RU-486 on track for U.S. distribution

With the settlement of a legal dispute and the formation of a new company, officials with the New York City-based Population Council say everything is on track for regulatory approval and distribution of RU-486 (mifepristone) to American clinicians by the end of 1997.

Newly formed Advances for Choice, based in New York City and headed by veteran pharmaceutical industry executive Jack Van Hulst, now has responsibility for the distribution of mifepristone for use in early medical abortion, according to a statement issued by the Population Council. The new company also is authorized to develop other avenues for the drug’s use.

Advances for Choice will assume the duties of coordinating educational campaigns for clinicians and consumers, a function originally designated to the Washington, DC-based Advances in Health Care Technology. Members of the nonprofit organization will continue to be involved in the effort through their service on the Advances for Choice advisory board, say council officials.

The Population Council continues to hold the U.S. patent rights to the drug, says spokeswoman Sandra Waldman. The council is working with Advances for Choice in obtaining the necessary manufacturing and labeling information requested by the Food and Drug Administration for final approval of the drug. After clearing the regulatory hurdles, the drug should be available to physicians by the end of the year, council officials say.

The establishment of the new company comes on the heels of a legal settlement between the Population Council and Advances in Health Technology against San Diego, CA, businessman Joseph Pike. Originally named by the council to raise funding and arrange for the manufacture and distribution of the drug, Pike was asked to relinquish his interests following the revelation of a forgery conviction in connection with a North Carolina real estate deal. When he failed to do so, the two groups filed a lawsuit seeking transfer of Pike’s financial interests in the drug. (For details of the lawsuit, see Contraceptive Technology Update, January 1997, p. 11.)

Under the settlement’s terms, Pike is no longer involved in any aspect of management in the new company. He maintains a small but passive, interest and has sold the majority of his equity interest to the existing investor group.