Roanoke Times Copyright (c) 1995, Landmark Communications, Inc. DATE: MONDAY, May 16, 1994 TAG: 9405160053 SECTION: NATIONAL/INTERNATIONAL PAGE: A1 EDITION: METRO NOTE: BELOW SOURCE: Chicago Tribune DATELINE: WASHINGTON LENGTH: Medium
One of President Clinton's first acts was to move to lift the U.S. ban on the French-invented drug, which serves as a licensed alternative to surgical abortion in Britain, France and Sweden.
On day three of his presidency, declaring that RU-486 no longer would be "held hostage to politics," Clinton ordered Secretary of Health and Human Services Donna Shalala to get RU-486 licensed and manufactured in this country as quickly as possible.
After 13 months of negotiations, however, the administration's efforts have been stymied by AG Hoechst of Germany, owner of the French company Roussel Uclaf that holds the patent on the drug.
Hoechst, a publicly traded company, is resisting efforts to introduce RU-486 here, apparently out of concern that anti-abortion forces would wage a boycott against its products, which include textiles, rug fibers and drugs for diabetics and heart patients. Hoechst subsidiaries have annual U.S. sales of $7 billion.
In April 1993, Roussel Uclaf raised hopes that RU-486 quickly would be made available in the United States when it agreed to transfer its patent on the drug to the Population Council, a non-profit research organization in New York.
The council, in turn, pledged to find a domestic manufacturer to produce RU-486 and to conduct the clinical trials necessary to get Food and Drug Administration approval to sell it here.
But since then, observers of the discussions said, Hoechst has raised obstacle after obstacle in negotiations toward a formal agreement with the Population Council, seeking unusually broad assurances that it would be protected from potential product liability suits or losses from anti-abortion protests.
Department of Health and Human Services officials, while not directly involved in the discussions, have attempted from the sidelines to prod them along, with little success.
"It's outrageous," said Rep. Ron Wyden, D-Ore., who has accused Hoechst of foot-dragging. Wyden has scheduled a hearing before a congressional subcommittee today to investigate the delays.
Supporters of the drug were hoping last week that the threat of tough questioning by Congress would prompt Hoechst officials toward a quick resolution. Lawyers for Hoechst and the Population Council were expected to negotiate through the weekend.
by CNB