A Forward Move for RU-486 : Promising talks on U.S. importation of abortifacient are now under way

The process by which new prescription drugs are licensed for use and sale in this country has come under increasing criticism, in large measure because many people believe it takes too long. However, in the case of the drug RU-486, the length of that process has had little to do with the U.S. Food and Drug Administration’s formal testing and licensing procedures and everything to do with politics.

RU-486 has been the subject of intense debate since it was legalized for use as an abortifacient in France in 1988. The so-called abortion pill, commonly taken in conjunction with a second hormone, is now used legally in four countries. One of the four, Britain, last month agreed to allow Americans and other foreigners to obtain the drug there for a $500 fee.

Testing in Europe has found RU-486 to be 96% effective in terminating a pregnancy and to cause fewer side effects and complications than the traditional surgical abortion. But precisely because RU-486 appears to be medically less risky than a surgical abortion, as well as quicker and more private, abortion opponents have acted--successfully, so far--to block its testing and introduction in the United States. Groups contending that the pill would encourage abortion have intimidated the drug’s skittish European manufacturer, Roussel Uclaf, by threatening to organize consumer boycotts of its other products if it made RU-486 available for testing in the United States.

Now, the Population Council, a New York-based nonprofit group devoted to improving access to birth control, is negotiating with the French pharmaceutical maker to provide the drug for formal testing by the FDA and eventual distribution in this country. That formal process could take one to three years.

That Roussel Uclaf is talking about U.S. distribution is certainly welcome news. The negotiations have the support of the Clinton Administration, and early indications are that they will be successful. If they are, RU-486 could redefine the politics of abortion and make the confrontations at clinics obsolete.