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FDA Approves Controversial European Pill for Abortions

By Marc Kaufman
THE WASHINGTON POST -- WASHINGTON

The controversial abortion drug RU-486 won long-sought approval from the federal government Thursday for sale in the United States, launching what both opponents and advocates agree will be a new era in the nation’s rancorous abortion debate.

The Food and Drug Administration decision for the first time gives American women an alternative to a surgical abortion: a pill that will be widely available and allow women to abort a pregnancy in the privacy of their own homes.

The drug is expected to be available within a month and cost about the same as a standard abortion. It will be administered first at clinics that have received special training, but eventually by any doctor who can ensure that a standard abortion will be available in the rare instances that the pill fails.

As a result, the pill is expected to fundamentally transform the abortion experience for millions of American women. Instead of facing the prospect of a potentially hostile environment outside a clinic, they could abort their pregnancies much more discreetly, much earlier, and with what many women describe as a greater sense of control.

The announcement was immediately hailed by abortion supporters as a breakthrough for American women and condemned by abortion opponents as a travesty for endangering human life.

Gloria Feldt, president of Planned Parenthood of America, called the approval “an historic moment, comparable to the arrival of the birth control bill forty years ago.” Kate Michelman of the National Abortion and Reproductive Rights League called it a “milestone on the long road to women’s reproductive freedom and equality in this country.”

But Laura Echevarria, spokes-person of the National Right to Life Committee, said approval would mark an unfortunate turning point for the country. “In the past, the FDA has approved drugs to save lives and prolong lives,” she said. “Now they are approving a drug designed to take human life.”

The decision quickly became part of the presidential campaign. Vice President Al Gore said the “decision is not about politics, but the health and safety of American women and a woman’s fundamental right to choose.” Texas Gov. George W. Bush called it “wrong,” and said he feared it would make abortions “more and more common rather than more and more rare.”

Republican leaders have made clear they want to overturn the decision, and House Republican Conference Chairman J.C. Watts, Jr. (R.-Okla.), said Thursday that “a new administration, I am certain, with moral leadership and a commitment to the family will reverse this Clinton-Gore decision.”

President Clinton criticized as political the Republican attack on Thursday’s decision. “This administration treated that issue as purely one of science and medicine,” he said. “And the decision to be made under our law is whether the drug should be approved by the FDA on grounds of safety.”

The intense feelings about the pill were manifested in two aspects of Thursday’s decision. FDA Commissioner Jane Henney said the agency for the first time did not publish the names of the experts who reviewed RU 486 for the agency. In addition, it broke precedent by not publishing the name or location of the manufacturer.