joined with Advances in Health Technology, a Washington-DC nonprofit organization also involved in the American RU-486 effort, in filing suit against Joseph D. Pike. Pike, a San Diego businessman, was chosen by the Population Council to raise money to manufacture and distribute the drug. The lawsuit, filed in November in New York State Supreme Court, charges Pike with fraud. The suit seeks to have Pike’s interest in the drug transferred to a receiver so it can be sold.

According to Population Council officials, Pike had been asked in July to divest his financial interest in the drug, which had been sublicensed to him. This action was taken after the council learned Pike had been disbarred for forgery in a 1985 North Carolina real estate deal and given a two-year suspended sentence. When Pike failed to meet a Nov. 1 deadline to release his interest, the lawsuit was put into motion.

The abortion drug regimen already has made two important steps toward availability with the issuance of an "approvable" letter by the Food and Drug Administration (FDA), which means the agency does not have enough information to make an approval, and the regulatory agency’s determination that clinical data demonstrate the drug’s safety and efficacy. (See Contraceptive Technology Update, November 1996, p. 141, for more information on the FDA’s action. Also use the patient handout on mifepristone inserted in this issue to help educate patients on the new drug.)

"This does not affect our filing [with the FDA] or our approvable letter or anything like that," Waldman says. "It doesn’t affect our manufacturer, our basic source of supply. This is mainly to do with the distribution and marketing."