RU-486: LEGAL OBSTACLE TO U.S. DISTRIBUTION SETTLED
"A legal dispute that threatened to delay U.S. introductionThis is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
of the abortion pill RU-486 has been resolved," USA TODAY reports
(Painter, 2/13). The settlement agreement "ends a dispute
between the Population Council and California businessman Joseph
Pike over control of selling the pill" (see AHL 11/5/96). The
council, a nonprofit family planning organization, which holds
rights to the pill, "contracted with Pike in 1995 to set up
networks for marketing and distributing the drug." The council
has now established a new company, Advances for Choice, to
distribute the drug. Jack Van Hulst, president and CEO of
Advances, "said that the project has enough money to bring the
drug to market." WASHINGTON POST reports that the sales of RU-
486 in the U.S. are expected reach about $100 million annually
(Murphy, 2/13).
ON TRACK: Van Hulst said that Advances will submit all the
necessary materials for FDA approval by July. He said that the
drug should be approved and available to physicians by the end of
the year. NEW YORK TIMES reports that last September, the FDA
said RU-486 "was approvable as a safe and effective way to end
pregnancies up to seven weeks." However, the FDA asked for
"further information on manufacturing and labeling" (Lewin,
2/13).