RU486: At Last, Hope for Progress

It is welcome news indeed that the French maker of RU486, the so-called abortion pill, at long last appears ready, however nervously, to brave the political waters here. The president of Roussel-Uclaf last week told the Food and Drug Administration that the company believes the drug should be made available in the United States.

Before RU486 may be sold here, the FDA must approve a “new drug application,” which includes data from clinical trials as well as information about the drug’s manufacture.

Roussel-Uclaf had long been unwilling to provide drug samples for the necessary FDA testing, fearing anti-abortion groups would launch boycotts of other products of its German parent firm, Hoechst AG. Repeated entreaties from health care and women’s advocates--including visits by U.S. delegations to Frankfurt and Paris--were to no avail.

Roussel clearly is responding to encouraging signals from the Clinton White House. Last month, President Clinton ended a decade of abortion-related bans and ordered review of the FDA’s prohibition on the importation of RU486. The drug, used in France, Britain and Sweden, appears to be safer than a traditional surgical abortion.

A skittish Roussel prefers not to market the drug directly but rather to make it available through a U.S. pharmaceutical firm or research center. In any event, the mechanism by which the drug can be evaluated by the FDA on its merits is not as important as the fact that this review now appears more likely.