RU486: A Changing Tune at the FDA : ‘Abortion pill’ maker should now seek federal approval

Even though Bill Clinton will not assume the presidency for a month, already--fortunately--the Food and Drug Administration appears to have changed its tune on the drug RU486, an abortifacient that has become a bitter symbol in the abortion rights debate. The FDA has long raised concerns about the drug’s safety and use. Since 1989, RU486 has been the subject of an FDA-imposed “import alert,” allowing officials to seize any quantity of the drug discovered at U.S. ports of entry. This despite its apparently safe use by more than 100,000 women in France and other European countries.

Now, in a letter sent to Rep. Ron Wyden (D-Ore.) last week, the FDA says that European clinical trials of RU486 “may well be sufficient” to merit approval. Moreover, the review process could take just “four to six months” and the cost “should not be excessive because much of the necessary information is already available,” the letter says.

This seeming change of heart by the FDA is most welcome because concerns about RU486’s safety were never the primary reason it has not been approved for use in the United States. RU486 has shown great promise in treating some forms of cancer, Cushing’s syndrome and other serious diseases. Recent data indicates, moreover, that it is effective as a “morning-after” pill, with only minor side effects. Anti-abortion groups fear that approval of the drug for its primary use as an abortifacient--safer than the conventional surgical procedure--would make abortion too easy.

While it is heartening that the FDA is now apparently willing to expedite approval of RU486, that’s not enough. The import alert will apparently remain in effect until President-elect Clinton lifts it, as he has promised to do.

Of greater concern, RU486’s manufacturer, Roussel-Uclaf of France, is still reluctant to seek FDA approval of the drug, fearing consumer boycott of its other products led by anti-abortion groups. Nonetheless, the Clinton Administration should urge Roussel to begin the FDA approval process; four American companies have indicated interest in a licensing agreement with Roussel to market RU486 in the United States. These firms must be encouraged.

Perhaps the divisive battle over the approval of RU486 is, finally, beginning to end. If so, we hope that the lasting lesson will be that reproductive health policy should not be held hostage by politics. When it is, the result is often bad policy--and bad medicine.